21 cfr subchapter j to iec comparison table for …...mita wp x – 201x page 1 a nema medical...

MITA WP X – 201X

A NEMA Medical Imaging & Technology Alliance Document

MITA WP X – 201X

21 CFR Subchapter J to IEC Comparison Table for Medical X-Ray Imaging Devices

General Radiography and Fluoroscopy, and Interventional Fluoroscopy

Prepared by

NEMA X-Ray Section National Electrical Manufacturers Association 1300 North 17th Street, Suite 900 Rosslyn, Virginia 22209

The requirements or guidelines presented in this document, a NEMA Medical Imaging & Technology

Alliance white paper, are considered technically sound at the time they are approved for publication. They

are not a substitute for a product seller’s or user’s own judgment with respect to the particular product

discussed, and NEMA does not undertake to guarantee the performance of any individual manufacturer’s

products by virtue of this document or guide. Thus, NEMA expressly disclaims any responsibility for

damages arising from the use, application, or reliance by others on the information contained in these

white papers, standards, or guidelines.

The assessment performed in this white paper was completed using the standards referenced which may

or may not be the most recent versions of 21 CFR Subchapter J or IEC standards. It is the user’s

MITA WP X – 201X

responsibility to ensure the applicable standards are being considered and that all applicable regulations

and regulatory guidance are being followed.

This whitepaper is part of an ongoing initiative in collaboration with FDA and professional societies and

represents our current understanding of how to comply with the FDA draft guidance “Medical X-Ray

Imaging Devices Conformance with IEC Standards.” It does not take into account the FDA’s final

guidance to manufacturers, which has not yet been published at this time, and is subject to change. At

this time, the whitepaper is only viewable, but will be available freely once finalized.

MITA WP X – 201X

Table of Contents

Table of Contents

1 Background ....................................................................................................................................... 4

2 Proposed Solution ............................................................................................................................. 4

3 Table Template ................................................................................................................................. 5

4 Appendix A – 21 CFR Requirements that would not be deemed to be met based solely on

conformity to IEC standards ................................................................................................................... 19

5 Appendix B – Requirements Related to Obsolete Equipment or Standards .................................. 21

6 Appendix C – Items Included on X-Ray Inspector Tests of Diagnostic Equipment ......................... 22

MITA WP X – 201X

1 Background

FDA published a draft guidance in 2016 entitled ‘Medical X‐Ray Imaging Devices Conformance with IEC Standards’ introducing FDA’s interest in allowing device manufacturers subject to 21 CFR Subchapter J performance standards (hereafter abbreviated as 21 CFR) to voluntarily demonstrate conformance to relevant IEC standards where such standards exist. MITA supports this proposal and the movement towards international consensus standards. We strongly believe that reliance on up-to-date, consensus-based, internationally recognized safety standards furthers the shared duty to protect public health and will provide improved protection from electronic radiation. To achieve this goal, resources are needed to ensure that other stakeholders who rely on 21 CFR can adequately perform their role in radiation protection. For example, medical physicists, state, and local radiation programs currently test to FDA performance standards (21 CFR), either explicitly through legislation or in well-established practice, and may have little experience/familiarity with IEC standards and related testing. To support these professionals and their use of IEC standards, this document provides a framework for manufacturers to communicate pertinent system requirements and test methods to interested parties to facilitate this transition.

2 Proposed Solution

After discussions with multiple stakeholders, the following general framework was proposed: manufacturers, should they wish to conform to IEC standards instead of 21 CFR performance standards, will create a table that highlights, for each modality, product family, and/or model, where either their product is designed to meet an IEC requirement that conflicts with the 21 CFR performance standard or where unique conformance testing procedures are required to determine compliance with IEC requirements.

The table would provide the relevant IEC requirement or testing procedure, so that state inspectors and medical physicists could test independently to confirm that the product conforms to the IEC standard.

This table would need to be publicly available to allow stakeholders to test to either IEC or 21 CFR or both and would obviate the need for physical ownership of IEC standards.

Manufacturers are responsible for adopting the framework described in this white paper and providing product specific requirements and test methods.

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Note: Transitioning to IEC ‐ and publishing a table specifying where 21 CFR and IEC requirements differ ‐ is voluntary; Manufacturers may elect to continue to comply with 21 CFR requirements and tests. MITA supports this comparison table as a reasonable least-burdensome approach to communicate IEC specifications and test methods that are different from 21 CFR requirements, allowing medical physicists and state inspectors to understand the requirements and update their testing procedures accordingly. Through the process of creating and vetting this table, MITA confirms IEC standards referenced contain similar and in many cases more prescriptive descriptions of specifications/tests than current 21 CFR standards. MITA also commits to making these comparison tables publicly available via a central Web based “landing page”, hosted by MITA, which directs users to the manufacturer’s site dedicated to providing the information. The manufacturers retain autonomy on how the information is provided.

All IEC clauses referenced in the following table are reproduced in the accompanying 21 CFR Subchapter J to IEC Reference to allow users to understand the exact text. 21 CFR Subchapter J performance standards are publicly available on FDA’s website.

3 Table Template

This table is for a representative, radiographic and fluoroscopic x‐ray system intended for adult and pediatric use. This representative system conforms only to

the minimum (“shall”) requirements of 60601‐2‐54:2009 and 60601-2-43:2010 and does not necessarily conform to the requirements of FDA’s performance standards unless those requirements are also part of the IEC standard. This table highlights where the product fails to meet a 21 CFR requirement but meets a corresponding, less stringent IEC requirement or where unique testing procedures are required to determine compliance with IEC requirements. The FDA guidance noted in the introduction also includes a table of 21 CFR requirements that would not be deemed to be met based solely on conformity to IEC standards; therefore, these requirements are not included in the table below, but are instead provided in Appendix A for reference. Several requirements were identified which are only applicable to obsolete technology. These requirements will not be considered for product specific tables but are provided in Appendix B for reference. The comparisons are split between two tables. Table 1 provides requirements/test methods for common field tests. Table 2 provides requirements/test methods that are primarily checked by manufacturers and

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certified labs as part of the device design verification. A list of common field tests was provided by CRCPD and provided in Appendix C for reference. When manufacturers adopt this template for a particular product, they should only consider applicable requirements based on system type. Radiographic-only systems should comply with IEC clauses related to 1020.30 and 1020.31. Fluoroscopy-only systems should comply with IEC clauses related to 1020.30 and 1020.32. Systems capable of doing radiography and fluoroscopy should comply with IEC clauses related to 1020.30, 1020.31, and 1020.32. If Assembly, Installation, Adjustment, and Testing (AIAT) documentation is provided electronically on the device, then the comparison table will be included as part of that electronic documentation. Any digital version of the comparison table should be provided in a searchable format. <Remove this section to this point for product specific table>

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21 CFR Subchapter J to IEC Comparison Table for <insert device name(s) here>

Following the guidelines set forth in MITA WP X – 201X and FDA 2016 draft guidance ‘Medical X‐Ray Imaging Devices Conformance with IEC Standards,’ the following tables outline where these device(s) either fails to meet an applicable 21 CFR Subchapter J standard but meets the corresponding IEC requirement or instances where the IEC standard specifies testing methodology that could affect the results of testing. This comparison table assesses 21 CFR Sub J against the following IEC standards:

IEC 60601-1-3 Ed. 2.0: 2008

IEC 60601-2-28 Ed. 2.0: 2010

IEC 60601-2-43 Ed. 2.0: 2010

IEC 60601-2-54 Ed. 1.0: 2009 <Manufacturers should state the IEC standards appropriate to the device. Newly developed devices should consider the latest recognized standards and transition periods in their design. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/results.cfm

Table 1 – 21CFR to IEC Comparison Table - Common Field Tests. This table outlines applicable standards and testing methodology for requirements that are commonly tested during state inspections. Commonly tested requirements were provided by CRCPD and included in MITA WP X – 201X Appendix C.

21 CFR

Subchapter

J Reference

IEC Reference

Topic IEC/EPRC Comparison

Specifications/testing information specific to this device

1020.30(c) None Certification label CFR includes certification label language, while IEC

This device includes the following certification label: Complies with 21 CFR Subchapter J and, in lieu of [insert FDA performance standard CFR number(s)], with IEC

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does not require certification. The FDA guidance "Medical X-Ray Imaging Devices Conformance with IEC Standards" explains how manufacturers should certify their components when declaring conformance to IEC standards rather than FDA’s performance standards.

[insert IEC Standard number and edition number], dated [Insert publication date of the FDA-recognized IEC standard], [add, as appropriate] including corrigenda dated [insert publication dates of the FDA-recognized corrigenda] and amendments dated [insert publication dates of the FDA-recognized amendments], as permitted by "Medical X-Ray Imaging Devices: Conformance with IEC Standards;” dated [Insert date of final guidance issuance].”

1020.30(k) 60601‐1‐3: 12.4

60601‐2‐54: 203.12.4

Leakage radiation CFR requires less than 0.88 mGy per hour, while IEC requires less than 1.0 mGy per hour.

This system limits leakage radiation from the diagnostic source assembly to no more than 1 mGy/hr. Testing of leakage radiation from the diagnostic source

assembly should be performed with the following testing

conditions and acceptance criteria:

Reduce collimator to smallest available field size and

block remaining field sufficiently (to ensure that

measurement is not affected by radiation passing

through). Set the fluoroscopic tube voltage to the

nominal value and the tube current to a convenient

value. Remove any patient support devices, optional

accessories, or nearby equipment which might interfere

with scatter radiation measured at 1m from the focal

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spot. Take air kerma/air kerma rate measurements for

10 seconds at each of the location(s) depicted below.

<insert diagram of system with the known location(s) of

highest leakage radiation accounting for tube housing

assembly shielding, anode shielding, cosmetic cover

shielding, etc.> Normalize the highest leakage radiation

measurement to the value of air kerma in one hour by

multiplying the result by <multiplier commensurate with

highest continuous use or 1 hour> <this is required to be

provided according to 60601‐1‐3 clause 12.3>.

Acceptance criteria is <must be less than 1.0 mGy in one

hour>

1020.31(a)(1) 60601-2-54: 203.6.4.3.102

Indication of Technique Factors

CFR states that all technique factors must be visible from the operators' position. However, if a system limits the technique factors selections by the operator to one or more fixed combinations, IEC requires only one of those technique factors (like kV) to be displayed on the control panel. This is

Because this system limits technique factor selections to certain combinations, the system only displays one technique factor. The fixed combinations of technique factors are provided in the instructions for use.

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allowed if the fixed combination of technique factors is provided in the instructions for use.

1020.31(a)(4) 60601‐2‐54: 203.6.4.3.104.3,

203.6.4.3.104.4,

203.6.4.3.104.5, 203.6.4.3.104.6

Measurement of technique factor accuracy - Radiography

CFR does not specify measurement criteria for technique factors, while IEC specifies measurement conditions that could affect the results.

The following technique factors should be evaluated as stated below and accuracy compared to the values provided in the information to users:

Peak Tube Potential: 3 measurements

Lowest tube potential, highest available tube current, and shortest available exposure time

Lowest tube potential, highest available tube current, and exposure time ~0.1s

Highest tube potential, highest available tube current, and exposure time ~0.1s

Tube Current: 3 measurements

Lowest tube current, highest available tube potential, and shortest available exposure time

Lowest tube current, highest available tube potential, and exposure time ~0.1s

Highest tube current, highest available tube potential, and exposure time ~0.1s

Scan Time: 2 measurements

Lowest indicated exposure time, highest available tube potential, and any available tube current.

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Lowest indicated exposure time, highest available electric power.

Tube Current and Exposure Time Product (mAs): 2 measurements

Lowest indicated mAs, highest available tube potential

Highest indicated mAs, highest available tube potential

1020.31(e)(1) 60601-2-54: 203.8.104(a)

Center-to-center CFR requires 2% of SID, whereas IEC does not specify any tolerance.

This system does not specify a tolerance for center-to-center measurement.

1020.31(e)(1) 60601-1-3: 8.5.2 SID Indication CFR requires 2% accuracy, while IEC requires 5% SID indication accuracy.

This system has an SID indication accuracy of 5%.

1020.31(e)(2) 60601-2-54: 203.8.102.2

Limitation of X-Ray Field to Image Receptor

CFR requires that the beam-limiting device numerically indicate the field size in the plane of the image receptor, while IEC allows exemptions for field size indication.

Display of the field size is not provided in the following circumstances (exemptions):

a) Field size is preset for distances of interest and are not selectable by the operator

b) System contains an interlock that does not allow an exposure if the x-ray field exceeds the image receptor

c) During fluoroscopy, the boundaries of the x-ray field can be displayed visually.

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1020.31(e)(3) 60601-2-54: 203.8.102.2


CFR requires numeric indication of field size dimensions in centimeters and/or inches, while IEC allows the use of graphical symbols instead of numeric marking.

This device indicates field size dimensions using graphical symbols.

1020.31(i)(2) 60601‐2‐54: 203.9.102

Minimum Source to Skin Distance

CFR limits SSD to 30 cm for mobile and portable systems, while IEC limits SSD to less than 20 cm for radiography.

This system permits radiography with a minimum source‐skin distance of 20 cm.

1020.32(a) 60601-2-54: 203.11.101

Primary Protective Barrier Limit

CFR uses a percentage of entrance AKR; IEC uses a specific use case (mA and leakage radiation). CFR and IEC specify different requirements for the attenuation block.

Testing of the Primary Protective Barrier should be performed with the following testing conditions and acceptance criteria:

Place shielding in the image receptor plane which is

outside of the image receptor. Select smallest available

filtration and remove anti‐scatter grid. Insert a phantom

with attenuation equivalent of 40 mm Al at the exit port

of the collimator. Set the smallest SID and largest field

size available. Tube voltage set at nominal tube voltage

for fluoroscopy. Tube current set as 3 mA.

Acceptance criteria is <must be less than 150 µGy in one hour>

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1020.32(b)(4)(ii) 60601-2-54: 203.8.5.3

Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors

The CFR dictates a different measurement criterion depending on the size of the visible area, where the IEC is absolute for all image receptors. The IEC also exempts those less than 10 cm, where the CFR does not.

This system contains a circular image receptor that is greater than 10cm in diameter, so IEC controls the field limitation of the circular image receptor (minimum of 80% of overlap between image receptor and x-ray field, no extent of the x-ray field beyond 2 cm from the image reception area)

1020.32(d)(2)(i) 60601-2-54: 203.6.3.101

Automatic Exposure Controls

The CFR allows equipment without AERC (Automatic Exposure Rate Control) if the maximum air kerma rate does not exceed 44 mGy/min whereas the IEC specifies that the maximum air kerma rate be restricted to the limit stated in local regulations. 21 CFR is the applicable local regulation for the US and 1020.32(d)(2)(i)

For equipment without AERC, the maximum air kerma rate in fluoroscopy is limited to 44mGy/min unless optional high-level controls are implemented.

(21 CFR requirement is followed as the applicable local regulation)

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applies.

1020.32(d)(2)(i) 60601-2-54: 203.6.5

Automatic Exposure Controls

The CFR mandates all systems that can shoot above 44 mGy per minute have AEC. The IEC requires AEC, but allows exemptions per Risk management (e.g. for mobile systems) to take technical limitations into account.

This system includes manual exposure controls for modes up to 55 mGy per minute, per the manufacturer’s risk file.

1020.32(f)

60601‐2‐54: 203.6.4.3.104.3,

203.6.4.3.104.4,

203.6.4.3.104.5

Measurement of technique factor accuracy - Fluoroscopy

CFR does not specify measurement criteria for technique factors, while IEC specifies measurement conditions.

The following technique factors should be evaluated as stated below and accuracy compared to the values provided by the manufacturer:

Peak Tube Potential: measurements taken at 60% and 90% of maximum available x‐ray tube voltage

Tube Current: measurements taken at 20% of maximum available tube current

with one measurement at lowest available peak tube potential and one

measurement at highest available peak tube potential

Scan Time: measurements taken at the lowest available exposure time with one measurement at the highest available electric power and one measurement at the highest peak tube potential available and any available

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tube current.

1020.32(h)(2) 60601-2-54: 203.6.4.5 60601-2-43: 203.6.4.5

Fluoroscopic irradiation time

CFR requires a display of the fluoroscopic irradiation time at the fluoroscopist's working position. The IEC 60601-2-54 recommends it (should) to be made available. The IEC 60601-2-43 requires it.

This device counts the fluoroscopic irradiation time during an overall examination in cumulating the times when the x-ray tube is activated.

1020.32(h)(2)(i) 60601‐2‐54:

203.6.4.3.101

Fluoroscopic irradiation

time display

CFR requires minutes and tenths of minutes, while IEC allows for minutes and seconds as well as minutes and tenths of minutes

This device displays fluoroscopic irradiation time in minutes and seconds in lieu of minutes and tenths of minutes.

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1020.32(h)(2)(ii) 60601‐1‐3: 6.2.1

60601‐2‐54: 203.6.2.1

Radiation time alarm

CFR requires an alarm after 5 minutes of fluoroscopy. In IEC, the maximum radiation time is 5 minutes, though the system can be configured to alarm at a shorter interval.

This device may be configured with a fluoroscopic irradiation timer which is actuated after less than 5 minutes.

Multiple 60601‐2‐54:

203.6.3.2.103.1

Air Kerma measurement

method

CFR does not specify conditions for the air kerma measurement, while IEC specifies measurement conditions that could affect the results.

Measurements of Air Kerma should be made with the x‐ray field reduced to a size as small as possible to minimize scattered radiation.

Table 2 – 21CFR to IEC Comparison Table – All Other Requirements. This table outlines applicable standards and testing methodology for requirements that are not commonly tested during state inspections. These requirements/test methods are primarily checked by manufacturers and certified labs as part of the device design.

21 CFR

Subchapter

J Reference

IEC Reference

Topic IEC/EPRC

Comparison


MITA WP X – 201X

1020.30(h)(2)(ii) None User Documentation-Tube Cooling Curves

CFR specifies a requirement to include tube cooling curves in user documentation, but IEC has no such requirement.

The user documentation for this device does not include tube cooling curves.

1020.30(h)(2)(i), 1020.30(h)(4)(ii)

60601‐1‐3: 7.3 and 7.6

User documentation- Description of filtration

in the useful beam

CFR specifically states aluminum equivalence, while IEC allows manufacture to specify the chemical composition and thickness of the filter.

For this system, the minimum filtration permanently in the useful beam and added filtration are expressed (indicated) by thickness and chemical composition in lieu of equivalent mm/AL. Note: Limits and measurement of minimum permissible first Half-Value Layer (HVL) are still given in mm/AL with same limits as CFR.

1020.30(m)(2) 60601-2-54: 203.7.1

Optional Filtration CFR requires additional filtration for devices above a certain power rating, while IEC only requires additional filtration for systems with pediatric indications.

Even though this device has a continuous output of 1 kW and an anode heat storage capacity of more than 1 million heat units, no additional filtration is provided because the device is indicated for adult use only.

1020.31(d)(1), 1020.32(b)(2)

60601‐2‐54: 203.8.102.1


CFR requires stepless adjustment for visible areas greater than 300 square cm, but

This system provides stepped adjustment of the x‐ray field in increments of 1cm or less.

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IEC allows stepped adjustment (steps not exceeding 1 cm) for all image field sizes.

1020.31(d)(2)(ii) 60601‐2‐54: 203.8.102.5

Light localizer CFR requiers min. 160 lux @ 1m SID, IEC requiers min. 100 lux @ 1m SID.

CFR allows measurement in 1m or max. SID, IEC only at 1m distance

1020.31(l)(1) None Radiation from Capacitive Discharge Generators

CFR limits radiation from capacitive discharge systems when charged, but not enabled, to 0.26 microGy @ 5 cm

This device does not employ capacitive discharge generator technology.

1020.31(l)(2) None Radiation from Capacitive Discharge Generators

CFR limits radiation from capacitive discharge systems when discharged (not activated), to 0.88 mGy @ 100 cm.

This device does not employ capacitive discharge generator technology.

1020.32(b) 60601‐2‐54: 203.8.101

Determining the

boundary of the x‐ray field

CFR defines x-ray field as 25% of the highest AKR of the quadrants’ centers, while IEC has an alternative definition.

This system's x‐ray field is defined as the perimeter of points at which the air kerma rate is 25% of the mean of the air kerma rates at the approximate centers of the quarters of the area enclosed, rather than 25% of the highest AKR of the quadrants’ centers.

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1020.32(b)(1) 60601-2-54: 203.8.104(d)

Positioning of the X-RAY BEAM AXIS

The CFR states that a means must be provided to indicate when the beam is perpendicular whereas IEC allows this to be in the operator manual.

This system includes explanation of when the beam is perpendicular in the user manual in lieu of indication on the system.

4 Appendix A – 21 CFR Requirements that would not be deemed to be met based solely on conformity to IEC

standards This table describes 21 CFR product requirements that manufacturers must continue to meet even if following the

IEC conformance method.

<Provided as a reference. Do not include this appendix in product specific table.> 21 CFR

Subchapter

J Reference

Topic

1002 Subparts A, C, D, E, F

Records and Reports

1010.3 Identification

1010.4 Variances (from EPRC requirements only)

1020.30(a) Applicability

1020.30(b) Definitions

1020.30(d) Assemblers Responsibility

1020.30(e) Identification of x-ray components

1020.30(g) Information Provided to Assemblers

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1020.30(j) Warning Label

1020.30(q) Modification of Certified Components

1020.32(d)(3)(v) Lateral Plane patient entrance point

1020.32(g) Source-skin distance

1020.33(d) Quality assurance

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5 Appendix B – Requirements Related to Obsolete Equipment or Standards This table describes 21 CFR requirements which are only applicable to obsolete technology. These requirements

will not be considered for product specific tables.

<Provided as a reference. Do not include this appendix in product specific table.>

21 CFR

Subchapter

J Reference

IEC Reference

Topic IEC/EPRC

Comparison


Null Null Null Null Null

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6 Appendix C – Items Included on X-Ray Inspector Tests of Diagnostic Equipment

<The information below is provided directly from CRCPD.>

The following is a list of items included on x-ray inspector equipment tests. It represents the

results of a polling of several state radiation control programs that are heavily involved in x-ray

regulation, so it should include most, if not all of the tests that could be made by state and local

x-ray inspectors.

Dental equipment

Reproducibility, kVp and timer accuracy, collimation, ESE, HVL, deadman switch, preset timer

termination, exposure at “zero” setting, technique indications, beam-on indicators, exposure

switch arrangement, SSD, processor parameters if applicable, various postings, SOPs and

trainings, film badge review, tube selection on control assembly with two or more tubes, control

assembly label (manufacturer, model #, serial #, date of manufacture), intraoral tub stability at

clinical positions, standard warning label.

Radiographic equipment

HVL, beam-on indicators, mechanical support of tube head, leakage radiation from diagnostic

source assembly, radiation from capacitor energy storage x-ray equipment in standby status,

technique indicators, exposure reproducibility, patient or film support options, personnel

protection, technique guides, patient dose parameters/ESE, patient viewing systems,

collimation, light field-rad field alignment, SID, AEC reproducibility, mA/mAs linearity, control

assembly label (manufacturer, model #, serial #, date of manufacture), badge exposure record,

standard warning label, kVp and timer accuracy, stray radiation to unrestricted areas, SOPs and

operator qualification, postings, QC in processing and viewing, repeat analysis.

Fluoroscopy equipment

HVL, AEC, kVp accuracy for both fluoroscopy mode and spot films, entrance exposure rates,

maximum exposure rates, high level control exposure rates, cine exposure rates, deadman type

exposure switch, manual reset 5 min timer, timer function, Image receptor collimation for all

sizes available, technique factor indicators, exposures linear, primary barrier intercept, barrier

transmission, buck slot cover availability if applicable, drapes or panels if applicable, shutter

function properly, beam centering, collimation for both fluoro and spot films, SSD and minimum

field size, warning labels and other required labeling, control assembly label (manufacturer,

model #, serial #, date of manufacture), PBL (if installed), QC/QA records, room shielding,

badge exposure record, SOPs and operator qualifications, “dose” or fluoro time recording for

potentially high dose procedures.

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Bone density

Personnel protection, QA/QC review, exposure indicators, control assembly label

(manufacturer, model #, serial #, date of manufacture), SOPs and operator qualifications.

CT

QA review, MSAD/CTDI measurements, slice thickness accuracy, technique factors, exposure

termination, tomo plane indications and alignment, visual/oral communication, beam on

indicators, shutter status indicator, operating procedures, operator shielding, room shielding,

control assembly label (manufacturer, model #, serial #, date of manufacture), QC/QA records,

badge exposure record, operator qualifications.

Mammography

Equivalent to MQSA requirements for physicist machine testing.

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