Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.

इंटरनेट मानक

“!ान $ एक न' भारत का +नम-ण”Satyanarayan Gangaram Pitroda

“Invent a New India Using Knowledge”

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“Step Out From the Old to the New”

“जान1 का अ+धकार, जी1 का अ+धकार”Mazdoor Kisan Shakti Sangathan

“The Right to Information, The Right to Live”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता है”Bhartṛhari—Nītiśatakam

“Knowledge is such a treasure which cannot be stolen”

“Invent a New India Using Knowledge”

है”ह”ह

IS 13450-2-5 (2009): Medical Electrical Equipment, Part 2:Particular Requirements for the Safety, Section 5:Ultrasonic Physiotherapy Equipment [MHD 14: HospitalPlanning]

IS 13450 (Part 2/Sec 5) : 2009IEC 60601-2-5 : 2005[Superseding IS 13020 (Part 1) : 1991and IS 13020 (Part 2) : 1990]

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Indian StandardMEDICAL ELECTRICAL EQUIPMENTPART 2 PARTICULAR REQUIREMENTS FOR THE SAFETY

Section 5 Ultrasonic Physiotherapy Equipment

ICS 11.040.60

© BIS 2009

B U R E A U O F I N D I A N S T A N D A R D SMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

December 2009 Price Group 7

Electromedical Equipment Sectional Committee, MHR 15

NATIONAL FOREWORD

This Indian Standard (Part 2/Sec 5) which is identical with IEC 60601-2-5 : 2005 ‘Medical electrical equipment— Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment’ issued by theInternational Electrotechnical Commission (IEC) was adopted by the Bureau of Indian Standards on therecommendation of the Electromedical Equipment Sectional Committee and approval of the Medical Equipmentand Hospital Planning Division Council.

This standard was earlier published in two parts as IS 13020 (Part 1) : 1991 ‘Medical electrical equipment —Ultrasonic physiotherapy equipment: Part 1 Particular requirements for safety’ and IS 13020 (Part 2) : 1990‘Medical electrical equipment — Ultrasonic physiotherapy equipment: Part 2 Constructional and performancerequirements’, as technically equivalent standards based on IEC 60601-2-5 : 1984. This adoption has beentaken to harmonize with the latest IEC Publication. This standard incorporates both the safety requirementsas well as constructional requirements. With the publication of this standard IS 13020 (Part 1) : 1991 and IS13020 (Part 2) : 1990 shall be treated as superseded and hence withdrawn.

This particular standard specifies requirements and tests for the safety of ultrasonic physiotherapy equipment.This particular standard supplements the General Standard IS 13450 (Part 1) : 2008 ‘Medical electricalequipment — Part 1: General requirements for the basic safety and essential performance (first revision)’.The requirements of this particular standard take priority over those of the General Standard.

This standard incorporates additional clauses on electro-magnetic compatibility, homogeneity of the radiationfield and output stability with time. The specified accuracy has been changed from ±30 percent to ±20percent in order to provide an adequate degree of safety. Accuracy of the timer has been specified for timersettings of less than 5 min, 5 min to 10 min and more than 10 min. Additional items has been included in‘instructions for use’ clause, for example, intervals for regular performance testing and calibration by theuser, a list of conditions for which ultrasound treatment is contra indicated, a statement of intended use(s),information on available treatment head, method by which interchangeability is achieved, in case the treatmenthead has been designed for interchangeability.

A rationale for the more important requirements, where appropriate, is given in Annex AA. It is consideredthat a knowledge of the reasons for these requirements will not only facilitate the proper application of thisparticular standard but will, in due course, expedite any revision necessitated by changes in clinical practiceor as a result of developments in technology. However, this annex does not form part of the requirements ofthis standard.

The text of IEC Standard has been approved as suitable for publication as an Indian Standard withoutdeviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention isparticularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as‘Indian Standard’.

b) Comma (,) has been used as a decimal marker in the International Standard while in Indian Standards,the current practice is to use a point (.) as the decimal marker.

In this adopted standard, reference appears to certain International Standards for which Indian Standardsalso exist. The corresponding Indian Standards which are to be substituted in their respective places arelisted below, along with their degree of equivalence, for the editions indicated:

(Continued on third cover)

Corresponding Indian Standard

IS 13450 (Part 1) : 2008 Medicalelectrical equipment: Part 1 Generalrequirement for the basic safety andessential performance (first revision)

International Standard

IEC 60601-1 : 19881) Medical electricalequipment — Part 1: Generalrequirement for safety

1)Since revised in 2005.

Degree of Equivalence

Technically Equivalent

Indian StandardMEDICAL ELECTRICAL EQUIPMENTPART 2 PARTICULAR REQUIREMENTS FOR THE SAFETY

Section 5 Ultrasonic Physiotherapy Equipment

1

15

NATIONAL ANNEX A(National Foreword)

A-1 BIS CERTIFICATION MARKING

The product may also be marked with the Standard Mark.

A-1.1 The use of the Standard Mark is governed by the provisions of the Bureau of Indian Standards Act,1986 and the Rules and Regulations made thereunder. The details of conditions under which the licence forthe use of the Standard Mark may be granted to manufacturers or producers may be obtained from theBureau of Indian Standards.

IS 13450 (Part 2/Sec 5) : 2008IEC 60601-2-5 : 2005

16

(Continued from second cover)

The technical committee responsible for the preparation of this standard has reviewed the provisions of thefollowing International Standards referred in this adopted standard and has decided that they are acceptablefor use in conjunction with this standard:

International Standard Title

IEC 60050 (801) : 1994 International Electrotechnical Vocabulary — Chapter 801: Acoustics andelectroacoustics

IEC 60469-1 : 1987 Pulse techniques and apparatus — Part 1: Pulse terms and definitions

IEC 60601-1-2 : 19932) Medical electrical equipment — Part 1: General requirements for safety —Section 2 — Collateral Standard: Electromagnetic compatibility — Requirementsand tests

IEC 60601-2-36 : 1997 Medical electrical equipment — Part 2-36: Particular requirements for the safetyof equipment for extracorporeally induced lithotripsy

IEC 61102 : 19913) Measurement and characterization of ultrasonic fields using hydrophones inthe frequency range 0.5 MHz to 15 MHz

IEC 61161 : 19924) Ultrasonics — Power measurement — Radiation force balances and performancerequirements

IEC 61689 : 19962) Ultrasonics — Physiotherapy systems — Performance requirements andmethods of measurement in the frequency range 0.5 MHz to 5 MHz

Only the English language text of the International Standard has been retained while adopting it in this IndianStandard, and as such the page numbers given here are not the same as in the IEC publication.

The standard also makes a reference to the BIS Certification Marking of the product, details of which isgiven in National Annex A.

For the purpose of deciding whether a particular requirement of this standard is complied with, the finalvalue, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordancewith IS 2 : 1960 ‘Rules for rounding off numerical values (revised)’. The number of significant places retainedin the rounded off value should be the same as that of the specified value in this standard.

International Standard Corresponding Indian Standard Degree of Equivalence

Technically Equivalent

do

IEC 60601-1-1 : 19921) Medicalelectrical equipment — Part1: Generalrequirements for safety — Section 1— Collateral Standard : Safetyrequirements for medical electricalsystems

IEC 60601-1-4 : 19961) Medicalelectrical equipment — Part 1: Generalrequirements for safety — 4. CollateralStandard: Programmable electricalmedical systems

IS 13450 (Part 1/Sec 1) : 2006 Medicalelectrical equipment: Part 1 Generalrequirement for safety, Section 1Collateral Standard: Safetyrequirements for medical electricalsystems

IS 13450 (Part 1/Sec 4) : 2008 Medicalelectrical equipment: Part 1 Generalrequirements for safety, Section 4Collateral Standard: Programmableelectrical medical systems

1) Since revised in 2000.2) Since revised in 2007.3) This IEC has been replaced by IEC 62127-1 : 2007, IEC 62127-2 : 2007 and IEC 62127-3 : 2007.4) Since revised in 2006.

Bureau of Indian Standards

BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promoteharmonious development of the activities of standardization, marking and quality certification of goodsand attending to connected matters in the country.

Copyright

BIS has the copyright of all its publications. No part of these publications may be reproduced in any formwithout the prior permission in writing of BIS. This does not preclude the free use, in course of imple-menting the standard, of necessary details, such as symbols and sizes, type or grade designations.Enquiries relating to copyright be addressed to the Director (Publications), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards are alsoreviewed periodically; a standard along with amendments is reaffirmed when such review indicates thatno changes are needed; if the review indicates that changes are needed, it is taken up for revision. Usersof Indian Standards should ascertain that they are in possession of the latest amendments or edition byreferring to the latest issue of ‘BIS Catalogue’ and ‘Standards: Monthly Additions’.

This Indian Standard has been developed from Doc No.: MHR 15 (0092).

Amendments Issued Since Publication______________________________________________________________________________________

Amendment No. Date of Issue Text Affected______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

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