criteria for acceptability of radiological, nuclear...

CRITERIA FOR

ACCEPTABILITY OF

RADIOLOGICAL,

NUCLEAR MEDICINE

AND RADIOTHERAPY

EQUIPMENT

FINAL DRAFT AMENDED-V1.4-091001

E U R O P E A N C O M M I S S I O N

C O N T R A C T N O . T R E N / 0 7 / N U C L / S 0 7 . 7 0 4 6 4

Radiation Criteria For Acceptability Of Radiological, Nuclear Medicine And Radiotherapy Equipment

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FOREWORD (TO BE WRITTEN BY THE CEC)

Notes that may be useful aide memoir for Foreword:

Background to directives

Key points to be mentioned by the Commission

Key changes

More detailed report, extended in length from about 20 to over 100 pages.

Much more explicit attention to Radiotherapy and Nuclear Medicine.

Definition creep. Use of Suspension Levels (redefined) as key component of definition. Evidence base for criteria, and their classification according to evidence base. Some areas not as developed as we would have liked and evidence base for criteria in short supply.

Inclusion of process for dealing with exceptions including rapidly changing technology.

Harmonisation with requirements of MDD.

New: More explicit statements of process to be used for application of Criteria in practice.

The Commission is grateful to Dr Keith Faulkner who coordinated the overall project and to Professor Jim Malone (Introduction and Diagnostic Radiology Lead), Dr Stelios Christofides (Nuclear Medicine Lead) and Professor Stephen Lillicrap (Radiotherapy Lead), who coordinated the work in the specialist areas indicated.

FOREWORD TO ORIGINAL DOCUMENT

The work of the European Commission in the field of radiation protection is governed by the

Euratom Treaty and the Council Directives made under it.

The most prominent is the Basic Safety Standards Directive (BSS) on the protection of

exposed workers and the public (80/836/Euratom) revised in 1996 (96/29/Euratom).

In 1984 Council issued a complementary Directive to the BSS on the protection of persons

undergoing medical exposures (84/466/Euratom) revised in 1997 (97/43/Euratom).

Both Directives require the establishment by the Member States of criteria of acceptability of

radiological (including radiotherapy) installations and nuclear medicine installations.

Experience showed that drawing up such criteria, especially as regards the technical

parameters of the equipment, sometimes created difficulties.

Therefore in 1990, the Commission took the initiative to develop examples of criteria of

acceptability (Bland, N.R.P.B.).

Following two constructive meetings with competent authorities of the Member States

(18/9/1992 and 30/3/1994) a need for extension to specific radiological and nuclear medicine

installations was forwarded. In 1995 an inquiry among competent authorities was made (Kal

& Zoetelief) to make an evaluation of the existing situation resulting in a new report

suggesting additional criteria for these installations.

This report, amended with data from other sources, was discussed with competent

authorities in Luxembourg on 4 and 5 September 1996.

The result is a flavour of criteria of acceptability applicable to facilities in use for radiology,

radiotherapy and nuclear medicine. These criteria are not binding to the Member States but

were prepared to assist competent authorities in their task to establish or to review criteria of

acceptability, also called minimum criteria. They should not be confused with the

requirements for design and construction of radiological and nuclear medicine equipment as

mentioned in annex I, part 2, § 11,5 of the Council Directive on medical devices (93/42/EEC).

This report will be reviewed on a regular basis in order to take into account new scientific and

technical data as appropriate.

It forms part of a series of technical guides on different subjects developed to facilitate the

implementation of the Directive on medical exposures. It is my hope that the document will

help to ensure continuing improvement in radiation protection in the medical field.

Suzanne FRIGREN

Director Nuclear Safety and Civil Protection


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CONTENTS

FOREWORD (To be written by the CEC) ______________________________________________ 2

FOREWORD TO ORIGINAL DOCUMENT ______________________________________________ 3

CONTENTS ______________________________________________________________________ 4

1. INTRODUCTION ______________________________________________________________ 6

1.1. Purpose and Background __________________________________________________ 6

1.2. Basis for Criteria of Acceptability in European Directives _______________________ 8 1.2.1. Requirements of the Medical Exposure Directive _____________________________ 8 1.2.2. Wider context, the MDD Directive and Equipment Standards __________________ 10

1.3. To whom this document is addressed ______________________________________ 12

1.4. Criteria of Acceptability __________________________________________________ 13 1.4.1. Approaches to Criteria _________________________________________________ 13 1.4.2. Suspension Levels ___________________________________________________ 14 1.4.3. Identifying and Selecting Criteria _________________________________________ 16

1.5. Special Considerations, Exceptions and Exclusions __________________________ 18 1.5.1. Special Considerations ________________________________________________ 18 1.5.2. Exceptions __________________________________________________________ 19 1.5.3. rapidly evolving technologies ____________________________________________ 19 1.5.4. Exclusions __________________________________________________________ 20

1.6. Establishing criteria of acceptability have been met ___________________________ 20

2. DIAGNOSTIC RADIOLOGY ____________________________________________________ 23

2.1. Introduction ____________________________________________________________ 23

2.2. X-Ray Generators and equipment for General Radiography ____________________ 24 2.2.1. Introduction _________________________________________________________ 24 2.2.2. Criteria for X-Ray Generators, and General Radiography _____________________ 27

2.3. Radiographic Image Receptors and Viewing Facilities _________________________ 30 2.3.1. Introduction _________________________________________________________ 30 2.3.2. Criteria for Image Receptors and Viewing Facilities __________________________ 32

2.4. Mammography __________________________________________________________ 38 2.4.1. Introduction _________________________________________________________ 38 2.4.2. Measurements _______________________________________________________ 39

2.5. Dental Radiography ______________________________________________________ 42 2.5.1. Introduction _________________________________________________________ 42 2.5.2. Intra-Oral Systems ____________________________________________________ 42 2.5.3. Criteria for Dental Radiography __________________________________________ 43 2.5.4. Panoramic radiography ________________________________________________ 44 2.5.5. Cephalometry _______________________________________________________ 44

2.6. Fluoroscopic Systems ___________________________________________________ 45 2.6.1. Introduction _________________________________________________________ 45 2.6.2. Criteria for Acceptability of Fluoroscopy Equipment __________________________ 46

2.7. Computed Tomography __________________________________________________ 47 2.7.1. Introduction _________________________________________________________ 47 2.7.2. Criteria for Acceptability of CT Systems ___________________________________ 49

2.8. Dual Energy X-ray Absorptiometry _________________________________________ 50 2.8.1. Introduction _________________________________________________________ 50 2.8.2. Acceptability Criteria for DXA Systems ____________________________________ 50

3. NUCLEAR MEDICINE EQUIPMENT _____________________________________________ 51


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3.1. Introduction ____________________________________________________________ 51

3.2. Nuclear Medicine Therapeutic Procedures ___________________________________ 53 3.2.1. Introduction _________________________________________________________ 53 3.2.2. Activity Measurement Instruments _______________________________________ 54 3.2.3. Contamination Monitors ________________________________________________ 54 3.2.4. Patient Dose Rate Measuring Instruments _________________________________ 55 3.2.5. Radiopharmacy Quality Assurance Programme _____________________________ 56

3.3. Radiopharmacy for Gamma Camera based Diagnostic Procedures ______________ 57 3.3.1. Introduction _________________________________________________________ 57 3.3.2. Activity Measurement Instruments _______________________________________ 58 3.3.3. Gamma Counters ____________________________________________________ 58 3.3.4. Thin Layer Chromatography Scanners ____________________________________ 59 3.3.5. Contamination monitors ________________________________________________ 59

3.4. Radiopharmacy for Positron Emission Based Diagnostic Procedures ____________ 60

3.3 Gamma Camera based Diagnostic Procedures _______________________________ 60 3.3.1 Introduction ___________________________________________________________ 60 3.4.1. Planar Gamma Camera ________________________________________________ 61 3.4.2. Whole Body IMAGING System __________________________________________ 62 3.4.3. SPECT System ______________________________________________________ 63 3.4.4. Gamma Cameras used for Coincidence Imaging ____________________________ 64

3.5. Positron Emission Diagnostic Procedures ___________________________________ 65 3.5.1. Introduction _________________________________________________________ 65 3.5.2. Positron Emission Tomography System ___________________________________ 66 3.5.3. Hybrid Diagnostic Systems _____________________________________________ 67

3.4 Intra-Operative Probes ___________________________________________________ 68

4 RADIOTHERAPY ____________________________________________________________ 70

3.6. Introduction ____________________________________________________________ 70

3.3 Linear accelerators ______________________________________________________ 71

3.7. Simulators _____________________________________________________________ 74

3.8. CT Simulators __________________________________________________________ 77

3.9. Cobalt-60 units __________________________________________________________ 80

3.10. Kilovoltage Units ______________________________________________________ 82

3.11. Brachytherapy ________________________________________________________ 83

3.12. Treatment Planning Systems ____________________________________________ 84

3.13. Dosimetry Equipment __________________________________________________ 85

3.14. Radiotherapy Networks ________________________________________________ 86

APPENDIX 1 INFORMATIVE NOTE ON IMAGING PERFORMANCE _______________________ 89

APPENDIX 2 AUTOMATIC EXPOSURE CONTROL ____________________________________ 90

APPENDIX 3 EQUIPMENT _________________________________________________________ 91

REFERENCES & SELECTED BIBLIOGRAPHY ________________________________________ 93

ACKNOWLEDGEMENTS _________________________________________________________ 104


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1. INTRODUCTION

1.1. PURPOSE AND BACKGROUND

The purpose of this publication is to specify minimum performance standards for

radiological, nuclear medicine and radiotherapy equipment. The criteria of

acceptability presented here are based on levels of performance that prompt

intervention and will result in the use of the equipment being curtailed or terminated,

if not corrected. The criteria are produced in response to Directive 97/43/Euratom,

which requires that medical exposures be justified and carried out in an optimized

fashion. To give effect to this Directive, Article 8.3 stipulates that Member States

shall adopt criteria of acceptability for radiological equipment in order to indicate

when action is necessary, including, if appropriate, taking the equipment out of

service. In 1997, the Commission published Radiation Protection 91: Criteria for

acceptability of radiological (including radiotherapy) and nuclear medicine

installations (EC, 1997), in pursuit of this objective. This specified minimum criteria

for acceptability and has been used to this effect in legislation, codes of practice and

by individual professionals throughout the member states and elsewhere in the world.

RP 91 considered diagnostic radiological installations including conventional and

computed tomography, dental radiography, and mammography, radiotherapy

installations and nuclear medicine installations. However, development of new

radiological systems and technologies, improvements in traditional technologies and

changing clinical/social needs have created circumstances where the criteria of

acceptability need to be reviewed to ensure the principles of justification and

optimization are upheld. To give effect to this, the Commission, on the advice of the

Article 31 Group of Experts, initiated a study aimed at reviewing and updating RP 91

(EC, 1997), which in due course has led to this publication.

This revised publication is, among other features, intended to:

1. Update existing acceptability criteria.

2. Update and extend acceptability criteria to new types of installations. In diagnostic

radiology, the range and scope of the systems available has been greatly


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extended (e.g. computed radiography, digital radiography, digital fluoroscopy,

multislice computed tomography (CT) and dual energy x-ray absorptiometry

(DXA)). In nuclear medicine, there are Positron Emission Tomography (PET)

systems and hybrid scanners. In radiotherapy, there are linear accelerators with

multileaf collimators capable of intensity modulated radiotherapy (IMRT).

3. Identify an updated and more explicit range of techniques employed to assess

criteria of acceptability,

4. Provide criteria that have a reasonable opportunity of being accepted, and that

are achievable throughout the member states.

5. Deal, where practical, with the implications for screening techniques, paediatrics,

high dose techniques and other special issues noted in the 1997 Directive.

6. Promote approaches based on an understanding of and that attempt to achieve

consistency with those employed by the Medical Devices Directive (MDD)

(Council Directive 93/42/EEC), industry, standards organizations and professional

bodies.

7. Make practical suggestions on implementation and verification.

To achieve this, the development and review process has involved a wide range of

individuals and organizations, including experts from relevant professions,

professional bodies, industry, standards organizations and relevant international

organizations. It was easier to achieve the last objective with radiotherapy than with

diagnostic radiology. This is because of a long tradition of close working relationships

between the medical physics and international standards communities, which has

facilitated the development and adoption of common standards in radiotherapy. An

attempt has been made, with the cooperation of the International Electrotechnical

Commission (IEC), to import this approach to the deliberations on diagnostic

radiology and to extend it, where it already exists, in nuclear medicine.

The intent has been to define parameters essential to the assessment of the

performance of radiological medical installations and set up tolerances within which

the technical quality and equipment safety standards for medical procedures are


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ensured. The methods for performance assessment recommended generally rely on

non-invasive measurements open to the end user. This publication will benefit the

holder of radiological installations, bodies responsible for technical surveillance and

authorities charged with verifying compliance of installations with regulations on

grounds of technical safety. However, it is important to bear in mind that the present

publication follows the precedent established in RP 91, is limited to the equipment

and does not address wider issues such as those associated with, for example, the

requirements for buildings and installations, information technology (IT) systems such

as picture archiving and communication systems (PACS) and/or radiological

information systems (RIS).

1.2. BASIS FOR CRITERIA OF ACCEPTABILITY IN EUROPEAN DIRECTIVES

1.2.1. REQUIREMENTS OF THE MEDICAL EXPOSURE DIRECTIVE

The work of the European Commission in the field of radiation protection is governed

by the Euratom Treaty and the Council Directives made under it. The most

prominent is the Basic Safety Standards Directive (BSS) on the protection of

exposed workers and the public (Council Directive 80/836/Euratom), revised in 1996

(Council Directive 96/29/Euratom). Radiation protection of persons undergoing

medical examination was first addressed in Council Directive 84/466/Euratom. This

was replaced in 1997 by Council Directive 97/43/EURATOM (MED) on health

protection of patients against the dangers of ionizing radiation in relation to medical

exposure. This prescribes a number of measures to ensure medical exposures are

delivered under appropriate conditions. It makes necessary the establishment of

quality assurance programmes and criteria of acceptability for equipment and

installations. These criteria apply to all installed radiological equipment used with

patients.

The directive also deals with the monitoring, evaluation and maintenance of the

required characteristics of performance of equipment that can be defined, measured

and controlled. In particular, it requires that all doses arising from medical exposure

of patients for medical diagnosis or health screening programmes shall be kept as

low as reasonably achievable consistent with obtaining the required diagnostic


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information, taking into account economic and social factors (ALARA). Specifically,

the requirements in respect of criteria of acceptability are stated as follows:

“Competent authorities shall take steps to ensure that necessary measures are taken

by the holder of the radiological installation to improve inadequate or defective

features of the equipment. They shall also adopt specific criteria of acceptability for

equipment in order to indicate when appropriate remedial action is necessary,

including, if appropriate, taking the equipment out of service.”

Additional requirements in respect of image intensification and dose monitoring

systems are explicitly specified. These extend to all new equipment which:

“shall have, where practicable, a device informing the practitioner of the quantity of

radiation produced by the equipment during the radiological procedure.”

Finally Article 9 requires that:

“Appropriate radiological equipment ----- and ancillary equipment are used for the

medical exposure

of children,

as part of a health screening programme,

involving high doses to the patient, such as interventional radiology, computed

tomography or radiotherapy.”

And that:

“Special attention shall be given to the quality assurance programmes, including

quality control measures and patient dose or administered activity assessment, as

mentioned in Article 8, for these practices.”

Practical consequences of these requirements are that:


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1. Acceptance testing must be carried out before the first use of the equipment

for clinical purposes to ensure it complies with its performance specification

and to provide reference values for future performance testing.

2. Further performance testing must be undertaken on a regular basis, and after

any major maintenance procedure.

3. Necessary measures must be taken by the holder of the radiological

installation to improve inadequate or defective features of the equipment.

4. Competent authorities must adopt specific criteria of acceptability for

equipment in order to indicate when appropriate action is necessary, including

taking the equipment out of service.

5. Appropriate quality assurance programmes including quality control measures

must be implemented by the holder of the radiological installation.

This publication deals with the first four points and will be germane to some aspects

of the fifth. It updates and extends the advice provided in 1997 in RP 91 (EC, 1997).

However, this document is not intended to act as a guide to quality assurance or

quality control programmes, which are comprehensively dealt with elsewhere (CEC

2006; APPM 2006a, b; IPEM 2005a, b; AAPM 2002; BIR 2001; Seibert 1999; IPEM,

1997a, b, c).

1.2.2. WIDER CONTEXT, THE MDD DIRECTIVE AND EQUIPMENT STANDARDS

Since 1993, safety aspects of design, manufacturing and placing on the market of

medical devices are dealt with by MDD. It is managed by the European Directorate

General Enterprise; its main goal is to define and list the Essential Requirements,

which must be fulfilled by Medical Devices. When such a device is in compliance

with the Essential Requirements of the MDD, it can be “CE marked”, which opens the

full European market to the product.

There are a number of ways with which manufacturers can demonstrate that their

products meet the Essential Requirements of the MDD; the one of most interest here

involves international standards. Further, demonstration of conformity with the


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essential requirements must include a clinical evaluation. Any undesirable side-

effects must constitute an acceptable risk when weighted against the performance

intended. For the types of system that are the subject of this publication,

demonstration of the essential requirements can be achieved by the procedures

described in the directive annexes. Conformity of all or part of these requirements

can be demonstrated or verified through compliance with harmonised international

standards. These are standards that specify essential requirements for the basic

safety and essential performance of the device, such as those issued by the IEC or

Comité Européen de Normalisation Electrotechnique (CENELEC).

Although the MDD includes requirements for devices emitting ionising radiation, this

does not affect the authorisations required by the directives adopted under the

Euratom treaty when the device is brought into use. In this regard, the Euratom

Treaty directives have precedence over the MDD. Conformity with an IEC or

CENELEC standard will frequently be included as part of the suppliers‟ specification

and will be confirmed during contractual acceptance (acceptance testing) of the

equipment by the purchaser. On the other hand the acceptability criteria in this

publication must be met during the useful life of the equipment and its compliance

with them will generally be regularly assessed.

The MDD was substantially amended by Directive 2007/47/EC. The amendments

include an undertaking by the manufacturer to institute and keep up to date a

systematic procedure to review experience gained from devices in the post-

production phase and to implement appropriate means to apply any necessary

corrective action. Furthermore, the clinical evaluation and its documentation must

be actively updated with data obtained from the post-market surveillance. Where

post-market clinical follow-up as part of the post-market surveillance plan for the

device is not deemed necessary, this must be duly justified and documented.

In transposing these European directives into national law, the acceptability criteria

required by the MED may be transposed into national law using country specific

criteria and approaches. It is clear that this may undermine the applicability essential

performance standards as required by the MDD or through compliance with the

international standardisation system. Such an approach conflicts with the concept of

free circulation and suppression of barriers to trade, which is one of the goals of the


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EU in general and the MDD in particular. To avoid these difficulties there is an

urgent and clear need for harmonisation between the requirements of the two

directives (MDD and MED). Thus it is desirable that all EU countries both transpose

the MED requirement for criteria of acceptability in a consistent fashion that will not

harm the efforts under the MDD, the standards and CE marking systems, to ensure

free circulation of goods and suppress trade barriers. The approach advocated in

this publication is consistent with this objective.

Thus, care must be exercised transposing the requirements of the MED based on

either partial or inappropriate adoption of this publication as national legislation.

Where this is envisaged, some caution is necessary and due discretion must be

allowed in respect of the clinical situations envisaged in this introduction and the

associated technology specific sections. Furthermore, adopting a regulation based

solely on national radiation protection considerations without due regard for the

issues arising from the MDD is likely to prove counterproductive for both suppliers

and end users. At a national level, the solution adopted should ensure patient safety

while fostering a cooperative framework between industry, standards, end users and

regulators. Internationally, there is a clear need for harmonization and a level of

uniformity between countries in recognition of the global nature of the equipment

supply industry. It is further necessary that there be harmonization between industry

and users, at least in terms of the methodologies employed.

1.3. TO WHOM THIS DOCUMENT IS ADDRESSED

Regulatory documents and standards, with respect to equipment performance, can

be addressed to or focused primarily on the needs or obligations of a particular

group. For example, the standards produced by IEC and CENELEC are primarily

aimed at manufacturers and suppliers. Many of the tests they specify are type tests

that could not be done in the field.

However, the possible audiences for this publication include holders, end users,

regulators, industry and standards organizations. It is recognized that each of these

has a necessary interest in this publication and its application. It was recognized that

the primary audience for the publication is the holders and end-users of the

equipment (specifically, the health agencies, hospitals, other institutions,


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practitioners, medical physicists and other staff and agents, who deploy the

equipment for use with patients). In addition, it was recognized that it must reflect the

requirements of regulators when they are acting in the medical area in the interests

of end users and/or patients. This is in keeping with the precedent implicitly

established through the scope and format adopted for RP 91. This publication

addresses the needs of these groups while taking due account of the reality of

globalization of the industry, standards and the harmonization objectives viz a viz the

MDD noted elsewhere. The technical parts of Sections 2, 3, and 4 assume those

reading and using them are familiar with this introduction and have a good working

knowledge of the relevant types of equipment and appropriate testing regimes.

1.4. CRITERIA OF ACCEPTABILITY

1.4.1. APPROACHES TO CRITERIA

Approaches to describing the acceptability and performance of equipment have

varied. They inevitably include requirements specifically prescribed in the directive,

such as:

“In the case of fluoroscopy, examinations without an image intensification or

equivalent techniques are not justified and shall therefore be prohibited”,

or,

“Fluoroscopic examinations without devices to control the dose rate shall be limited

to justified circumstances.”

With respect to other areas, they range from provision of hard numerical values for

performance indices to detailed specification of measurement methodologies without

indicating the performance level to be accepted. The latter approach has come to be

favoured in many of the standards issued by bodies like IEC or CENELEC and by

some professional bodies.1 While this approach has the advantage that it is

1 The IEC is the world's leading organization that prepares and publishes International Standards for all electrical, electronic and

related technologies. IEC standards cover a vast range of technologies, including power generation, transmission and distribution to home appliances and office equipment, semiconductors, fibre optics, batteries, and medical devices to mention just a few. Many, if not all, of the markets involved are global. Within the EU CENELEC is the parallel standards organization and in practice adopts many IEC standards as its own aligning them within the European context.


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easier/possible to get consensus on it among the manufacturers, professions and

other interests involved, it also has some disadvantages. These include an evident

lack of transparency, associated limitations on accountability and risks of

misapplication in the hands of inexperienced users.

A comprehensive, consistent suite of approaches to performance and safety

assessment of radiological equipment has been proposed by the UK Institute of

Physics and Engineering in Medicine (IPEM, 2005a, b; IPEM, 1997a, b, c]. The

American Association of Physics in Medicine (AAPM,, 2006a, b, 2005, 2002) and

British Institute of Radiology (BIR, 2001) have also, among other professional

organizations, published much useful material. The IPEM system is based on the

assumption that deviations from the baseline performance of equipment on

installation will provide an adequate means of detecting unsafe or inadequately

performing equipment. This approach is questionable within the meaning of criteria

of acceptability in the MED; if the baseline is, for one reason or another,

unsatisfactory, there are no criteria on which it can be rejected. In light of this issue,

the approach more recently favoured by IPEM and many standards organizations

has not been adopted in most instances. Where possible, the emphasis has been to

propose firm suspension levels. This is consistent with the approach adopted in

many countries, including, for example, France, Germany, Belgium, Spain, Italy,

Luxembourg and others which have adopted hard limits for performance values

based on RP 91 or other sources.

1.4.2. SUSPENSION LEVELS

A critical reading of the directive, RP 91 and the professional literature reveals some

shift or “creep” in the meaning of the terms remedial and suspension level since they

came into widespread use in the mid 1990s. In the interest of clarity, we have

redefined them in a way that is consistent with both their usage in the Directive and

their current usage, as follows:

Definition of Suspension Levels:

A level of performance that requires the immediate removal of the equipment

from use.


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Following a documented risk assessment involving the Medical Physics Expert

(MPE) and the practitioner, the suspended equipment may be considered for use in

limited circumstances. The holder and the operators must be advised in writing of the

suspension and/or the related limitation(s) in use. 2

A suspension level not being met requires that the equipment is taken out of service

immediately. Not meeting the level makes the equipment unsafe, or performance so

poor, that it would be unacceptable to society. The level is based on minimum

standards of safety and performance that would be acceptable in the EU and

represent the expert judgement of the working group and reviewers based on their

knowledge of what is acceptable among their peers and informed by the social, legal

and political circumstances that prevail in the EU. When suspension levels are

reached the equipment must be removed from use (or restricted in use) with patients,

either indefinitely or until it is repaired and again satisfies the criteria.

It is also possible that the equipment will pass an evaluation based on suspension

levels but be unsatisfactory in some other way. This may be because we have

mainly considered suspension levels as performance tolerances (particularly in

radiotherapy) whereas equipment may very well fail on safety issues which are

covered by the IEC general standards 60601-1 (IEC, 2003b) and associated

collateral and particular standards. Many quality assurance manuals refer to the

levels triggering such actions as remedial levels. In line with the precedent

established in RP 91 (EC, 1997), the main thrust of this publication is concerned with

suspension levels. Remedial levels are, on the other hand, well described in

numerous quality assurance publications detailing them (AAPM, 2005; IPEM, 2005a,

b; AAPM, 2002; EC, 1997, IPEM, 1997a, b, c; et al).

Suspension levels are taken as the criteria of acceptability. They must be clearly

distinguished from the levels set for acceptance tests. The latter are used to

establish that the equipment meets the supplier‟s specification or to verify some other

contractual issue; they may be quite different from the criteria of acceptability

2 Examples of how this might arise include the following: 1.In radiotherapy, a megavoltage unit with poor isocentric accuracy

could be restricted to palliative treatment until the unit could be replaced. 2. In nuclear medicine, a rotational gamma camera with inferior isocentric accuracy could be restricted to static examinations. 3. In diagnostic radiology, an x-ray set with the beam limiting device locked in the maximum field of view position might be used to expose films requiring that format in specific circumstances.


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envisaged in the directive. However, it is entirely possible that equipment meeting

the requirements of the acceptance test will automatically pass the criteria of

acceptability. This is because the acceptance test for modern equipment will often

be more demanding than the criterion of acceptability. Tests based on the criteria of

acceptability should be performed on installation and thereafter regularly or after

major maintenance.

In practice, acceptability testing should assure the equipment tested is serviceable

and provides acceptable clinical image quality using acceptable patient radiation

doses. QA testing may involve additional elements beyond the acceptability and will

inevitably involve reporting many remedial levels. It is presumed that by the time

acceptability is considered, acceptance tests, compliance with manufacturer‟s

specifications and commissioning tests have been successfully performed.

Equipment may be significantly reconfigured during its useful life arising from

updating, major maintenance or changes in its intended use. If this is done,

appropriate new acceptability tests will be required.

1.4.3. IDENTIFYING AND SELECTING CRITERIA

It was not possible to devise a single acceptable approach to proposing values or

levels for the criteria selected. Instead a number of approaches, with varying

degrees of authority and consensus attaching to them, have been adopted and

grouped under headings A to D as follows:

Type A Criterion

This type of criterion is based on a formal national/international regulation or an

international standard.

A reasonable case can sometimes be made for using a manufacturer‟s specification

as a criterion of acceptability. For example, all CE marked equipment, which meets

specification, will either meet or exceed the essential safety standards with which the

equipment complies. Thus, testing to the manufacturer‟s specification could be taken

as a means of ensuring the criteria of acceptability are met or exceeded in the area

they address.


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A case can also be made that compliance with the relevant IEC, CENELEC or

national standards might be taken as compliance with criteria that the industry has

deemed to be essential for safety. In practice, this approach may be limited in value

as the tests required may not be within the competence of end users or service

engineers in the field. Thus different agreed approaches to verification will be

required. Development in this area is essential to the harmonization referred to

above. In particular, agreed methodology is essential in any system of equipment

testing. Standards organizations provide a useful role model in this regard, which

this publication has tried to emulate.3

Type B Criterion

This type of criterion is based on formal recommendations of scientific, medical or

professional bodies.

Where industrial standards are not available or are out of date, advice is often

available from professional bodies, notably IPEM, AAPM, NEMA, BIR, ENMS, ACR

et al. More detailed advice on testing individual systems is available from the AAPM,

earlier IPEM publications and a wide range of material published by many

professional bodies and public service organizations. Much of the material is peer

reviewed and has been a valuable source where suitable standards are not available.

Type C Criterion

This type of criterion is based on material published in well established scientific,

medical or professional journals.

Where neither standards nor material issued by professional bodies are available,

the published scientific literature has been consulted and a recommendation from the

drafting group has been proposed and submitted to expert review by referees.

Where this process led to a consensus, the value has been adopted and is

recommended below.

3 When equipment standards are developed so that their recommendations can be addressed to and accepted by both

“manufacturers and users”, the question of establishing criteria of acceptability becomes much simplified. Highly developed initiatives in this regard have been undertaken in radiotherapy (see IEC 60976 and IEC 60977). These “provide guidance to manufacturers on the needs of radiotherapists in respect of the performance of MEDICAL ELECTRON ACCELERATORS and they provide guidance to USERS wishing to check the manufacturer‟s declared performance characteristics, to carry out

(footnote continued)


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Type D Criterion

The Type D situation arises where it has not been possible to make a

recommendation. In a small residue of areas it has not been possible to make

recommendations for a variety of reasons. For example, where the technology

involved is evolving rapidly, listing a value could be counterproductive. It could

become out of date very rapidly or it could act as an inhibitor of development. In

such situations we feel the criterion of acceptability should be determined by the

institution holding the equipment based on the advice of the MPE or Radiation

Protection Adviser (RPA) as appropriate.

The criteria of acceptability proposed are identified as belonging to one or another of

these categories. In addition, at least one reference to the primary source for the

value and the method recommended is provided. Some expansion on the approach

and the rationale for the choice is provided, where deemed necessary in an

Appendix. Test methods are only fully described if they cannot be referred to in a

high quality accessible reference.

1.5. SPECIAL CONSIDERATIONS, EXCEPTIONS AND EXCLUSIONS

1.5.1. SPECIAL CONSIDERATIONS

The directive requires that special consideration be given to equipment in the

following categories:

Equipment for screening,

Equipment for paediatrics and

High dose equipment, such as that used for CT, interventional radiology, or

radiotherapy.

acceptance tests and to check periodically the performance throughout the life of the equipment”. This approach has much to offer other areas.


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The chapters and sections in the attached volumes dealing with the high dose group

(CT, interventional radiology or radiotherapy), deal comprehensively with this

requirement.

Equipment used for paediatrics and in screening programmes is often similar or

possibly identical to general purpose equipment. Where this is the case, additional

guidance for the special problems of paediatrics, such as the requirement for a

removable grid in general radiology or fluoroscopy and the special needs with regard

to CT exposure programmes are noted in the technology specific sections. The

special requirements for mammography are based on those appropriate to screening

programmes.

1.5.2. EXCEPTIONS

Exceptions to the recommended criteria may arise in various circumstances. These

include the cases cited in Section 1.2 above, where equipment compliant with safety

and performance standards that predate the criteria for acceptability has to be

assessed. In such cases, the MPE should make a recommendation to the end user

or holder, on whether or not this level of compliance is sufficient to meet the

intentions of the directive. These recommendations must take a balanced view of the

overall situation, including the economic/social circumstances, older technology etc.;

they may be nuanced in that the RPA/MPE may recommend that the equipment be

accepted subject to restrictions on its use. Likewise it is always well to remember

that acceptability criteria, as already outlined, may depend on the use(s) for which

equipment is deployed.

1.5.3. RAPIDLY EVOLVING TECHNOLOGIES

Medical imaging is an area in which many new developments are occurring.

Encouragement of development in such an environment is not well served by the

imposition of rigid criteria of acceptability. Such criteria, when rigorously enforced,

could become obstacles to development and thereby undermine the functionality and

safety they were designed to protect. In such circumstances, the MPE should

recommend to the end-user a set of criteria that are framed to be effective with the

new technology and that takes account of related longer established technologies,


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any IEC/CEN/CENELEC standards available, the manufacturer‟s recommendations,

the related scientific and professional opinion/published literature and the maxim that

the new technology should aspire to be at least as safe as existing technology it is

replacing.

1.5.4. EXCLUSIONS

Within this publication, the term “equipment” has been interpreted to mean the main

types of equipment used in diagnostic radiology, nuclear medicine and radiotherapy.

This follows the precedent established in RP 91 (EC, 1997). It is important to be

aware that the full installation is not treated. Thus, the requirements for an

acceptable physical building and shielding that will adequately protect staff, the public

and, on occasions, patients; power supplies and ventilation have not been

addressed. However, this is an area of growing concern and one in which the

requirements have changed considerably as both equipment and legislation have

changed. In addition the acceptable solutions to the new problems, arising from both

equipment development and legislation, in different parts of the world, are different.

Consequently, this area is now in need of focused attention in its own right.

Likewise, the contribution of IT networks to improving or compromising equipment

functionality can bear on both justification and optimization. This can apply to either

PACS or RIS networks in diagnostic radiology and imaging, planning and treatment

networks in radiotherapy centres. The requirements for acceptability of such

networks are generally beyond the scope of this publication, although they have been

included occasionally, for example in radiotherapy, where they are integral to the

treatment.

As already mentioned elsewhere, the publication focuses on criteria of acceptability

and it does not offer advice intended for use in routine Quality Assurance

programmes.

1.6. ESTABLISHING CRITERIA OF ACCEPTABILITY HAVE BEEN MET

The criteria of acceptability will be applied by the competent authorities in each

member state. The authorities for the MED are generally not the same as those for


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the MDD. In addition the criteria will be introduced and applied in the context of the

unfolding requirements for clinical audit in healthcare in general and in the

radiological world in particular. This is accompanied by a general increase in the

requirements for individual and institutional accreditation. Thus the holder of

radiological equipment should appoint a competent person to establish that the

criteria of acceptability have been met. The person appointed should be an MPE or

a person of similar standing. Who performs the tests to verify compliance is a matter

for local arrangements. Thus the MPE may choose to perform the tests themselves,

write them up, report on them and sign them off. Alternatively, he/she may accept

results provided by the manufacturer‟s team. These may have been acquired, for

example, during acceptance testing or commissioning. Results for tests performed to

agreed methodology will be satisfactory in many cases. They provide the information

on which the MPE can make a judgement on whether or not the equipment meets

the criteria. These two approaches represent the extremes. Most institutions will

establish a local practice somewhere between that allows the criteria to be verified

with confidence by a suitably qualified agent acting on behalf of the end user. In

radiotherapy, joint acceptance testing by the manufacturer‟s team and the holder‟s

MPE is commonplace. Whichever approach is taken, where a suspension level is

not met, the outcome and any associated recommendations from the MPE and/or the

practitioner must be communicated promptly, in writing, to both the holder and the

operators/users of the equipment.

In situations where the formally recommended criteria of acceptability are incomplete,

lack precision, or where the equipment is very old, subject to exception, special

arrangements or exemptions, the judgement and advice of the MPE becomes even

more important. Additional, more complete, measurements may be needed to

determine the cause of the change in performance. When equipment fails to meet

the criteria, agreement must be established on how it will be withdrawn from use with

patients. This must be done in association with the MPE whose advice must be

obtained. The options, in practice, include those mentioned above and include the

possibility of immediate withdrawal, where the failure of compliance is serious

enough to warrant it. Alternatively a phased withdrawal or limitations on the range of

use of the equipment may be considered. In the latter case, the specific

circumstances under which the equipment may continue to be used must be carefully


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defined and documented. In addition, the advice of the MPE to the practitioner and/or

the holder or the holder‟s representative must be made available in a prompt and

timely way, consistent with the recommendations for action.


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2. DIAGNOSTIC RADIOLOGY

The technical parts of Sections 2, 3, and 4 assume those reading and using them are

familiar with the introduction and have a good working knowledge of the relevant types of

equipment and appropriate testing regimes.

2.1. INTRODUCTION

Since RP 91 (EC, 1997), there have been a number of major developments in diagnostic

radiology. Perhaps the key new developments are the introduction of direct digital detectors

(e.g. large area flat panel detectors) for use in radiology and fluoroscopy, as well as multiple

slice computed tomography scanners. Both these new developments have implications for

acceptability criteria, but suspension levels in these areas are less mature.

Manufacturers have also incorporated information technology and other developments into

medical imaging systems which have resulted in radiological imaging equipment being

more stable. For instance, the stability of the applied tube potential produced by high

frequency generators has been much improved when compared with previous x-ray

generator designs (e.g. single phase). As equipment performance evolves, so do

acceptability criteria.

With the implementation of the quality culture within radiology departments and the

evolution of quality assurance programmes, criteria have also changed. In part the

availability of instrumentation for determination of radiation exposure in radiology linked to

computers has also impacted on measurement approaches and quality assurance.

However, in rapidly evolving areas of radiology, such as CT scanning, acceptability criteria

have not kept pace with technological developments. There is a deficit in consensus based

acceptability criteria for these areas of practice which will need to be addressed in the

future. Acceptability criteria for all types of diagnostic radiology equipment are summarised

in the following sections.


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2.2. X-RAY GENERATORS AND EQUIPMENT FOR GENERAL RADIOGRAPHY

2.2.1. INTRODUCTION

General radiographic systems still provide the great majority of X-Ray examinations. They

may be subdivided in practice into a number of subsidiary specialist types of system. This

section deals with the Suspension Levels applicable to X-Ray generators, and general

radiographic equipment. It also includes or is applicable to mobile systems, traditional

conventional tomography and tomosynthesis systems, system subcomponents/devices

such as automatic exposure control (AEC), and grids. Much of what is presented here is

also applicable to generators for fluoroscopic equipment. However, the criteria have not

been developed with specialized X-ray equipment in mind: dental, mammographic, CT and

DXA units are mentioned in sections 2.4, 2.5, 2.7, and 2.8.

The criteria here refer to X-ray tube and generator, output, filtration and half value layer

(HVL), beam alignment, collimation, the grid, AEC, leakage radiation and dosimetry.

Suspension/tolerance levels are specified in the Tables below. Before presenting them a

few aspects of half value layer and filtration, image quality, paediatric concerns, AEC,

mobile devices, and spatial resolution must be mentioned to ensure that the approach and

the Tables are interpreted correctly.

HVL/filtration

Total filtration in general radiography should not normally be less than 2.5 mm Al. The half

value layer (HVL) is an important metric used as a surrogate measurement for filtration. It

shall not be less than the values given in Table 2.1.


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Table 2.1 Minimum half-value layer (HVL) requirements

Application Values of x-ray tube

voltage. (kV)

Minimum permissible (HVL) in mm Al

(IEC 60601-1-3 (IEC, 2008a) and see Notes 1

and 2)

General

radiography x-

ray equipment

<50

50

60

70

80

90

100

110

120

>120

See note 3

1.8

2.2

2.5

2.9

3.2

3.6

3.9

4.3

see note 3

Note 1: These HVLs correspond to a total filtration of 2.5 mm Al for equipment operating at constant potential

in tungsten anode.

Note 2: Linear extrapolation to be used here.

Note 3: Test methods differ for different modalities.

Paediatric Issues

Requirements for radiography of paediatric patients differ from those of adults, partly

related to differences in size and immobilization during examination (see notes in Tables

throughout Section 2). Beam alignment and collimation are particularly important in

paediatric radiology, where the whole body, individual organs and their separation distance

are smaller. The x-ray generator and tube must have sufficient power to make short

exposure times possible. In addition the option to remove the grid from a radiography

table/image receptor is essential in a system for paediatric use, as is the capacity to disable

the AEC and use manual factors. Systems used with manual exposures (like dedicated

mobile units for bedside examinations) should have exposure charts for paediatric patients.

Image Quality and Spatial Resolution

There are unresolved difficulties in determining objective measures of image quality that are

both reproducible and reflect clinical performance. Measurements here are limited to high


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contrast bar patterns, and may be augmented by subjective or semi subjective

assessments at the discretion of the MPE and the Practitioner. (Appendix 1)

Automatic exposure control for any radiographic detector

The AEC should provide limitation of under- and overexposure of the receptor and

exposure time. Digital generators also require that pre-programmed exposure systems be

assessed to ensure acceptability based on the suppliers‟ specification and the MPE‟s

evaluation. It may also, at the discretion of the MPE, and subject to its being an agreed

part of the equipment specification with the supplier, include assessment of Ka,e for a

specific type of examination (see Table 2.2 below for radiographic detectors (method in

Appendix 2). This should be such that the Ka,e for the patient phantom is below an agreed

diagnostic reference level (DRL). In addition, the optical density of the film should be

between 1.0 and 1.5 OD (SBHP-BVZF, 2008).

Table 2.2 Examples of image receptor Ka,e for various examinations for some specific

conditions see note 1

Examination Image receptor entrance air

kerma (incl. back scatter)

Ka,e (μGy)

PMMA

thickness (cm)

Tube

voltage

(kVp)

Abdomen radiograph adult) 5 20 80

Chest radiograph (adult) 5 11 120

Chest radiograph (child) 5 8 80

Note 1: For method see Appendix 2; this also includes some information on CR and DDR.

Mobile devices

For mobile devices the criteria for equipment for general radiography are applicable except

the requirements for alignment, which cannot be met in practice.

Conventional tomography

The parameters for conventional tomography equipment include cut height level, cut plane

incrementation, exposure angle, cut height uniformity and spatial resolution.


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2.2.2. CRITERIA FOR X-RAY GENERATORS, AND GENERAL RADIOGRAPHY

Table 2.3: Criteria for Acceptability of General Radiography Systems

Physical Parameter Suspension Level Reference Type Notes (Paediatrics)

Mechanical and

electrical safety

If defects pose an

immediate mechanical

or obvious electrical

hazard to patients or

staff

IEC 60601

Series

A Mechanical and

electrical safety

failures can be the

source of accidents

X-RAY SYSTEM

x-ray tube and

generator

tube voltage

accuracy

A Lower kVp often used

in paediatrics (EC,

1996c)

Dial calibration Maximum deviation: >

± 10% or ± 10 kV

EC (1997)

IPEM (2005a)

A

B

Variation with tube

current

Maximum variation: >

± 10%

EC (1997) B

Precision of tube

voltage

Deviation > ± 5% from

mean

EC (1997) A

x-ray tube output

Magnitude of output Y(1m) > 25 μGy/mAs

at 80 kV and 2.5 mm

Al

EC (1997) A

Consistency of output Y within ± 20% of

mean

EC (1997 )

IPEM (2005a)

B

Consistency of output

for range of qualities

Y within ± 20% of

mean

IPEM (2005a) B

Half-value layer (HVL

) /total filtration

HVL or sufficient total

filtration

HVL in excess for

values in Table 8.1

IEC (2008) A Additional Cu filtration

0.1 or 0.2 mm (EC,

1996c) (A)

Exposure time

Consistency of

exposure time

Actual exposure time

>

± 20% of indicated

value for values >

100ms

EC (1997)

IPEM (2005a)

A

B

Consistency and

absolute values

required for shorter

exposures,

particularly in

paediatrics (EC,

1996c)

Alignment

x-ray/light beam

alignment

Sum of misalignment

in principle directions

> 3% of dFID

IPEM (2005a) B


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Orthogonality of x-ray

beam and image

receptor (IR)

The angle between

central beam axis and

IR ≤ 1.5º from 90º

EC (1997) A

Collimation

Collimation of x-ray

beam

x-ray beam within

borders of image

receptor

EC (1997) A

Automatic collimation X-ray beam shall not

differ by more than

2% of dFID at any side

of image receptor

Borders within IR

EC (1997) A

Grid A Grids preferably not

to be used with

children (EC, 1996c)

Grid artefacts No artefacts should be

visible

EC (1997) A

Moving grid Lamellae should not

be visible on image

EC (1997) A

AEC verification See also Appendix 2

Focal spot (FS) size

through assessment

of spatial resolution

A Smaller sizes may be

required for various

applications including

paediatrics (EC,

1996c)

Spatial resolution

(limited by FS size

and detector

characteristics)

Spatial resolution ≥

1.6 lp/mm

JORF (2007a) B DIN standard

Limitation of

overexposure

Maximal focal spot

charge < 600 mAs

EC (1997) A Much equipment is

non compliant in

practice.Should this

be modified.

Limitation of exposure

time

Maximum exposure

time: 6s

EC (1997) A

Consistency of AEC

unit

Ka may not differ by

more than 10% from

mean value

SBPH-BVZ

(2008)

B See also Appendix 2

Verification of Ka,e at

image receptor for

reference examination

See table 2.2.

1.0 < OD >1.5

SBPH-BVZ

(2008)


Verification of sensors

of AEC

Film density for each

sensor may not differ

by more than 0.2 OD

from mean value

SBPH-BVZ

(2008)

B For chest

examinations sensors

are different on

purpose.

See also Appendix 2

Verification of AEC at Film density for a SBPH-BVZ B See also Appendix 2


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various phantom

thicknesses

phantom thickness

differs by more than

0.3 OD from mean

value for all

thicknesses

(2008)

Verification of AEC at

various tube voltages

Film density at a tube

voltage may not differ

by more than 0.2 OD

from mean value for

all tube voltages

SBPH-BVZ

(2008)


Dose to plate in CR

and DDR Systems

under AEC

≥ 10 μGy/plate Walsh et al

(2008.)

C NOTE: This is double

the max normally

encountered (3-5

uGy/plate). Grid in

position for this

measurement.

AEC performance in

CR and DDR

Systems:

> 50%*

Walsh et al

(2008)

C * >50% variation

allowed for 5 cm

PMMA.

Leakage radiation

Leakage radiation Ka(1m) < 1mGy in one

hour at maximum

rating

EC (1997) A

Dosimetry

For KAP meters see

2.6

Image quality Spatial better than 2.8

lp/mm for dose < 10

μGy.

And better than 2.4

lp/mm for dose < 5

μGy.

DIN 6868-58

(2001)

B Use phantom

described in the

standard

Contrast All seven steps are

not visible

DIN 6868-58

(2001)

B Use phantom

described in the

standard


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Table 2.4: Criteria for Acceptability of Conventional Tomography Systems

Physical Parameter Suspension Level Reference Type

Cut height level Difference between indicated and measured

value < 5 mm

EC (1997) A

Cut plane incrementation Reproducibility cut height < 2 mm EC (1997) A

Exposure angle Indicated and measured angle should agree

within 5° for angles more than 30°.

Agreement better for smaller angles

EC (1997) A

Cut height uniformity Image should reveal no overlaps,

inconsistencies of exposures, or

asymmetries in motion

EC (1997) A

Spatial resolution Resolution < 1.6 lp/mm EC (1997) A

2.3. RADIOGRAPHIC IMAGE RECEPTORS AND VIEWING FACILITIES

2.3.1. INTRODUCTION

The Criteria of Acceptability and the related suspension/tolerance levels for X-Ray Films,

Screens, Cassettes, CR, DR, Automatic Film Processors, the Dark Room, Light Boxes and

the Environment for general radiography are presented in Tables 2.5 to 2.12 below. They

do not deal with the requirements for mammography or dental radiography.

A wider approach to Quality Assurance of film, film processing and image receptors of all

types is a critical part of an overall day to day quality system (IPEM, 2005a; BIR, 2001,

IPEM, 1997a; Papp, 1998). Such a system includes commissioning. Detailed

commissioning tests are covered in other publications (IPEM, 1997a).

There are some fundamental differences between CR and film/screen systems. Proper

installation and calibration of a CR system in a radiology department is extremely important.

It is also important to note that the x-ray system needs to be properly set up so that it may


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be used with CR plates. In particular, the AEC needs to be appropriately set up (Section

2.2).

Details on desirable specifications and features of CR systems as well as their proper

installation can be found in AAPM Report No 93 (2006a). These guidelines should be

followed prior to the acceptability testing of CR systems. To date, unlike film systems, there

is little guidance on the performance of CR systems, and the suspension/tolerance levels

identified will almost inevitably need adjustment in line with future evidence and guidance

(Section 1.4).

Likewise, with DDR systems, the tube and generator, workstation and /or laser printer must

be known to be working properly. When undertaking the QA of the tube and generator, it is

advisable to keep the detector out of the beam or protected by lead. As with CR little

guidance is available on Suspension/Tolerance levels and the advice given above for CR

prevails. Suspension/ tolerance levels suitable for application at the present time are

provided in Table 2.7.

Display monitors and hardcopy images have a crucial role in the diagnostic process. IPEM

notes that inadequacies in the imaging viewing area may serve to negate the benefits of

other efforts made to maintain quality and consistency. Modern radiology departments

require digital images from many modalities and from PACS systems to be viewed in many

locations. Two classes of display are used: diagnostic (systems used for the interpretation

of medical images) and review (viewing medical images for purposes other than for

providing a medical interpretation). The requirements for each are different.


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2.3.2. CRITERIA FOR IMAGE RECEPTORS AND VIEWING FACILITIES

Table 2.5 Criteria of Acceptability for Automatic Film Processors, Films, Screens, Darkrooms

and Illuminators (mammography excluded)

Physical Parameter Suspension

Level

Reference Type Notes

Automatic Film

Processor:

Base plus Fog OD > 0.3 IPEM (2005a)

IPEM (1997a)

B See also IEC 61223-

2-1 (1993c), Papp

(1988) and EC

(1997)

Speed Index 1.2 ± 0.3 IPEM (2005a)

BIR (2001)

IPEM (1997a)


2-1 (1993c) and

Papp (1988).

Contrast Index 1.0 ± 0.3 IPEM (2005a)

BIR (2001)

IPEM (1997a)


2-1 (1993c) and

Papp (1988).

Films, Screens,

Darkroom and

Illuminators:

Screens and

Cassettes

Visible artefacts. IPEM (2005a)

BIR (2001)

IPEM (1997a)


2-2 (1993d) and EC

(1997).

Relative Speed of

Intensifying Screens

> 10% or

> 0.3 OD across

film.

IPEM (2005a)

IPEM (1997a)

B See also EC (1997).

Film Screen Contact Non-uniform

density or loss of

sharpness.

IPEM (1997a) B See also IEC 61223-

2-2 (1993d) and EC

(1997).

Dark Room Safe

Lights and Film

fogging

Evidence of film

fogging after twice

the normal Film

Handling Time.

IPEM (2005a)

BIR (2001)

AAPM (2002)


2-3 (1993e).

Ambient Lighting > 100 Lux. IPEM (1997a) B See also Papp

(1988), EC (1997).


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Table 2.6 Criteria for Acceptability of Cassettes and Image Plates:

Physical Parameter Suspension Level Reference Type Notes

Condition of

cassettes and image

plates

Damage to plate IPEM (2005a) B Suppliers‟

recommendations for

method

Uniformity Gross non-uniformity

Mean ± 20%

IPEM (2005a) B 70kV, 1.0 mm copper

at tube head, an

exposure for 10µGy,

read plate under linear

algorithm.

Table 2.7 Criteria for Acceptability of CR readers see notes 1 and 2


Dark Noise

Agfa SAL>130

Fuji pixel value > 280

Kodak EIGP > 80

Kodak EIHR > 380

Konica pixel value <

3975

AAPM (2006a)

B Erase plates, leave

plates 5 minutes, read

under standard

conditions.

Repeat for all plate

sizes.

Linearity and system

transfer properties

Manufacturer‟s

specification

KCARE (2005a) B KCARE CR QA.

Establish system

transfer properties

equation (STP)

Dose=f(pixel value)

Erasure cycle

efficiency

Blocker visible in

second image

IPEM (2005a) B High attenuation

material

Exposure index

consistency

Indicated exposure

does not agree with

measured exposure

within 20%

KCARE (2005a) B Record detector dose

indicator and calculate

indicated exposure

using the STP equation

for all plates

Detector dose

indicator consistency

The variation in the

calculated indicated

exposures differs by

greater than 20%

between plates for a

same exposure

KCARE (2005a) B

Scaling errors > 2% IPEM (2005a) B

Blurring Blurring present KCARE (2005a) B Use contact mesh

Image quality High

Contrast Resolution

(Limiting Spatial

Resolution)

Spatial resolution

better than 2.8 lp/mm

for dose < 10 μGy.

≥ 2.4 lp/mm for dose <

5 μGy.

DIN 6868-58

(2001)

A,C Use phantom described

in the standard. Also

note AAPM, 2006a &

Walsh et al. 2008

Contrast All seven steps visible DIN 6868-58

(2001)

A,C Use phantom described

in the standard


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Low-Contrast

Resolution

Manufacturers

specifications

AAPM (2006a)

B Low contrast resolution

test object

Laser beam function Edge not continuous

the full length of the

image

AAPM (2006a)

B Steel ruler

Moiré Patterns Moiré Patterns visible KCARE (2005a) B 70kV, 1.0mm of copper

at tube head, grid in

place, plate in the

bucky at 150cm from

the focus

1. The suspension values quoted for Dark Noise were valid at the time of Publication of this document.

However as CR is an evolving technology they are subject to change.

2. This is a test that has to be done during the acceptance testing of the CR Reader in order to establish

the relationship between receptor dose and pixel value. It tests whether the X-ray generator and the

CR reader have been properly set up in order to work together correctly.


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Table 2.8 Criteria of Acceptability for DDR systems see notes 1, 2

Physical

Parameter

Suspension Level Reference Type Notes

Dark Noise

Excessive noise in the

system

IPEM (2005a ) B Image without

exposure or very low

exposure

Linearity Manufacturers

recommendation

KCARE (2005b) C Establish system

transfer properties

equation (STP)

Dose=f(pixel value)

Image retention Ghosting present KCARE (2005b) C Low exposure with

closed collimators and

detector covered with

lead apron.

Exposure Index Indicated sensitivity

indices differ by greater

than 20% of equivalent

exposure sets.

KCARE (2005b) C 70kV, 1.0 mm copper

at tube head, at least

three times for 10

µGy. Repeat for 1

µGy and 12 µGy

Uniformity

Mean ± 5% IPEM (2005a) B 70kV, 1.0 mm copper

at tube head, 10 µGy.

Scaling errors >2% IPEM (2005a) B Grid, attenuating

object of known

dimensions or lead

ruler

Uniformity of

resolution

Blurring present IPEM (2005a) B Use fine wire mesh

Image quality High

Contrast

Resolution

(Limiting Spatial

Resolution)

Spatial resolution better

than 2.8 lp/mm for dose

< 10 μGy.

≥ 2.4 lp/mm for dose <

5 μGy.

DIN 6868-58

(2001)

A,C Use phantom

described in the

standard. Also note

AAPM (2006a) &

Walsh et al. (2008)

Contrast All seven steps are

visible

DIN 6868-58

(2001)

A,C Use phantom

described in the

standard

1. This test should be done at the acceptance testing of the DDR system in order to establish the relationship between receptor dose and pixel value. This is the relationship between the generator and the detector.

2. It should be noted that a number of manufacturers have installed on their DDR equipment automatic QA software in order to carry out a number of QA tests.


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Table 2.9 Criteria of Acceptability for Diagnostic Monitors


luminance ratio <200 IPEM (2005a)

AAPM (2006a)

B

luminance ratio Black baseline ±35%

White baseline ±30%

IPEM (2005a)

AAPM (2006a)

B

Distance and angle calibration –

distortion (for CRT)

10% IPEM (2005a)

RCR (2002)

SEFM-SEPR (2002)

B

Resolution Visual inspection low

and high contrast

resolution different from

baseline

IPEM (2005a)

AAPM (2006a)

B

DICOM greyscale

(GSDF= DICOM Grayscale

Standard Display Function)

GSDF ±15% IPEM (2005a)

AAPM (2006a)

B

Uniformity >40% IPEM (2005a)

AAPM (2006a)

B

Variation between adjacent

monitors

>40% IPEM (2005a)

AAPM (2006a)

RCR (2002)

B

Room illumination >25 lux IPEM (2005a)

AAPM (2006a)

B


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Table 2.10 Criteria of Acceptability for Printers


Optical density

consistency

Baseline ±0.30 IPEM (2005a)

BIR (2001)

IEC (1994a)

B Note also AAPM

(2006a)

Image uniformity >10% IPEM (2005a)

B Note also AAPM

(2006a)

Table 2.11 Criteria of Acceptability for Film Scanners


Grayscale >10% Halpern (1995)

Lim (1996)

Meeder et al (1995)

Seibert (1999)

Trueblood (1993)

SEFM-SEPR (2002)

C

Image uniformity >10% Halpern (1995)

Lim (1996)

Meeder et al (1995)

Seibert (1999)

Trueblood (1993)

SEFM-SEPR (2002)

C

Distortion >10% Halpern (1995)

Lim (1996)

Meeder et al (1995)

Seibert (1999)

Trueblood (1993)

SEFM-SEPR (2002)

C

Spatial resolution Visual inspection low and

high contrast spatial

resolution different from

baseline

Halpern (1995)

Lim (1996)

Meeder et al (1995)

Seibert (1999)

SEFM-SEPR (2002)

C


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Table 2.12 Criteria of Acceptability for Viewing Boxes


Luminance < 1000 cd/m2

Mammography

< 3,000 cd/m2

> 6,000 cd/m2

IPEM (2005a) B IEC (1993f)

Uniformity >30%

Mammography < 30%

IPEM (2005a) B IEC (1993f)

Variation between adjacent

viewing boxes

>30%

Mammography < 15%

IPEM (2005a) B IEC (1993f)

Room illumination (general

radiography)

>150 lux IPEM (2005a) B IEC (1993f)

Room illumination

(mammography)

>50 lux CEC (2006) A IEC (1993f)

2.4. MAMMOGRAPHY

2.4.1. INTRODUCTION

Mammography involves the radiological examination of the breast using x-rays. Mammography is

primarily used for the detection of breast cancer at an early stage and is widely used in screening

programmes involving healthy populations. It is also used with symptomatic patients. Early

detection of breast cancer in a healthy population places particular demands on the radiological

equipment as high quality images are required at a low dose. Perhaps because of the exacting

demands of mammography, acceptability criteria are particularly well developed (IPEM, 2005b;

CEC, 2006).

Mammography should be performed on equipment designed and dedicated specifically for imaging

breast tissue. Either film/screen or digital detectors may be used. The minimum features of a

mammography unit are described in table 2.13. Table 2.14 summarises the acceptability criteria for

conventional mammography equipment and 2.15 those for digital units.


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Table 2.13 Minimum Specification of an X-ray Unit Designed for mammography

Aspect Specification

X-ray Tube Nominal Focal Spot Broad focus 0.3 (IEC, 2003a)

Small focus 0.15

AEC (Analogue Equipment) Adjustable or automatically adjusted position

Fine control of optical density

Compression Motorized

Readout of compression thickness

Grid Moving (dedicated mammography)

Focus Film Distance ≥ 60cm

2.4.2. MEASUREMENTS

Measurements to assess the performance of mammography units should be performed using a

series of test equipment, some of which are specifically designed for the purpose.

Specific Tests are outlined in the tables below. The purpose of the test and a recommended

protocol are cited, together with alternative acceptable protocols. These should form part of a

quality system (BSI, 1994).


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Table 2.14 Film Screen Mammography


Target Film Density OD<1.3 or >2.1 IPEM (2005a) B

Not correctable

by AEC fine

control

AEC Consistency mAs > ±5% Variation in mAs

< CEC (2006) A

AEC Thickness

Compensation

Maximum deviation in OD ≥

0.15 from value at 4cm of

PMMA or range of ODs >

0.35

CEC (2006)

AFFSAPS

(2007)

A

B

Film/Screen Contact >1 cm² poor contact CEC (2006) A

High Contrast

Resolution < 12lp/mm CEC (2006) A

Threshold Contrast > 1.5% 5-6mm CEC (2006) A

X-ray/Film Alignment > 5mm CEC (2006) A

Compression

Maximum Force > 300N

200N not achievable by

adjustment of manual

control.

CEC (2006)

A

Tube Potential > 2kV difference from set

value. IPEM (2005a) B

HVL See Table 2.16 CEC (2006) A

Compression Force

Consistency > 20N CEC (2006) A In 30S


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Table 2.15 Digital Mammography Systems

Physical

Parameter Suspension Level Reference Type Notes

AEC Consistency mAs>±5% baseline CEC (2006) A

AEC Thickness

Compensation

CNR/PMMA Thickness, with the value at

5cm being used as reference, values at

other thicknesses are 2.0cm >115%

4.5cm >103% 3.0cm >110% 5.0cm >

100% 4.0cm >105% 6.0cm > 95%

7.0cm > 90%

CEC (2006) A

Threshold Contrast > 0.85% 5-6mm > 2.35%

0.5mm > 5.45% 0.25mm CEC (2006) A

X-ray/Film

Alignment >5mm CEC (2006) A

Compression Maximum Force > 300N and

200N not reachable.

IPEM (2005a)

CEC (2006)

B

A

Tube Potential

Accuracy > 2kV difference from set value. IPEM (2005a) B

HVL See Table 2.16 CEC (2006) B

Compression

Force Consistency > 20N CEC (2006) A In 30S

Table 2.16 Typical HVL measurements for different tube voltage and target filter

combinations. (Data includes the effect on measured HVL of attenuation by a PMMA

compression plate*) (CEC, 2006)

HVL (MM Al) for target filter combination

kV Mo +30 m Mo Mo +25 m RH RH +25 m RH W +50 m RH W +0.45 m Al

25 0.33 ± 0.2 0.40 ± .02 0.38 ± .02 0.52 ± .03 0.31 ±.03

28 0.36 ± .02 0.42 ± .02 0.43 ± .02 0.54 ± .03 0.37 ±.03

31 0.39 ± .02 0.44 ± .02 0.48 ± .02 0.56 ± .03 0.42 ± .03

34 0.47 ± .02 0.59 ± .03 0.47 ± .03

37 0.50 ± .02 0.51 ± .03

* Some compression paddles are made of Lexan, the HVL values with this type of compression

plate are 0.01 mm Al lower compared with the values in the table.


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2.5. DENTAL RADIOGRAPHY

2.5.1. INTRODUCTION

Dental radiography, though often delivering a low dose, is the most frequently conducted type of x-

ray examination. This section is applicable to radiographic systems for intra oral radiography using

both film and digital detectors.

2.5.2. INTRA-ORAL SYSTEMS

The following are not acceptable for dental imaging:

- Nominal or actual tube voltage < 60kVp for DC and 65-70Kvp for AC equipment

- Mechanical timers

- Film class lower than E

- Focus skin distance for intra oral equipment < 20cm.

- Non-rectangular collimators

- Systems without audible exposure indication.

Material and results of testing dental equipment are available in Gallagher et al. (2008), EC (1997),

IEC standards, and the criteria for dental equipment adopted by EU member states (Belsuit van het

FANC, 2008; IPEM, 2008; Luxembourg Annexe 7, 2008; JORF, 2007; IEC, 2000a; IPEM, 2005a;

Directive R-08-05, 2005; SEFM-SEPR, 2002).

Where exposure settings or pre-programmed exposure protocols are provided with the equipment,

their appropriateness should be checked as part of the confirmation that the equipment is

acceptable. A distinction should be made between exposure settings for adults and children.


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2.5.3. CRITERIA FOR DENTAL RADIOGRAPHY

Table 2.17 Criteria of Acceptability for Intra-Oral Dental Equipment

Physical parameter Suspension level Reference (type) Type Notes

Film development

Developer temperature <18°C and > 40°C IPEM (2005a)

Luxembourg

Annexe 7 (2008)

B Use

Thermometer

Dark room (or desktop

day light processor)

light proof

Gross fog > 0.3 OD IPEM (2005a) B Densitometer

Reproducibility of gross

fog, speed and contrast

Gross fog > 0.3 OD;

IPEM (2005a) B Densitometer;

X-ray tube and

generator

Tube voltage accuracy Maximum deviation

± 10%

JORF (2007) A kV meter,

Indication of exposure

time

Difference between

measured exposure

time and baseline >

50%

IPEM (2005a)

EC (1997)

A, B Dosimeter

Consistency of

exposure time

EC (1997) A Dosimeter???

Dosimetry

Incident air kerma for

upper molar tooth

Ka > 4mGy JORF (2007)

Luxembourg

Annexe 7 (2008)

A Measurement

of incident air

kerma at the

tip of the

collimator


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2.5.4. PANORAMIC RADIOGRAPHY

This section is applicable to radiographic systems for panoramic dental radiography.

Table 2.18 Criteria for Acceptability of OPG Systems


Image quality

Characteristics of the

panoramic image

Outside manufacturer‟s

specification

D Follow

manufacturer‟s

specifications and

test object

Dosimetry

Kerma area product of a

typical clinical exposure

or calculated kerma

area product from dose

width product or

equivalent

Deviation > 35% of

indicated PKA value.

JORF

(2007)

A KAP meter or

equivalent

dosimeter.

2.5.5. CEPHALOMETRY

This section is applicable to radiographic systems for cephalometry.

In addition, cephalometric systems should:

- have X-ray beams collimated to the detector and not larger than 24cmx30cm

- have at least a distance of 150cm between focus and skin

Table 2.19 Criteria for Acceptability of Cephalometry Systems

Physical parameter Suspension level Reference Type Notes

Dosimetry

Kerma area product of a typical

clinical exposure

PKA > 80 mGycm2 JORF (2007)

Luxembourg

Annexe 7

(2008)

A PKA meter or

equivalent


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2.6. FLUOROSCOPIC SYSTEMS

2.6.1. INTRODUCTION

Fluoroscopic systems can be highly flexible and are open to a wide range of applications.

They may offer a multiplicity of modes (and sub-modes) of operation. A representative

subset of the most probable intended uses of the equipment should be identified for

acceptability testing. For example, the main “cardiac mode(s)” and associated sub-modes

might be tested in a unit whose intended application will be in the area of cardiac imaging.

If the unit is later deployed for different purposes the need for a new acceptability test will

have to be considered by the practitioner and the MPE.

In many cases fluoroscopic systems are supplied as dedicated units suitable for cardiac,

vascular, gastrointestinal or other specific applications. Powerful mobile units are available

and are generally flexible. In all cases the MPE will have to consider the intended

application of the unit and the environment in which it will be installed and used. With

respect to the X-Ray generator, many of the criteria of acceptability are similar to those

prevailing for general radiographic systems.


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2.6.2. CRITERIA FOR ACCEPTABILITY OF FLUOROSCOPY EQUIPMENT

Table 2.18 Criteria of Acceptability for Fluoroscopy and Fluorography Equipment

Physical

Parameter

Suspension Level Reference Type Notes

Mechanical –

Safety

If defects pose an

immediate mechanical

or obvious electrical-

shock (hazard to

patients or staff)

IEC (2003b)

CRCPD (2002)

A 38 cm for fixed

fluoro

30 cm for mobile

fluoro

20 cm for special

surgical fluoro

Collimation Limits Irradiated area > 1.15 ×

imaged area

IEC (2000b)

A Use radiography

Half-value layer Table 2.1 applies IEC (2000b) A Test methods are

modality specific

Patient Air Kerma

Rates, and Image

receptor input Air

Kerma Rates

The four rows BELOW

are SENTINEL

VALUES offered for

consideration

IPEM (2005a, 2002)

Martin et al (1998)

Dowling et al (2008)

O‟Connor et al

(2008)

C The four rows

BELOW are

SENTINEL

VALUES offered for

consideration

“Patient” Entrance

Dose Rate, Fluoro

Mode: (Image

Intensifier and FPD

Systems.)

> 50 mGy/min

> 100 mGy/min

O‟Connor et al

(2008)


C Normal mode

smallest field size.

20 cm water or

equivalent.

Normal mode, any

field size.

Maximum (lead)

“Patient” Entrance

Dose/exposure

Digital Acquisition

Mode (Image

Intensifier and FPD

Systems.)

> 2mGy/exposure.

Cardiac Systems: >

0.2mGy/exposure

O‟Connor et al

(2008)


C IPEM and Martin

protocols. Largest

field size. 20 cm

water or equivalent.

Normal from survey

is 0.03 – 0.12

mGy/exposure)

Detector Entrance

Dose Rate, Fluoro

mode :(Image

Intensifier and FPD

Systems).

> 1 μGy/sec in

continuous fluoroscopy

mode.

Cardiac Systems: >

1μGy/sec in continuous

fluoroscopy mode.

O‟Connor et al

(2008)


C 2 μGy/sec quoted

in IPEM but not

seen in practice.

IPEM protocols.

Largest field size.

Normal mode.

Detector Entrance

Dose/exposure

Digital Acquisition

> 5μGy/exposure.

O‟Connor et al

(2008)


C Normal from survey

0.06 – 0.2

μGy/exposure


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Mode :(Image

Intensifier and FPD

Systems.)

Cardiac Systems:

>0.5μGy/exposure.

IPEM protocols.

Largest field size.

Integrated “dose

meter” calibration

If absolute accuracy

> ±35 %

IEC (2000b)

A

High contrast

resolution and

focal-spot

Spatial Resolution: < 1

lp/mm.

For Cardiac Systems: <

1.2 lp/mm

IPEM (2005a)

B Largest Field Size.

Low contrast

detectability

Threshold Contrast: >

4%

IPEM (2005a)

B

Largest Field Size.

Systems or modes

of operation

controlled by

manually setting X-

ray factors

Radiographic generator

output conditions.

As above for High

Contrast resolution and

low-contrast

detectability.

See also Section 2.2 A

Fluoroscopic Timer Acoustic alert is not

functional or not

continuous until reset.

See also Section 2.2 A

2.7. COMPUTED TOMOGRAPHY

2.7.1. INTRODUCTION

CT examinations are among the highest dose procedures encountered routinely in

diagnostic radiology and account for up to 70 percent of diagnostic medical irradiation.

Thus it is important both in terms of individual examinations and population effects. The

design and proper functioning, and particularly the optimal use of equipment can

substantially influence CT dose. This can be particularly important when pregnant patients

or children are involved. CT scanners are under continual technical development resulting

in increasing clinical application (Nagel, 2002). In the last two decades the development of

helical and multidetector scanning modes allowed greatly enhanced technical abilities and

clinical application (Kalender, 2000).

CT scanners may be replaced for reasons that, in theory, include poor equipment

performance as demonstrated by failure to meet acceptability criteria. In practice it is also

likely that replacement may frequently be with a view to meeting increased demands on the

service, or to take advantage of new developments which enable improved diagnostics,


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faster throughput or other clinical benefits. In practice there are few (if any) examples of CT

scanners being removed from use on the basis of their failure to meet currently accepted

criteria of acceptability. This suggests that these criteria are ineffective or that

obsolescence due to rapid technological development can be an overwhelming

consideration in equipment replacement. Arising from these observations it is possible that

the available criteria, including those which follow, should be viewed with caution. A review

of the dose parameters or dose to patients for certain key procedures, and their comparison

to accepted diagnostic reference levels, is a more meaningful measure of the acceptability

of the practice using the CT scanner, but this is outside of the scope of the current

document.

CT scanners are increasingly utilised in radiotherapy in support of treatment planning

(Mutic, 2003; IPEM, 1999). They are also a component of PET-CT systems and CT

acceptability criteria can be applied to the CT component.


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2.7.2. CRITERIA FOR ACCEPTABILITY OF CT SYSTEMS

Table 2.19 Criteria of acceptability for CT Equipment see notes 1-3

1 Protocols either programmed in lookup table or in written form.

2 MPE should compare procedure dose levels with appropriate DRLs

3 applicable for equipment manufactured after 2001

4 Protocols are programmed in lookup table or in written form

5 MPE should compare procedure dose levels with appropriate diagnostic reference levels


CTDI, DLP /CVOL,

CW, PK.L,CT

Dose ± 20% of

manufacturer's

specifications;

IEC (2004a) A

Accessible

protocols4

should be

consistent with

good practice5

ESPECIALLY for

paediatrics.

Accuracy of indicated

dose parameters

Dose ± 20%

indicated dose A

Image noise Noise ± 25 % of

baseline. IPEM (2005a) B

Uniformity ±8 HU

CEC (2006)

B

Value

recommended in

IEC (2004a) is ±4

HU

CT number accuracy

CT number ± 20 HU

(water); ± 30 HU

(other material)

compared to baseline

values

IPEM (2005a) A

(French

standards are ±4

HU nominal or

baseline)

Artefact D

Any artefact

likely to impact

on clinical

diagnosis

Image Display and

Printing See section 2.3

Image slice width

+ 0.5 mm for <1

mm ; ±50% for 1 to

2 mm; ± 1mm

above 2 mm.

IEC (2004a) A


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2.8. DUAL ENERGY X-RAY ABSORPTIOMETRY

2.8.1. INTRODUCTION

Dual-energy X-ray Absorptiometry (DXA) is primarily used in determination of bone mineral

density; however its application has more recently been extended to include estimates of

body fat content. It is performed on equipment specifically designed for and dedicated to

these purposes. Similar examinations are performed on CT with much higher doses

(Kalender, 1995).

For comparison of scanner results and longitudinal studies the accuracy of calibration is

critical. The effect of software updates also needs to be monitored. However there are well

documented discrepancies between the results obtained on the scanners of major

manufacturers (Kelly, Slovik and Neer, 1989). Further work in this area is essential.

2.8.2. ACCEPTABILITY CRITERIA FOR DXA SYSTEMS

Table 2.20 Criteria of Acceptability for DXA Equipment


Patient Entrance

Dose

Less than 500 μGv for

spine examination.

Outside +/- 50%

deviation from

manufacturers

specified nominal

patient dose

Larkin et al (2008)

Njeh et al (1999)

Sheahan (2005)

C Normal from

survey is 20 –

200 μGv)

Clinical Protocol –

standard.

Worst case 35%

from Larkin paper

and 40% from

Sheahan paper.

Repeatability of

Exposures

See Section 2.2

BMD accuracy Outside 3% of

manufacturer‟s

specified BMD

Larkin et al (2008)

Sheahan (2005)

BIR (2001)

IAEA (2009)

Sheahan et al

(2005)

C Standard protocol

with supplier‟s

phantom.


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3. NUCLEAR MEDICINE EQUIPMENT




3.1. INTRODUCTION

The safe, efficient and efficacious practice of nuclear medicine involves the integration of a

number of processes. The quality of each process will have an impact on the overall quality

of the clinical procedure and ultimately on the benefit to the patient. It is important,

therefore, that each process be conducted within the framework of a quality assurance

programme that, if followed, can be shown to achieve the desired objectives with the

desired accuracy.

The levels of activity in radiopharmaceuticals to be administered clinically are governed

primarily by the need to balance the effectiveness and the safety of the medical procedure

by choosing the minimum absorbed dose delivered to the patient to achieve the required

objective i.e. diagnostic image quality or therapeutic outcome. To realize this goal, it is

important to keep in mind that a nuclear medicine procedure consists of several

components, all of which must be controlled in order to have an optimal outcome.

Although the quality assurance of radiopharmaceuticals is an important process (IAEA,

2006), it is not an objective of this section. However, the performance testing of the

equipment needed to carry out the quality assurance of radiopharmaceuticals is an

objective, both for therapeutic and diagnostic procedures. Devices are included for the

determination of administered dose and radiochemical purity such as activity measurement

instruments (activity meter or dose calibrator), gamma counter, thin layer chromatography

scanner and high performance liquid chromatography radioactivity detector.

More specifically the objective of this section is to specify acceptable performance tolerance

levels (suspension levels) for the equipment used in Nuclear Medicine procedures, both for

gamma camera and positron emission based procedures. In-vitro Nuclear Medicine


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diagnostic equipment and instruments are not covered since these do not contribute to the

patient exposure.

Some Positron Emission Tomography Installations have in-house production of the

radiopharmaceuticals they use (e.g. FDG labelled with 18F), utilising either self-shielded

cyclotrons or cyclotrons placed in specially designed bunkers. This activity is regarded as a

radiopharmaceutical manufacturing activity and therefore is outside the scope of this report.

This section also covers the instruments needed for therapeutic procedures and intra-

operative probes, since these are used directly on the patient to trace the administered

radioactivity.

When equipment no longer meets the required performance specifications (suspension

levels), it should be withdrawn from use, may be disposed of, and replaced (Article 8 (3) of

Council Directive 97/43/Euratom). Alternatively, following a documented risk assessment

involving the MPE and the Physician, equipment may be used for less demanding tasks for

which a lower specification of performance is acceptable. The operator must be advised of

the circumstances.

The suspension levels stated are intended to assist in the decision making process

regarding the need for recalibration, maintenance or removal from use of the equipment

considered.

This section considers equipment used for:

1 Nuclear medicine therapeutic procedures

2 Radiopharmacy quality assurance programme

3 Gamma camera based diagnostic procedures

4 Positron emission diagnostic procedures

5 Hybrid diagnostic systems

6 Intra-operative probes


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Each part of this section is comprised of a brief introduction and a list of relevant

equipment. For each piece of equipment, a brief introduction, a table with the critical

performance parameters and the suspension levels are given. References to recommended

test methods for each parameter are also given.

3.2. NUCLEAR MEDICINE THERAPEUTIC PROCEDURES

3.2.1. INTRODUCTION

Unsealed radioactive sources are administered to patients orally, intravenously or injected

into various parts of the body for curative or palliation purposes. The management of the

patient depends on the activity and radionuclide used to give the prescribed absorbed dose.

It may be necessary for the patient to be confined into a specially designed room for a few

days before being released from the hospital to provide radiation protection to hospital staff

and members of the public.

When working with unsealed radioactive sources, contamination always presents a

potential hazard. Such contamination may come from persons working with the radioactive

sources or from patients who have been treated with these substances. Such

contamination presents a hazard to anybody coming into contact with it and should be

avoided if at all possible, monitored and controlled if it occurs.

The patient undergoing treatment with unsealed radioactive sources must also be checked

before he/she is released from hospital to determine that the dose rate from his/her body is

down to acceptable levels for members of the public.

Three types of equipment that are used in Nuclear Medicine therapeutic procedures are

considered in this part. These are:

Activity measurement instruments

Contamination monitors

Patient dose rate measuring instruments


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3.2.2. ACTIVITY MEASUREMENT INSTRUMENTS

Many different radionuclides are used for Nuclear Medicine therapeutic procedures. The

amount of activity to be administered to the patient must be determined accurately. Activity

measurement instruments, commonly known as Isotope Calibrators or Dose Calibrators,

must be capable of measuring the activity of a particular radionuclide (gamma or beta

emitting) accurately over a wide range of energies for correct determination of the patient

dose. They must also be capable of measuring accurately over a wide range of activities.

The performance of activity measurement instruments must be assured through a quality

assurance programme conforming to international standards (IEC, 1994c; IEC, 2006). The

suspension levels are given in Table 3.1 for each critical parameter together with the type of

criterion used and a reference to a recommended test method.

Table 3.1 Suspension Levels for Activity Measurement Instruments


Background response > 1.5 X Usual

Background

IEC (2006) (section 4.1)

IEC (1994c) (section 8)

C

Constancy of instrument

response

± 10% IEC (2006) (section 4.2) C

Instrument Accuracy ± 10% IEC (1994c) (section 3) C

Instrument Linearity ± 10% IEC (2006) (section 4.3)


C

System reproducibility ± 10% IEC (1994c) (section 5) C

Sample volume characteristics ± 15% IEC (1994c) (section 7) C

Long-term reproducibility ± 10% IEC (1994c) (section 9) C

The suspension levels given in the above table are for instruments used for the

measurement of the activity of gamma emitting sources with energies above 100keV. If

these instruments are calibrated to measure low gamma ray energies (below 100 keV),

beta or alpha emitting sources (Siegel et al, 2004) and the instrument is suspected of

malfunctioning then a test with a relevant source needs to be carried out to confirm the

suspicion using the values in the above table.

3.2.3. CONTAMINATION MONITORS

The contamination monitor (also called area survey meter) is designed for the detection and

measurement of radioactivity (alpha, beta and gamma) on the surface of objects, clothing,


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persons etc. It is used wherever contamination by radioactive substances may be

encountered and has to be monitored routinely.

The determination of a monitor‟s (instrument‟s) performance can be at different levels of

complexity (ICRU, 1992). A more detailed level is required for the evaluation or type testing

of a particular monitor design. Once the monitor has been type tested, less extensive

procedures can be used to establish either that a given monitor has maintained its

calibration or that it has the same characteristics as the original type tested monitor (IEMA,

2004; IPSM, 1994). The complexity of the procedure depends on what information is

required and is generally intermediate between that required by a full type test and a simple

reproducibility check.

The suspension levels are given in Table 3.2 for each critical parameter of contamination

monitors together with the type of criterion used and the reference to a recommended test

method.

Table 3.2 Suspension Levels for Contamination Monitors


Sensitivity > 1.2 X Usual Background IEC (2001a) (section 4.2) B

Monitor Linearity ± 20% IPSM (1994) (section 3.3)



B

Statistical Fluctuation of

Reading

± 20% IPSM (1994) (section 3.4) B

Monitor Response Time ± 10% IPSM (1994) (section 3.5) B

Energy Dependence of

Monitor

± 20% IPSM (1994) (section 3.6) B

There is a large variation between the different types of contamination monitors. The above

suspension levels are a compromise and in some cases may be considered as too

conservative.

3.2.4. PATIENT DOSE RATE MEASURING INSTRUMENTS

A patient who has been administered with a therapeutic amount of activity of a radionuclide

becomes a radioactive source and may need to be confined in a specially designed room

for a few days before being safe to be released from hospital. The monitoring of the patient


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dose rate is very important when gamma radiation is being emitted that can irradiate other

persons at a distance from the patient. Therefore, the gamma dose rate of the patient is

measured at a standard distance and should be below the acceptable level before the

patient is released from hospital.

The performance of a patient dose rate measuring instrument must be assured through a

continuous quality assurance programme conforming to international standards (IEMA,

2004) and other commonly acceptable reports (ICRU, 1992; IPSM, 1994). The suspension

levels are given in Table 3.3 for each critical parameter.

Table 3.3 Suspension Levels for Patient Dose Rate Measuring Instruments


Instrument Dose Rate

Linearity

± 20% IPSM (1994) (section 3.3)



C


Reading

± 20% IPSM (1994) (section 3.4) C


Response Time

± 10% IPSM (1994) (section 3.5) C


Instrument

± 20% IPSM (1994) (section 3.6) C

There is a large variation between the different types of patient dose rate measuring

instruments. The above suspension levels are a compromise and in some cases may be

considered as too conservative.

3.2.5. RADIOPHARMACY QUALITY ASSURANCE PROGRAMME

The quality of the radiopharmaceutical administered to the patient has to be such that it will

not cause adverse effects to the patient, expose the patient to unnecessary radiation and at

the same time be specific for the organ of interest. As the injected radiopharmaceutical

circulates in the blood system before it is absorbed and preferentially concentrated in the

target organ/tissue, other organs/tissues of the body absorb some of the

radiopharmaceutical and therefore receive an absorbed dose related to the amount of

radiopharmaceutical. Penetrating radiation from the target organ/tissue also irradiate other

organs/tissues. Therefore, the maximum amount administered should not exceed the


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recommended local Derived Reference Levels (DRLs). Poor radiochemical purity will also

result in radioactivity going to non-target organs and irradiate them unnecessarily.

Also different radiopharmaceuticals are used depending on the imaging modality used (PET

or SPECT). Furthermore, for a specific examination there may be more than one

radiopharmaceutical that can be used to acquire the final image.

Taking the above into consideration the administered activity to the patient must be

prepared in a specially designed room, the radiopharmacy (also called the Hot Laboratory),

under a strictly controlled written procedure. The performance of the instruments used in

the preparation must be assured under a quality control programme.

The type and number of instruments required in a radiopharmacy will depend on the

number of modalities available in a Nuclear Medicine Department and the variety of

radiopharmaceuticals and procedures used. For simplicity these are divided into two

categories:

1. Radiopharmacy for gamma camera based diagnostic procedures

2. Radiopharmacy for positron emission based diagnostic procedures

In cases were both gamma camera based and positron emission modalities are available,

the radiopharmacy will need to have instruments capable for accommodating both types of

radiopharmaceuticals, either in a single instrument or different instruments for each type.

3.3. RADIOPHARMACY FOR GAMMA CAMERA BASED DIAGNOSTIC PROCEDURES

3.3.1. INTRODUCTION

The objective of this part is to define suspension levels for the performance parameters of

the equipment needed to carry out the quality assurance programme for

radiopharmaceuticals used with gamma camera based modalities. These include devices

used for radiochemical purity determination such as the activity measurement instrument,

the gamma counter and the thin layer chromatography scanner.

The availability of the above equipment in a radiopharmacy depends on the level and

sophistication of its activities.


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For the protection of the personnel working in a radiopharmacy, instruments such as

contamination monitors are also essential. Therefore this part considers the following

instruments:

Activity Measurement Instruments

Gamma Counters

Thin Layer Chromatography Scanners

Contamination Monitors

3.3.2. ACTIVITY MEASUREMENT INSTRUMENTS

The activity measurement instruments that are used for gamma camera based diagnostic

procedures need to cover the energy range and activity range of the radiopharmaceuticals

that are used in the particular department. The quality assurance programme that must be

followed to assure their performance, as well as the suspension levels are the same as

those described in section 3.2.2, under “Activity measurement instruments”.

3.3.3. GAMMA COUNTERS

These are single “well type” gamma counters used in the radiopharmacy to measure the

activity (number of counts per second) on the paper chromatography strips used for the

radiochemical purity testing of radiopharmaceuticals. These are similar to gamma counters

for in-vitro diagnostic investigations and are used to compare the number of counts of the

different sections of the paper chromatography strips.

The performance of a gamma counter must be assured through a continuous quality

assurance programme conforming to international standards (IEC, 2009) and other

commonly accepted reports (ICRU, 1992; IPSM, 1994). The suspension levels are given in

Table 3.4 for each critical parameter of a well type gamma counter.


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Table 3.4 Suspension Levels for Well Type Gamma Counters


Sensitivity > 1.5 X Usual

Background

IEC (2001a) (section 4.2) C


Linearity

± 20% IPSM (1994) (section 3.3)



C


Reading

± 20% IPSM (1994) (section 3.4) C


Response Time

± 10% IPSM (1994) (section 3.5) C


Instrument

± 20% IPSM (1994) (section 3.6) C

Sample Volume

Characteristics

± 15% IEC (1994c) (section 7) C

The above suspension levels are a compromise and in some cases may be considered as

too conservative.

Test methods that can be used to monitor a gamma counter are similar to those of patient

dose rate measuring instruments. The test method for sensitivity is similar to that of

contamination monitors. The test method for volume dependence of the well type gamma

counters is similar to that of the activity measurement instruments.

3.3.4. THIN LAYER CHROMATOGRAPHY SCANNERS

A thin layer chromatography scanner is a gamma counter that simultaneously measures or

scans the length of the paper chromatography strip and calculates automatically the count

ratio as a measure of radiochemical purity.

The suspension levels of each critical parameter of a thin layer chromatography scanner

are similar to those of a gamma counter (Table 3.4).

3.3.5. CONTAMINATION MONITORS

The contamination monitors usually encountered in a radiopharmacy take the form of

continuous room monitors for air borne contamination and for the contamination of hands

and clothes of the personnel working in the radiopharmacy. The quality assurance


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programme that must be followed to assure their performance is the same as that

described for contamination monitors (see section 3.2.3).

3.4. RADIOPHARMACY FOR POSITRON EMISSION BASED DIAGNOSTIC

PROCEDURES

The specific radioactivity of the radiopharmaceutical is an important factor to consider in

guaranteeing the quality of a PET study (Nakao et al, 2006). Chemical impurities in

radiopharmaceuticals, such as precursors and analogues contained in the preparation, may

interfere with the PET study (and may cause adverse reactions in the patient). Therefore it

is necessary to measure the specific activity and chemical impurities accurately before

administration.

Due to the very short half-lives of PET radionuclides, quality control is carried out by their

producer and they are delivered to the hospital ready for patient administration.

The instruments usually found in a hospital PET radiopharmacy are the same as those for

gamma camera based diagnostic procedure radiopharmacy (Section 3.3.1), calibrated for

the specific PET radionuclides used in a particular hospital. Additionally, in hospital

research departments, one may find instruments such as High Performance Liquid

Chromatography (HPLC), Gas Chromatography (GC) and Thin Layer Chromatography

(TLC) that are used to verify the specific activity, the radiochemical and chemical purity of

the radiopharmaceutical used (Dietzel, 2003). There are also all-in-one instrument that

perform these analyses at the same time. These analysers need to meet Good

Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulation criteria

(OECD, FDA) (Dietzel, 2003).

Currently there are no commonly acceptable suspension levels for such instruments and

therefore the manufacturer‟s recommendations for each specific instrument should be used.

3.3 GAMMA CAMERA BASED DIAGNOSTIC PROCEDURES

3.3.1 INTRODUCTION

The gamma camera is currently available in a number of configurations capable not only of

performing simple Planar Imaging (Section 3.4.2) but also of Whole Body Imaging (Section


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3.4.3) and Single Photon Emission Computed Tomography (SPECT) (Section 3.4.4). Some

dual headed Gamma Cameras with appropriate coincidence circuits and software are also

capable of performing Positron Emission Tomography (Section 3.4.5). However, the PET

Scanner dealt with in section 3.5 is rapidly replacing such systems.

The IEC (IEC, 2005c; IEC, 2004b, 1998b, c) and the National Electrical Manufacturers

Association (NEMA) (NEMA, 2007a, b) in the USA have published relevant standards.

These are almost identical with respect to many test procedures, test objects and

radioactive sources and have been used extensively. The IEC and NEMA standards were

aimed primarily at manufacturers but are now more orientated towards user application

than previous publications making it easier to test for compliance in the field. The NEMA

Standard also includes directions for the testing of Gamma Cameras with discrete Pixel

Detectors. In this section the suspension levels are mainly related to manufacturer‟s

specifications, Type A Criteria. The NEMA standards require that the system “meet or

exceed” the manufacturer‟s specification unless the specification is considered “typical

performance”. “Typical” specifications are used when the measurement is sufficiently time-

consuming that measuring large numbers of units is difficult. For these tests greater

suspension levels have been proposed.

In addition to the standards, there are a number of publications on quality control that

provide a wealth of useful background material and detailed accounts of test methods and

phantoms for routine assessment which must be undertaken on a regular basis according

to national protocols (IPEM, 2003b; AAPM, 1995).

3.4.1. PLANAR GAMMA CAMERA

Gamma cameras are normally operated with collimators appropriate to the study being

performed. Tests performed with collimators in situ are termed „system‟ tests. Tests

performed without collimators are „intrinsic‟ tests. Since there is a large range of different

types of collimator in use and their characteristics vary from type to type and from

manufacturer to manufacturer, professional judgement may have to be called on with

respect to system tests for a particular collimator. It is important to perform system non-

uniformity tests on all collimators in clinical use in order to detect collimator damage at the

earliest opportunity (IEC, 2005b)


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Table 3.5 Suspension Levels for Planar Gamma Systems


Intrinsic Spatial

Resolution

>1.05 times the

manufacturer‟s

specification

IEC (2005a), Section 4.5

NEMA (2007a), Sections 2.1 and 2.7

A

Intrinsic Spatial Non-

Linearity

>1.05 times the

manufacturer‟s

specification


NEMA (2007a) Sections 2.2 and 2.7

A

Intrinsic Non-uniformity >1.05 times the

manufacturer‟s

specification



A

Intrinsic energy

resolution

>1.05 times the

manufacturer‟s

specification


NEMA (2007a), Section 2.3

A

Multiple window spatial

registration

>1.05 times the

manufacturer‟s

specification



A

Intrinsic count rate

performance in air

<0.9 times the

manufacturer‟s

specification

NEMA (2007a), Section 2.6 A

System Spatial

Resolution with scatter

>1.05 times the

manufacturer‟s

specification



A

System Non-uniformity >1.05 times the

manufacturer‟s

specification

IEC (2005a), Section 4.5 A

3.4.2. WHOLE BODY IMAGING SYSTEM

The IEC 61675-3 standard (IEC, 1998c) and the NEMA Standard NU-1 (NEMA, 2007a)

contain a limited number of tests for Whole Body Systems. Before performing these specific

tests, it is advisable that the basic tests for the Planar Gamma Camera are performed for

each detector head used for whole body imaging (Table 3.5).


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Table 3.6 Suspension Levels for Whole Body Imaging Systems


Whole body non-

uniformity

>10% difference between this

and planar system uniformity

IPEM (2003b) Section 4.2.1 B

Whole Body Spatial

Resolution Without

Scatter

>1.05 times the

manufacturer‟s specification

IEC (1998c), Section 3.2


A

Scanning constancy Any deviation in mean count

rate greater than expected

from Poisson statistics

IEC (1998c), Section 3.1 A

3.4.3. SPECT SYSTEM

The IEC 61675-3 standard (IEC, 1998c) and the NEMA Standard NU-1 (NEMA, 2007a)

both contain a section devoted to SPECT systems. The basic tests for Planar Gamma

Camera systems should be performed on each detector head used for SPECT before

commencing with the tests specific for SPECT.


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Table 3.7 Suspension Levels for SPECT Systems


Centre of Rotation

(COR) and Detector

Head Tilt

COR X axis offset:

>1.05 times the

manufacturer‟s

specification

For Multiple head

systems offsets >5%

Mismatch Y axis >5%

between detectors

IEC (2004d), (1998b), Sections 3.1.1

and 3.1.2


IAEA (2007c) Section 4.3.3

IPEM (2003b) Section 5.3.2

A

Collimator Hole

Misalignment

>1.05 times the

manufacturer‟s

specification

IEC (2004d), (1998b), Section 3.2

IAEA (2007c), Section 3.3.6


A

SPECT System Spatial

Resolution

>1.05 times the

manufacturer‟s

specification

IEC (2004d), (1998b), Section 3.6


A

Detector to Detector

Sensitivity Variation

>1.1 times the

manufacturer‟s

specification

NEMA (2007a), Section 4.5 A

Variation of Response

with Detector Rotation

≥1.5% AAPM (1995), Section III.A.1


A

3.4.4. GAMMA CAMERAS USED FOR COINCIDENCE IMAGING

The basic tests for Planar Gamma Camera Systems should be performed on each detector

(Table 3.5). However, the thicker crystals required for these cameras do not perform as well

with respect to intrinsic spatial resolution as the thinner crystals intended mainly for use with

technetium-99m based radiopharmaceuticals (Table 3.8). Tolerances for the other tests are

the same as those in Table 3.6.


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Table 3.8 Suspension Levels for Coincidence Gamma Camera Systems


Intrinsic Spatial

Resolution

>1.05 times the

manufacturer‟s

specification [A]



A

System Spatial

Resolution

>1.05 times the

manufacturer‟s

specification [A]


NEMA (2007), Section 3.2

A

3.5. POSITRON EMISSION DIAGNOSTIC PROCEDURES

3.5.1. INTRODUCTION

Positron Emission Tomography (PET) is a nuclear medicine imaging technique that utilises

positron-emitting radionuclides, normally produced in a cyclotron. The most frequent clinical

indication for a PET scan today is in the diagnosis, staging, and monitoring of malignant

tumours. Other indications include assessment of neurological and cardiological disorders.

The PET technology has evolved rapidly in the past decade. Two significant advances have

greatly improved the accuracy of PET imaging:

(i) the introduction of faster scintillation crystals and electronics which permit higher

data acquisition rates, and,

(ii) the combination, in a single unit, of PET and CT scanners (“hybrid” scanners, see

section 3.6).

It is expected that the utilisation of PET will increase dramatically in the future. In some

cases it may substitute for current nuclear medicine investigations but, in general, PET will

be complementary to the use of single photon imaging with the gamma camera.

The purpose of this section is to specify Suspension levels for PET scanners to be used in

clinical imaging. Note that these technical requirements relate to clinical facilities and are

not intended to apply to research installations.


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3.5.2. POSITRON EMISSION TOMOGRAPHY SYSTEM

PET is based on the coincidence detection of two oppositely directed 511 keV photons

emitted from the annihilation of a positron with an atomic electron in vivo. The detection of

such events, known as true coincidences, is used for the reconstruction of an image

describing the in vivo distribution of a positron emitting radiopharmaceutical. Apart from

these events, there are also other types of erroneous coincidences that may be detected,

namely scattered and random coincidences. Scattered coincidences are events formed by

detection of two annihilation photons, where at least one has undergone Compton

scattering before detection (but still are detected in the energy window), while random

coincidences are formed when two photons originating from two different annihilation sites

are detected within the system‟s coincidence time window.

The performance of PET systems must be assured through a continuous quality assurance

programme conforming to international standards (IEC, 2008c; NEMA, 2007b; IEC, 2005)

and other commonly accepted reports (IAEA, 2009). The suspension levels are based on

Type A Criteria. These are given in Table 3.9 for each critical parameter of PET systems.


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Table 3.9 Suspension Levels for PET Systems


Spatial Resolution FWHMobserved

>1.05*FWHMexpected

NEMA (2007b) (section 3.3) A

Sensitivity

STOT observed < 0.95*STOT expected

NEMA (2007b) (section 5.3)

IEC (2008d) (section 3.3)

IEC (2005b) (section 4.2)

A

Energy resolution REobserved > 1.05*REexpected IAEA (2007c) (section

4.1.4)

A

Scatter fraction, count

losses and random

measurements

NECobserved <NEC Recommended

SFobserved > 1.05*SFexpected

NEMA (2007b) (section 4.3)

IEC (2008d) (section 3.6)

IAEA (2007c) (section

4.1.3)

A

A

Uniformity %NUobserved >

1.05*%NUexpected

NEMA (2007b) (section 7.3) A

Image quality and

accuracy of attenuation

and scatter correction

Unacceptable visual

assessment

IAEA (2007c) (section

5.1.4)

A

Coincidence timing

resolution (TOF)

RTobserved > 1.05*RTexpected IAEA (2007c) (section

4.1.6)

A

Mechanical Tests If any mechanical part is

found to compromise the

safety of operation

C

* Expected and recommended values are the values for each parameter measured or agreed

during the acceptance testing.

FWHM = Full Width at Half Maximum

3.5.3. HYBRID DIAGNOSTIC SYSTEMS

A hybrid diagnostic system is defined as the combination of two diagnostic modalities into

one system. Examples of such systems are PET-CT, SPECT-CT, PET-MRI, etc. Usually

one modality presents functional (molecular) images and the other anatomic images. The

fusion (combination) of their images gives a higher diagnostic value than the individual

images alone.

The quality control procedures of each individual modality comprising the hybrid system are

well established and if followed as recommended, the hybrid system will operate optimally.

The suspension levels for the individual modalities are valid for the hybrid systems as well.

The only concern with hybrid systems even today, is the alignment of the imaging

modalities of the hybrid system. Here it is recommended that an independent alignment


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test, using a phantom in the place of a patient, be used at regular intervals to assure the

alignment of the modalities comprising the hybrid system (NEMA, 2007b; Nookala, 2001).

The suspension level is based on Type C Criteria and is given in Table 3.10 for the

alignment of a hybrid system.

Table 3.10 Suspension Level for the Alignment of Hybrid Systems


Alignment Test of a

Hybrid System

> ± 1 pixel or ± 1

mm, whichever is

bigger

Nookala (2001)

C

3.4 INTRA-OPERATIVE PROBES

Radiotracer techniques using intra-operative gamma probes are procedures that surgeons

can use to more easily localise small tumours or lymph nodes to be removed in a surgical

procedure. Use of intra-operative probes decreases operating time, decreases patient

morbidity and improves staging accuracy. All of these can lead to improved treatment,

improved quality of life and higher long-term survival rates (Halkar and Aarsvold, 1999).

The most established type of intra-operative probe is the non-imaging gamma probe. Other

types such as imaging intra-operative probes and beta probes are less well established or

are still under development and therefore their performance parameters are less rigorously

defined. Furthermore a wide range of gamma probe systems are commercially available

with different detector material, detector sizes and collimator abilities. Various methods of

evaluation of such equipment have been proposed (NEMA, 2004; IEC, 2001a). For these

reasons suspension levels to cover all the types of intra-operative probes do not exist.

For the most common application, that of the detection of the sentinel lymph node (SLN),

minimum requirements of a gamma probe system has been recommended (Wengenmair

and Kopp, 2005; Yu et al, 2005). These were derived mainly from comparison studies of

commercially available probe systems and are presented in Table 3.11. It is recommended

that the user of a particular probe system establish a quality assurance system for the

probe system in use and establish suspension levels taking into account the manufacturer‟s

recommendations.


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Table 3.11 Suspension Levels for a SLN intra-operative gamma probe system

Physical

Parameter

Suspension Level Reference Type

Radial Sensitivity

(far field)

FWHM > 40o Wengenmair and Kopp (2005)

NEMA (2004) (section 3.9)

C

Spatial Resolution FWHM >15mm for

lymph nodes in head,

neck and

supraclavicular

region

FWHM > 20mm for

lymph nodes in

extremities, axilla and

groin

Wengenmair and Kopp (2005)

NEMA (2004) (section 3.5)

C

Sensitivity < 5.5 cps/kBq Wengenmair and Kopp (2005)

NEMA (2004) (section 3.1 – 3.4)

C

Shielding > 0,1 of minimum

system sensitivity

Wengenmair and Kopp (2005) C


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4 RADIOTHERAPY




3.6. INTRODUCTION

The purpose of this document is to list performance parameters and their tolerances.

Specific reference is not made to safety requirements, but these need to be checked at

acceptance and after maintenance and upgrades and may result in suspension of the

equipment during operation, if not met.

These functional performance tolerances reflect the need for precision in radiotherapy and

the knowledge of what can be reliably achieved with radiotherapy equipment. The

tolerances presented must be used as suspension levels at which investigation must be

initiated, according to the definition in section 1.4.2. Where possible, it will be necessary to

adjust the equipment to bring the performance back within tolerance limits. If adjustment is

not possible, e.g. loss of isocentric accuracy, it may still be justified to use the equipment

clinically for less demanding treatments. Such a decision can only be taken after careful

consideration by the clinical team (responsible medical physics expert and radiation

oncologist) and must be documented as part of an agreed hospital policy. Alternatively it

should be suspended from use until performance is restored. Suspension from use can also

be required if the safety requirements in the relevant safety standards are not met.

In the following clauses these levels are referred to as performance tolerance levels, as this

is the terminology used in the quoted IEC standards. However, in the tables these levels

are listed as tolerance/suspension levels as they correspond also with the definition of

suspension level in section 1.4.2 and used in the other sections of this document.

The performance tolerance/suspension levels quoted in this section have been extracted

mostly from international and national standards (category type A), supplemented by

guidance from national professional bodies (category type B) (see section 1.4.3).

Tolerances are expressed in the same format (e.g. ± or maximum deviation) as originally

given in the quoted standards and guidance documents.


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All test equipment used in measuring functional performance must be well maintained,

regularly calibrated and traceable (where appropriate) to national standard laboratories.

3.3 LINEAR ACCELERATORS

IEC 60601-2-1 (1998a) is the standard which identifies those features of design that are

regarded as essential for the safe operation of the equipment and places limits on the

degradation on the performance beyond which a fault condition exists. These include

protection against electrical and mechanical hazards and unwanted and excessive radiation

hazards (i.e. dose monitoring systems, selection and display of treatment related

parameters, leakage radiation and stray radiation).

IEC 60976 (2007) and IEC 60977 (2008c) are closely related to this standard. The former

specifies test methods and reporting formats for performance tests of medical electron

accelerators for use in radiotherapy, with the aim of providing uniform methods of doing so.

The latter is not a standard per se but suggests performance values, measured by the

methods specified in IEC 60976 (2007) that are achievable with present technology.

The values given in Table 4.1 are a summary of the tolerance values in IEC 60977 (2008c)

and are based on the methodology in IEC 60976 (2007). These values are broadly

consistent with the tolerances previously specified in IPEM 81 (1999), AAPM Report 46

(1994) and CAPCA standards (2005a). For a detailed description of test methods and

conditions, please refer to the IEC and IPEM documents. A list of suggested test equipment

is included in IEC 60977 (2008c). The table is intended to include the performance

parameters of all treatment devices incorporating a linear accelerator. All tests form part of

acceptance testing. Where tests are performed routinely for quality control, suggested

frequencies of testing are given in IEC 60977 (2008c), IPEM 81 (1999), AAPM Report 46

(1994), CAPCA standards (2005a) and other national QA protocols.

In the table, “IEC” refers to IEC 60976 (2007) and 60977 (2008c) and the numbers in the

Reference column refer to the clauses in these publications. “IPEM (1999)” refers to tables

in its section 5.2.


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Table 4.1 Summary of functional performance characteristics with tolerance/suspension

values for acceptance testing and quality control of a medical electron accelerator

Physical Parameter Tolerance/

Suspension

Level

Reference

(IEC (2007,

2008c) unless

stated)

Type

Uniformity of radiation fields 9

X-ray beams

Beam flatness in flattened area

(max/min ratio)

1.06

(see also IEC)

A

Beam symmetry (max/min ratio) 1.03 A

Dependence on gantry and collimator

angle

See IEC A

Beam flatness at dmax See IEC A

Wedge fields

Maximum deviation of wedge

factor

2 % IPEM (1999) B


factor with gantry angle

3 % IPEM (1999) B


angle

2° A

IMRT See IEC A

Electron beams

Beam flatness See IEC A

Dependence of flatness on gantry

and collimator angle

3 % A

Beam symmetry (max/min ratio) 1.05 A

Maximum surface dose (max/min

ratio)

1.09 See IEC A

Dose monitoring system 7

Calibration check 2 % A

Reproducibility 0.5 %

Proportionality 2 % IPEM (1999) 1% A, B

Dependence on angular position 2 % IPEM (1999) B

Dependence on gantry rotation 2 % A

Stability of calibration within day 2 % A

Stability in moving beam radiotherapy See IEC A

Depth dose characteristics See IEC 8 A

X-ray beams

Penetrative quality 2 % IPEM (1999) B

Depth dose and profile 2 % IPEM (1999) B

Electron beams A

Minimum depth of dmax 1 mm A

Practical range to 80% ratio 1.6 A

Penetrative quality 3 % or 2 mm A


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Maximum relative surface dose 100 % A

Stability of penetrative quality 1 % or 2 mm

Indication of radiation fields 10

X-ray beams A

Numerical field indication 3 mm or 1.5 %

See also IEC

A

For MLCs 3 mm or 1.5 %

See IEC

A

Light field indication 2 mm or 1 %

See also IEC

A

Centres of radiation field and

light field

2 mm or 1 %

See also IEC

A

For MLCs 2 mm or 1 %

See also IEC

A

For SRS/SRT 0.5 mm

See also IEC

A

Reproducibility 2 mm

SRS alignments 0.5 mm

See IEC

See also IPEM

(1999)

A, B

Electron beams

Light field indication 2 mm A

Collimator geometry

Parallelism of opposing edges 0.5° A

Orthogonality of adjacent edges 0.5° A

Beam centring with beam limiting

system rotation

2 mm A

Light field

Field size (10*10 cm2) 2 mm IPEM (1999) B

Illuminance (minimum) 25 lux A

Edge contrast ratio (minimum) 4.0 A

Indication of the radiation beam axis 11

On entry

X-rays 2 mm A

Electrons 4 mm A

SRS 0.5 mm A

On exit

X-rays 3 mm A

SRS 0.5 mm A

Isocentre 12

Radiation beam axis 2 mm IPEM (1999) 1

mm

A, B

Mechanical isocentre 1 mm IPEM (1999) B

Indication 2 mm

SRS 0.5 mm IPEM (1999) B

Distance indication 13

Isocentric equipment 2 mm IPEM (1999) A, B


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3mm

Non-isocentric equipment 5 mm A

Zero position of rotational scales 14

Gantry rotation 0.5° IPEM (1999) B

Roll and pitch of radiation head 0.1° A

Rotation of beam limiting system 0.5° IPEM (1999) B

Isocentric rotation of the patient support 0.5° A

Table top rotation, pitch and roll 0.5° A

Accuracy of rotation scales 1° IPEM (1999) B

Congruence of opposed radiation fields 1 mm 15

Movements of patient support 16

Vertical movements 2 mm A

Longitudinal and lateral movements 2 mm IPEM (1999) B

Isocentric rotation axis 1 mm A

Parallelism of rotational axes 0.5° A

Longitudinal rigidity 5 mm A

Lateral rigidity 0.5° and 5 mm A

Electronic imaging devices 17

Minimum detector frame time 0.5 s A

Corresponding maximum frame rate 2 / s A

Minimum signal-to-noise ratio 50 A

Maximum imager lag

Second to first frame 5 % A

Or fifth to first frame 0.3 % A

Minimum spatial resolution 0.6 lp/mm IPEM (1999) B

Detachable devices can be attached to either the treatment head or the couch. The former

include shadow trays and micro-MLCs, and the latter include devices such as stereotactic

frames, head shells, bite-blocks, etc. Where reproducible immobilisation and positioning of

the patient is required, the positional tolerance of these devices should be 2 mm in general

use and 0.5 mm for SRS.

3.7. SIMULATORS

IEC 60601-2-29 (2008b) is the standard which identifies those features of design that are




hazards. In a similar way to IEC 60976 (2007) and 60977 (2008c) for linear accelerators,

IEC 61168 (1993a) and IEC 61170 (1993b) specify test methods and functional


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performance values for radiotherapy simulators. The functional performance requirements

of radiotherapy simulators are directly related to the radiotherapy equipment being

simulated. The performance tolerances must therefore be at least equal to those

considered appropriate for the radiotherapy equipment and in many instances must be

better in order not to add to the total positioning errors. There are some differences from

recommendations published by national physicists‟ associations (IPEM (1999), AAPM

(1994) and CAPCA standards (2005b). Where recommendations from these bodies are

adopted they are indicated in the table

The values given in Table 4.2 are a summary of the tolerance values in IEC 61170 (1993b)

and are based on the methodology in IEC 61168 (1993a). Where additional tolerances (e.g.

for MLC and SRS/SRT simulation) have been suggested in the more recent linear

accelerator standards IEC 60976 (2007) and 60977 (2008c) and IPEM (1999), these are

indicated in the table. For a detailed description of test methods and conditions, please

refer to the IEC and IPEM documents.

All tests form part of acceptance testing. Where tests are performed routinely for quality

control, suggested frequencies of testing are given in IEC 61170 (1993b), IPEM (1999),

AAPM (1994), CAPCA (2005b) standards and other national QA protocols.

In the table, “IEC” refers to IEC 61168 (1993a) and 61170 (1993b).


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values for acceptance testing and quality control of a radiotherapy simulator


Suspension

Level

Reference

(IEC (1993a,b)

unless stated)

Type

Indication of radiation fields

Numerical field indication 2 mm or 1.0 %

See also IEC

IPEM (1999)

A, B

For MLCs 2 mm or 1.0 % IEC (2008c,

2007)

A

Light field indication 1 mm or 0.5 %

See also IEC

A

Centres of radiation field and light

field

1 mm or 0.5 %

See also IEC

IPEM (1999) A, B

For MLCs 1 mm or 0.5 % IEC (2008c,

2007)

A

For SRS/SRT 0.5 mm IEC (2008c,

2007)

A

Reproducibility 1 mm A

SRS alignments 0.5 mm IEC (2008c,

2007)

IPEM (1999)

A, B

Delineator geometry



Beam centring with beam limiting

system rotation

2 mm IEC (2008c,

2007)

A

Light field

Field size (10*10 cm2) 1 mm A

Minimum illuminance 50 lux A

Minimum edge contrast ratio 4.0 A

Indication of the radiation beam axis

On entry 1 mm IPEM (1999) B

SRS 0.5 mm IEC (2008c,

2007)

A

On exit 2 mm A

SRS 0.5 mm IEC (2008c,

2007)

A

Isocentre

Radiation beam axis 1 mm

See also IEC

IPEM (1999) A, B


Indication 1 mm IPEM (1999) B

SRS 0.5 mm IPEM (1999) B

Distance indication

From isocentre 1 mm A


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From radiation source 2 mm A

Image receptor to isocentre 2 mm A

Zero position of rotational scales


Roll and pitch of radiation head 0.1° IEC (2008c) A

Rotation of delineator 0.5° IPEM (1999) B

Isocentric rotation of the patient support 0.5° IEC (2008c) A

Table top rotation, pitch and roll 0.5° IEC(2008c) A


Congruence of opposed radiation fields 1 mm

Movements of patient support







Electronic imaging devices

Minimum detector frame time 0.5 s IEC (2008c,

2007)

A

Corresponding maximum frame rate 2 / s IEC (2008c,

2007)

A

Minimum signal-to-noise ratio 50 IEC (2008c,

2007)

A

Maximum imager lag

Second to first frame 5 % IEC (2008c,

2007)

A

Or fifth to first frame 0.3 % IEC (2008c,

2007)

A

Minimum spatial resolution 0.6 lp/mm IPEM (1999)

10.2.6

B

Radiographic QC

Alignment of broad and fine foci images 0.5 mm IPEM (1999) B

Fluoroscopic QC

Full radiographic and fluoroscopic tests IPEM (1999) B

Alignment of Shadow Trays 1 mm IPEM (1999) B

3.8. CT SIMULATORS

CT simulators usually comprise a wide bore CT scanner, together with an external patient

positioning and marking mechanism using projected laser lines to indicate the treatment

isocentre. This is often termed “virtual simulation”. Since this is an application of CT

scanning, there is no international standard. However quality assurance of the scanner and


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alignment system is essential to ensure that the isocentre is accurately located in the

treatment volume for subsequent treatment planning and treatment. The established

standards for CT scanners (see section 2.7) for good image quality and optimum patient

radiation dose apply. Acceptable quality assurance regimes are therefore based upon good

clinical practice. The most recent work is “Quality assurance for computed-tomography

simulators and the computed-tomography-simulation process”: (AAPM, 2003). The

tolerance limits in this report are designed to satisfy the accuracy requirements for

conformal radiotherapy and have been shown to be achievable in a routine clinical setting.

Further guidance is contained in IPEM Report 81 published in 1999. The guidance in Table

4.3 is based on these two reports. IPEM Report 81 suggests that the tests are done under

the same scanning conditions as those used clinically. Checks on image quality should

also be done after software upgrades in case they affect the calibration of the Hounsfield

Units. All tests form part of acceptance testing. Where tests are performed routinely for

quality control, suggested frequencies of testing are given in AAPM Report 83 (2003), IPEM

(1999), CAPCA (2007b) standards and other national QA protocols.


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values for acceptance testing and quality control of CT simulators

Physical Parameter Tolerance/ Suspension

Level

Reference (AAPM,2003) unless stated)

Type

Alignment of CT Gantry Lasers

With centre of the imaging plane ± 2 mm B

Parallel & orthogonal over length of laser projection

± 2 mm B

Alignment of Wall Lasers

Distance to scan plane ± 2 mm B

With imaging plane over length of laser projection

± 2 mm IPEM (1999) 1° B

Alignment of Ceiling Laser

Orthogonal with imaging plane ± 2 mm B

Orientation of Scanner Table Top

Orthogonal to imaging plane ± 2 mm B

Scales and Movements

Readout of longitudinal position of table top

± 1 mm IPEM (1999) 1 mm B

Table top indexing under scanner control ± 1 mm B

Readout of gantry tilt accuracy ± 1° B

Gantry tilt position accuracy ± 1° B

Scan Position

Scan position from pilot images ± 1 mm IPEM (1999) 1 mm B

Image Quality

Left & right registration None IPEM (1999) B

Image scaling 2 mm IPEM (1999) B

CT number/electron density verification ± 5 HU water B


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± 10 HU air ± 20 HU lung, bone

3.9. COBALT-60 UNITS

IEC 60601-2-11 (2004b) is the standard which identifies those features of design that are




hazards (i.e. controlling timer, selection and display of treatment related parameters,

leakage radiation and stray radiation). IEC 60601-2-11 (2004b) also includes requirements

for multi-source stereotactic radiotherapy equipment.

The IEC has not published performance tolerances for cobalt-60 units. The functional

performance characteristics and tolerance values in Table 4.4 are based on those for linear

accelerators in IEC 60976/7 (2008c, 2007) with some changes for cobalt-60 units. The table

does not address multi-source stereotactic radiotherapy equipment. There are some

differences from recommendations published by national physicists‟ associations (IPEM

(1999), AAPM (1994) and CAPCA (2006a) standards). Where recommendations from

these bodies are adopted, they are indicated in the table. For a detailed description of test

methods and conditions, please refer to the documents indicated.


control, suggested frequencies of testing are given in IPEM (1999), AAPM (1994), CAPCA

(2006a) standards and other national QA protocols.


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values for acceptance testing and quality control of cobalt-60 units


Suspension Level

Reference

(IEC (2008c)

unless stated)

Type

Uniformity of radiation fields

Beam flatness ± 3 % A

Beam symmetry ± 2 % IPEM (1999) B

Dependence on gantry and collimator

angle

See IEC 60976/7 A

Wedge fields


factor

2 % IPEM (1999) B


angle

2° A

Source position (when applicable) 3 mm AAPM (1994) B

Controlling Timer and Output

Checks

Timer check on dual timer difference 1 s IPEM (1999) B

Calibration check 2 % A

Reproducibility 0.5 % A

Proportionality 2 % A

Dependence on gantry rotation 1 % IPEM (1999) B

Stability in moving beam radiotherapy See IEC 60976/7 IEC 2007, 2008C,

Timer linearity 1 % AAPM (1994) B

Stability of timer ± 0.01 min A

Output vs field size 2 % IPEM (1999)

AAPM (1994)

B

Shutter correction 2 % IPEM (1999) B

Depth dose characteristics

Penetrative quality 1 % IPEM (1999) B

Depth dose and profile 2 % IPEM (1999) B

Indication of radiation fields

Numerical field indication 3 mm or 1.5 % IPEM (1999) 2 mm A, B

Light field indication 2 mm or 1 %

Centres of radiation field and light field 2 mm or 1 % AAPM (1994) 3

mm

A, B

Reproducibility 2 mm A

Collimator geometry



Beam centring with beam

limiting system rotation

2 mm A

Light field

Field size (10*10 cm2) 2 mm IPEM (1999) B


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Minimum illuminance 25 lux A

Minimum edge contrast ratio 4.0 A

Indication of the radiation beam axis

On entry 2 mm A

On exit 3 mm A

Isocentre

Radiation beam axis 2 mm IPEM (1999) 1 mm

AAPM (1994) 2

mm

A, B


Indication 2 mm A

Distance indication

Isocentric equipment 2 mm

IPEM (1999) 3 mm

AAPM (1994) 2

mm

A, B

Non-isocentric equipment 5 mm A

Zero position of rotational scales


Roll and pitch of radiation head 0.1° A

Rotation of beam limiting system 0.5° IPEM (1999) B

Isocentric rotation of the patient support 0.5° A

Table top rotation, pitch and roll 0.5° A


Congruence of opposed radiation

fields

1 mm A

Movements of patient support







3.10. KILOVOLTAGE UNITS

IEC 60601-2-8 (1997a) is the standard which identifies those features of design that are




hazards. Tests are based upon IPEM Report 81 (1999), which is based on a survey of UK

practice in 1991. Where recommendations from other bodies are adopted, they are


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indicated in the table. For a detailed description of test methods and conditions, please

refer to the IPEM (1999) and CAPCA (2005d) documents.


control, suggested frequencies of testing are given in IPEM (1999) and the CAPCA (2005d)

standard.


values for acceptance testing and quality control of kilovoltage units


Suspension

Level

Reference

(IPEM, 1999)

unless stated)

Type

Output calibration 3 % B

Monitor chamber linearity (if present) 2 % B

Timer end error 0.01 min B

Timer accuracy 2 % B

Coincidence of light and x-ray beams 5 mm CAPCA (2005d) 2

mm

B

Field Uniformity 5 % B

HVL constancy 10 % B

Measurement of HVL 10 % B

Applicator output factors 3 % B

3.11. BRACHYTHERAPY

IEC 60601-2-17 (2004c) is the standard which identifies those features of design that are




hazards (i.e. controlling timer, selection and display of treatment related parameters and

leakage radiation). This safety standard requires in the technical description the statement

of tolerances for radioactive source positioning, transit time and dwell time. It also limits the

value for the positioning accuracy to 2 mm relative to the specified position.

The values given in Table 4.6 are based on the tolerance values in ESTRO Booklet No. 8

(2004b), AAPM Report No. 46 (1996) and the CAPCA (2006b) standard.


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All tests form part of acceptance testing. For a detailed description of test methods and

conditions, please refer to the documents above. Where tests are performed routinely for

quality control, suggested frequencies of testing are given in the documents indicated in the

Table.


values for acceptance testing and quality control of brachytherapy equipment


Suspension

Level

Reference

(ESTRO, 2004B)

Type

Source calibration

Single source when only one source used

(e.g. HDR)

3 % AAPM (1994) B

Individual source in a batch

Mean of batch

(e.g. LDR or permanent implant)

5 %

3 %

B

Linear source uniformity of wire sources 5 % B

Source position 2 mm B

Applicator length 1 mm AAPM (1994) B

Controlling timer 1 % AAPM (1994) B

Transit time 1 % CAPCA (2006b) B

3.12. TREATMENT PLANNING SYSTEMS

IEC 62083 (2001b) “Requirements for the safety of radiotherapy treatment planning

systems” (RTPS) is the standard which identifies those features of design that are regarded

as essential for the safe operation of the equipment. It states that “the output of a RTPS is

used by appropriately qualified persons as important information in radiotherapy treatment

planning. Inaccuracies in the input data, the limitations of the algorithms, errors in the

treatment planning process, or improper use of output data, may represent a safety hazard

to patients should the resulting data be used for treatment purposes.” It is principally a

software application for medical purposes and is a device that is used to simulate the

application of radiation to a patient for a proposed radiotherapy treatment.

IAEA-TECDOC-1540 (2007b), addresses specification and acceptance testing of RTPSs,

using the IEC 62083 (2001a) document as a basis. This document gives advice on tests to

be performed by the manufacturer (type tests) and acceptance tests to be performed at the


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hospital (site tests). IAEA-TECDOC-1583 (2008a) addresses the commissioning of RTPSs.

Both are restricted to photon beam planning, but IMRT is not included. Criteria for the

acceptability of performance tolerances of IMRT plans, e.g. based on gamma calculations,

are an area of development and are not considered in this document. The IEC has not

published performance tolerances for RTPSs, and the tolerances for RTPS for photon

beams in table 4.7 are taken from IAEA-TECDOC-1583 (2008a), where descriptions of test

methods and conditions can also be found.


values for acceptance testing and quality control of external beam RTPSs


Suspension

Level

Reference

(IAEA,

2008a)

Type

Output factors at the reference point 2 % A

Homogeneous, simple geometry

Central Axis data of square and rectangular fields 2 % A

Off-axis data 3 % A

Complex geometry

Wedged fields, inhomogeneities, irregular fields,

asymmetric collimator setting;

Central and off-axis data

3 % A

Outside beam edges

In simple geometry 3 % A

In complex geometry 4 % A

Radiological field width 50% - 50% distance 2 mm A

Beam fringe / penumbra (50% - 90%) distance 2 mm A

QA for treatment planning systems is described in IAEA TRS-430 (2004a), AAPM (1998b),

ESTRO Booklet No 7 (2007a) for photon beams only and ESTRO Booklet No 8 (2007b) for

brachytherapy and the national protocols IPEM (1999) and CAPCA (2007a).

3.13. DOSIMETRY EQUIPMENT

The quality assurance of dosimetry equipment is considered by AAPM (1994), IPEM (1999)

and the CAPCA (2007c) standards. The CAPCA standard is largely based upon AAPM

(1994), but with some local measurements. IPEM (1999) has the most quantitative

measures. The tests from all reports are set out below in Table 4.8. For a detailed

description of test methods and conditions, please refer to these documents. Where tests


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are performed routinely for quality control, suggested frequencies of testing are given in

these documents.


values for acceptance testing and quality control of dosimetry equipment


Suspension Level

Reference

(IPEM, 1999)

Type

Ionisation Chambers

Leakage current 0.1 % AAPM (1994) B

Linearity 0.5 % AAPM (1994) B

Radionuclide stability check ≤ 1 %

Calibration against secondary standard 1 %

Beam Data Acquisition Systems

Positional accuracy 1mm CAPCA (2000c) B

Linearity 0.5 % AAPM (1994) B

Ion recombination losses 0.5 % B

Leakage current 0.1 % AAPM (1994) 0.5 % B

Effect of RF fields 0.1 % B

Stability of compensated signal 0.2 % B

Standard percentage depth dose plot 0.5 % B

Constancy of standard percentage depth

dose plot

0.5 % B

Standard profile plot: flatness 3 % B

Standard profile plot: field size 2 mm B

Accessories

Thermometer Calibration 0.5 deg C AAPM (1994) 0.1deg C B

Barometer calibration 1 mbar B

Linear rule calibration 0.3 % AAPM (1994) B

3.14. RADIOTHERAPY NETWORKS

Modern radiotherapy techniques rely on the transfer of large quantities of data and images

and require reliable data networks for safety and consistency. Quality control largely

relates to checking the correct functionality of processes and safety software, the accuracy

of new hardware and software and the comparison of data sets, sent, received or stored.

Testing most often occurs with the introduction of new developments. Regular testing can

be valuable to check for data corruption and hardware faults.

The guidance in this section is taken from IPEM Report 93 “Guidance for the

Commissioning and Quality Assurance of a Networked Radiotherapy Department” (2006)


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and the parameters needing to be checked routinely are listed in Table 4.9 below. See

IPEM Report 93 (2006) for a full description of the methods for checking these parameters.

Reference can also be made to ISO 17799:2005 “Information Technology – Security

Techniques – Code of Practice for Information Security Management” (2005) for general

advice on information security and national data protection legislation may also be

appropriate.

No suspension levels are given in table 4.9 because functionality must be correct for the

integrity of the data and its transfer. When a loss of functionality is detected, the use of the

network should be suspended until correct functionality is restored.

Table 4.9 Operating parameters to be checked routinely

Operating Parameter

Review of changes in assets, patch history, data stored, data disclosures, uses of data,

new or changed equipment and application software

Check of security fixes for Operating Systems and applications

Check that anti-virus software is up to date and enabled appropriately

Monitor logs for unexpected activity

Monitor availability of security updates and service packs on manufacturer‟ websites

Establish and monitor physical and network boundaries. Look for changes. Check

physical controls are in place and are effective

Communication channels

Dial out: Check that dial-in is not possible after changes in system configuration or system

upgrades. Check telephone numbers are dialled correctly. Check that assigned

telephone numbers have not been altered. Check log records for all attempted

connections, times, dates and endpoints

Auto answer (dial-in): Check lists of allowed dial-in sources, allowed times and any

changes in configuration settings, dial-back settings, etc. Check logs are as expected

All: Monitor link error rates. Check the accuracy of data transmission. Check traffic

encryption operating. Check for duplicate IP addresses. Monitor traffic for the presence of

new “unexpected” protocols, promiscuous mode on interfaces or unknown devices

appearing on the network

Check physical integrity of cables and terminations. Monitor and document changes in

physical network configuration. Monitor SNMP traffic logs for significant changes

DCHP: Monitor changes in the configuration files. Test DNS/DHCP allocation is

proceeding correctly. Look for new hosts in the lease allocation logs and new additions to

the network

Check routing tables are correct for static routes and that routed and gated daemons are

functional for dynamic routes. Check for propagation of routing information outside

network boundaries

Check that firewall rules have not been altered. Check that only allowed hosts, services or

packets are going through as new devices and applications are added to interior and

exterior networks. Check firewall log for intrusion signatures


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Establish which common services are necessary and provide a means of monitoring and

controlling access to them. Check that all essential services are operational

Perform security audits of physical location of clients, servers and other critical hardware.

Review access control measures and administrative personnel lists. Monitor logs for

console access and machine reboots, looking for discrepancies

Check logs for remote access and firewall logs for inappropriate clients or protocols

Examine system logs looking for sessions that are outside expected norms

Review and update the list of OSs, versions, service packs, applications and patch levels.

Test applied patches and updates as required in accordance with manufacturer‟s

instructions

Perform checks for new MAC addresses on the network (DHCP does this automatically).

Check that unused ports are disabled and/or unpatched. Check that used ports are set to

fixed MAC addresses where possible

Check the operation and configuration of the authentication system. Check the signatures

for the configuration files. Check password change dates are operating as planned.

Check that back door or manufacturer‟s passwords are not enabled or are changed

regularly

Monitor accounts added to the system for excessive permissions. Monitor system logs for

invalid administration log-in attempts

Transfer test data and checksum. Check for the addition of new fields and data types on

host systems. For DICOM transfers, use the DICOM ECHO verification service to check

connectivity and handshaking. For HL7 transfers, check connectivity

Check backup logs for errors and omissions, and error rates to verify the media is good

and hardware is not failing. Backup policy must include a retirement age for media.

Destroy data no longer required. Practice disaster recovery regularly

Review data flows looking for new cached items. Run reports checking the coherency of

the data across the system

Check for the effect of software upgrades, new equipment added, changes in configuration

and data files. Check the signatures of significant files and update if necessary. Verify

that the change control process is working

Perform checks that permissions and shares have not changed from those expected

Monitor available space, CPU utilisation and use of swap memory on critical devices

Check NTP client logs for synchronisation failures. Check reference time sources for

offset and stability. Check that server and client time zone settings have not been

modified. Check system time against an independent time source

Check that record locking on files and databases have not been broken after any OS

changes including service packs, client set-up changes and upgrades

Data

Unique identification

Geometric integrity and scaling

Region of acceptability of data accuracy and integrity

Coordinate frame orientation and location

Patient orientation and specification within the coordinate frame

Tolerances on images with respect to

pixel values

geometric distortion


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APPENDIX 1 INFORMATIVE NOTE ON IMAGING PERFORMANCE

The general purpose of medical imaging is to obtain adequate image quality at the lowest possible

radiation burden to the patient. Assessment of image quality is, therefore, important. Various

methods are available for quantification of image quality (Table DR1.1 based on ICRU Report 54,

1995).

Table A1.1 Assessment of (image) quality at various physical/medical levels

Approach Methods used

Physical (fundamental) image quality

Large-scale transfer function (characteristic curve),

spatial resolution (transfer function), noise (noise

power spectra)

Statistical decision theory Ideal observer formalism, other observers

Psychophysical approach (ROC) analysis, contrast detail method

Quality assessment using phantoms for a

specific imaging task

Specific test objects, e.g. for high and low contrast

spatial resolution

Examination of images of patients European image quality criteria (diagnostic

radiographic and CT images)

The methods range from those requiring high levels of expertise and facilities (transfer functions),

are very elaborate (ROC analysis) to methods which are in principle applicable in the field in a

department of radiology.


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APPENDIX 2 AUTOMATIC EXPOSURE CONTROL

Methodology, CR and DDR

CR, DDR and AEC

The following Tables provide additional information in connection with CR and DDR AEC.

They are complementary to the data in Section 2.2 of the text.

Table A2.1 Acceptability criteria for the AEC device (CR)

Physical parameter Suspension Level Reference Criterion Notes

Consistency between

chambers

Mean ± 20% IPEM

(2005a)

B Attenuation

material

Repeatability Mean ± 30% IPEM

(2005a)

B Attenuation

material

Consistency Mean ± 60% IPEM

(2005a)

B Attenuation

material

Image receptor dose

Speed Class 400:

> 2.5 µGy± 60%

Speed Class

200:

> 5 µGy± 60%

IPEM

(2005a)

B Dosemeter.

1mm-2mm

copper filter

Table A2.2 Acceptability criteria for AEC device (DDR)

Physical parameter Suspension

Level

Reference Criterion Method

Consistency between

chambers

IPEM (2005a) B Attenuation

material

Repeatability Mean ± 30% IPEM (2005a) B Attenuation

material

Consistency Mean ± 60% IPEM (2005a) B Attenuation

material

Image receptor dose

Manufacturers

Specification ±

60%

IPEM (2005a) B Dosemeter,

1.0mm copper.


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APPENDIX 3 EQUIPMENT

Quality Control Equipment for Radiology Calibration

Instruments should have calibration traceability. Dosimetric instrumentation should comply

with IEC (1997b) and follow international guidelines (IAEA, 2004b). Care should be taken

for measurements in the beam conditions outside of those defined by IEC (1997b) (e.g.

some situations in mammography, computed tomography and interventional radiology and

all situations involving scatter radiation). In these conditions the use of instruments with a

small energy response variation is strongly encouraged. Field (or clinical) KAP meter

calibration should be performed in situ using a calibrated reference instruments using one

of two methods as described in IAEA (2007a) and Toroi, Komppa and Kosunen (2008).

Some useful equipment

Radiographic instrumentation

Calibrated non invasive tube kVp meter (IAEA, 2007a)

Dosimeter calibrated in terms of air kerma free-in-air with specialized detectors for

measurements in different modalities (ICRU, 2005; IAEA, 2007a).

Indication of current exposure time product (on the x-ray unit or by ancillary

equipment).

Instrument calibrated for measurement of exposure time.

Auxiliary equipment

Accurate tape measure and steel rule

Aluminium filters (type 1100, purity > 99%) ranging from 0.25 mm to 2 mm (HDWA,

2000).

Lead rubber sheet(s).

Attenuator set and supports

Radio-opaque grid or equivalent

Collimation and Alignment tools: X-ray field mapping device, e.g. radiographic film,

Gafchromic film or equivalent.

Radio-opaque markers – coins or paper clips.

Small lead or copper block

Film Screen Contact Test Tool (Mesh Test Tool).

Non-mercury thermometer, with a range of 25-40 oC and an accuracy of ± 0.1oC.

Geometry test object

High contrast resolution tool (Hüttner 18)


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Phantoms

Standard CT dose phantoms, Body 32-cm PMMA, Head 16 cm PMMA

CT uniformity (water) phantoms

Slice thickness phantom; Inclined planes – axial acquisition, Thin disc or bead

Measurements to assess the performance of DXA units may have to be performed

using test equipment, some of which is specifically designed for that purpose

PMMA phantoms of 10, 12, 15, 18 and 20 cm thickness.

Standard phantom, e.g.: European Spine Phantom [7, 12], BFP [8]

Tomography

Test tool (BIR, 2001; IPEM, 1997b).

Test tool for angle of swing, i.e. a 45º foam pad, pin-hole or other appropriate test

tool (IPEM, 1997b)

Instrumentation for light and image display

Calibrated Photometer for measuring luminance and illuminance.

Test pattern Image such as SMPTE or T018-QC

Calibrated Sensitometer with 21 steps or pre-exposed sensitometry strips.

Calibrated Densitometer, accuracy of ± 0.01 OD.


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REFERENCES & SELECTED BIBLIOGRAPHY

AAPM (1992) American Association of Physicists in Medicine. Recommendations on performance characteristics of diagnostic exposure meters. AAPM Report No 35. (Also published in Med. Phys. 19 (1) 231-241. [Medline]

AAPM (1994) American Association of Physicists in Medicine. Comprehensive QA for Radiation Oncology. Report No 46. Med. Phys. 21 (4), 581-618.

AAPM (1995) American Association of Physicists in Medicine. Quantitation of SPECT Performance. Report No 52. Med. Phys. 22 (4) April.

AAPM (1997) American Association of Physicists in Medicine. Code of practice for brachytherapy physics. Report No 59. Med. Phys. 24 (10), 1557-1598.

AAPM (1998a) American Association of Physicists in Medicine. High dose-rate brachytherapy treatment delivery. Report No 61. Med. Phys. 25 (4), 375-403.

AAPM (1998b) American Association of Physicists in Medicine. Quality assurance for clinical radiotherapy treatment planning. Report No 62. Med. Phys. 25 (10), 1773-1829.

AAPM (2002) American Association of Physicists in Medicine. Quality control in diagnostic radiology. Report No 74. July. New York: American Institute of Physics.

AAPM (2003) American Association of Physicists in Medicine. Quality assurance of computed-tomography simulators and the computed-tomography-simulation process. Report No 83. Med. Phys. 30 (10), 2762-2792.

AAPM (2005) American Association of Physicists in Medicine. Assessment of display performance for medical imaging systems. Report OR-03. [Online] Available at http://www.aapm.org/pubs/reports/OR_03.pdf (Accessed: 30 September 2009)

AAPM (2006a) American Association of Physicists in Medicine. Acceptance testing and quality control of Photo Stimulable Phosphor Imaging Systems. Report No 93. New York: American Institute of Physics.

AAPM (2006b) American Association of Physicists in Medicine. Validating Film Processor Performance. Report No 94. November. College Park, MD: American Association of Physicists in Medicine.

Adrian Committee (1960). Radiological Hazards to Patients. Second Report to the Committee. London: Her Majesty‟s Stationery Office.

AFSSAPS (2007) Agence Française de Sécurité Sanitaire des Produits de Santé. „Protocole AFSSAPS CT‟, Journal Officiel de la République Française.

ARPANSA (2005) Australian Radiation Protection and Nuclear Safety Agency. Code of Practice & Safety Guide. Radiation Protection Series No. 10, December. Australia: Radiation Protection in dentistry.

Besluit van het FANC (2008, December 12) Belgian directive: Aanvaardbaarheidscriteria voor röntgenapparatuur voor diagnostisch gebruik in de tandheelkunde.


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BIR (2001) British Institute of Radiology. Assurance of Quality in the Diagnostic X-ray Department. 2nd edn. London: British Institute of Radiology.

BSI (1994) British Standards Institute. BS EN ISO 9002: Quality Systems – Specification for Production, Installation and Servicing. London: British Standards Institute.

Bland, W. F. (1994) „CEC suggested technical criteria for radiodiagnostic equipment‟. September.

CAPCA (2005a) Canadian Association of Provincial Cancer Agencies. Standards for Quality Control at Canadian Radiation Treatment Centres, Medical Linear Accelerators. Canada.

CAPCA (2005b) Canadian Association of Provincial Cancer Agencies. Standards for Quality Control at Canadian Radiation Treatment Centres, Conventional Radiotherapy Simulators. Canada.

CAPCA (2005c) Canadian Association of Provincial Cancer Agencies. Standards for Quality Control at Canadian Radiation Treatment Centres, Electronic Portal Imaging Devices. Canada.

CAPCA (2005d) Canadian Association of Provincial Cancer Agencies. Standards for Quality Control at Canadian Radiation Treatment Centres, Kilovoltage X-ray Radiotherapy Machines. Canada.

CAPCA (2006a) Canadian Association of Provincial Cancer Agencies. Standards for Quality Control at Canadian Radiation Treatment Centres, Cobalt-60 Teletherapy Units. Canada.

CAPCA (2006b) Canadian Association of Provincial Cancer Agencies. Standards for Quality Control at Canadian Radiation Treatment Centres, Brachytherapy Remote Afterloaders. Canada.

CAPCA (2007a) Canadian Association of Provincial Cancer Agencies. Standards for Quality Control at Canadian Radiation Treatment Centres, Treatment Planning Systems. Canada.

CAPCA (2007b) Canadian Association of Provincial Cancer Agencies. Standards for Quality Control at Canadian Radiation Treatment Centres, CT-Simulators. Canada.

CAPCA (2007c) Canadian Association of Provincial Cancer Agencies. Standards for Quality Control at Canadian Radiation Treatment Centres, Major Dosimetry Equipment. Canada.

CEC (2006) Commission of the European Communities. European guidelines for quality assurance in mammography screening. 4th Edn. Luxembourg: European Commission.

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http://dx.doi.org/10.1088/0031-9155/53/18/006


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ACKNOWLEDGEMENTS

Coordinator: Dr Keith Faulkner

Diagnostic Radiology Lead: Prof Jim Malone

Nuclear Medicine Lead: Dr Stelios Christofides

Radiotherapy Lead: Prof Stephen Lillicrap

Contributors

Diagnostic Radiology

Dr Steve Balter

Dr Norbert Bischof

Dr Hilde Bosmans

Ms Anita Dowling

Aoife Gallagher

Remy Klausz

Dr Lesley Malone

Ian (Donald) Mclean

Dr Alexandra Schreiner

Dr Eliseo Vano

Colin Walsh

Dr Hans Zoetelief

Nuclear Medicine

Dr Inger-Lena Lamm

Dr Soren Mattsson

Radiotherapy

Prof Patrick Horton

Dr Inger-Lena Lamm

Dr Wolfgang Lehmann

Reviewers

Dr Tamas Porubszky

Mr S. Szekeres

Markku Tapiovaara

Kalle Kepler

Koos Geleijns

Simon Thomas PhD FIPEM

Geraldine O‟Reilly

criteria for acceptability of radiological, nuclear...

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