IEC TS 62462-2017 Ultrasonics - Output test - Guidance for the maintenance of ultrasound physiotherapy systems《超音波学.输出试验.超频率音响理疗设备的维护指南》.pdf

1、 IEC TS 62462 Edition 2.0 2017-07 TECHNICAL SPECIFICATION Ultrasonics Output test Guidance for the maintenance of ultrasound physiotherapy systems IEC TS 62462:2017-07(en) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2017 IEC, Geneva, Switzerland All rights reserved. Unless otherw

2、ise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you have any quest

3、ions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. IEC Central Office Tel.: +41 22 919 02 11 3, rue de Varemb Fax: +41 22 919 03 00 CH-1211 Geneva 20

4、infoiec.ch Switzerland www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publ

5、ications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. IEC Catalogue - webstore.iec.ch/catalogue The stand-alone application for consulting the entire bibliographical information on IEC Internation

6、al Standards, Technical Specifications, Technical Reports and other documents. Available for PC, Mac OS, Android Tablets and iPad. IEC publications search - www.iec.ch/searchpub The advanced search enables to find IEC publications by a variety of criteria (reference number, text, technical committee

7、,). It also gives information on projects, replaced and withdrawn publications. IEC Just Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available online and also once a month by email. Electropedia - www.el

8、ectropedia.org The worlds leading online dictionary of electronic and electrical terms containing 20 000 terms and definitions in English and French, with equivalent terms in 16 additional languages. Also known as the International Electrotechnical Vocabulary (IEV) online. IEC Glossary - std.iec.ch/

9、glossary 65 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002. Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR. IEC Customer Service Centre - webstore.iec.ch/c

10、sc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csciec.ch. IEC TS 62462 Edition 2.0 2017-07 TECHNICAL SPECIFICATIONUltrasonics Output test Guidance for the maintenance of ultrasound physiotherapy systems INTERNATIONA

11、L ELECTROTECHNICAL COMMISSION ICS 11.040.60;17.140.50 ISBN 978-2-8322-4561-3 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. colour inside 2 IEC TS 62462:2017 IEC 2017 CONTENTS FOREWORD . 4 IN

12、TRODUCTION . 6 1 Scope 7 2 Normative references 7 3 Terms and definitions 7 4 Testing regimes . 9 4.1 Acceptance testing 9 4.2 Weekly testing 9 4.3 Annual testing . 9 5 Performance testing 9 5.1 Acceptance testing 9 5.1.1 General . 9 5.1.2 Visual inspection . 9 5.1.3 Manufacturers statement 9 5.1.4

13、Ultrasonic output test . 9 5.1.5 Beam uniformity and output test 10 5.1.6 Recording of results of acceptance test . 11 5.1.7 Requirements and recommendation . 11 5.2 Weekly testing 11 5.2.1 General . 11 5.2.2 Visual inspection . 11 5.2.3 Relative ultrasonic output test 11 5.2.4 Beam uniformity and o

14、utput test 11 5.2.5 Recording of results of weekly testing 11 5.2.6 Requirements and recommendation . 11 5.3 Annual testing . 11 5.3.1 General . 11 5.3.2 Output power test 12 5.3.3 Effective radiating area 12 5.3.4 Beam uniformity test 12 5.3.5 Pulse duty factor accuracy test 12 5.3.6 Timer accuracy

15、 test . 13 5.3.7 Recording of results of annual testing 13 5.4 Service requirement 13 (informative) Rationale for testing 15 Annex A A.1 Acceptance testing 15 A.2 Weekly testing 15 A.3 Annual testing . 15 (informative) Guidance for testers 16 Annex B B.1 Ultrasound power meter specifications 16 B.2

16、Room and water temperature 17 B.3 Water 17 B.4 Environmental considerations . 17 B.5 Ultrasound power meter checks 17 B.6 Ultrasound power meter testing technique 17 IEC TS 62462:2017 IEC 2017 3 (informative) Quantitative relative ultrasonic output test using temperature Annex C rise 19 (informative

17、) Quantitative relative ultrasonic output test using calorimetry . 21 Annex D(informative) Qualitative test to assess changes of effective radiating area 23 Annex E(informative) Example of weekly test report 25 Annex F(informative) Example of annual test report . 26 Annex G Bibliography 30 Figure 1

18、Several examples of how to prepare a set-up to check the distortion on the water surface due to ultrasound 14 Figure 2 Set-up where the slight angle of the treatment head to the vertical may improve the image 14 Figure C.1 Example of a measurement set-up to measure the temperature rise due to ultras

19、ound in absorbing material . 20 Figure D.1 Schematic of equipment used within the calorimeter method for monitoring power output of therapy treatment heads . 21 Figure E.1 Assessing changes of the effective radiating area using a thermochromic phantom . 24 Figure E.2 Examples of different patterns o

20、bserved during an experiment using a thermochromic phantom made of silicon . 24 Figure G.1 Example of a power calibration graph for two large applicator heads 28 Figure G.2 Example of a power calibration graph for two small applicator heads 29 4 IEC TS 62462:2017 IEC 2017 INTERNATIONAL ELECTROTECHNI

21、CAL COMMISSION _ ULTRASONICS OUTPUT TEST GUIDANCE FOR THE MAINTENANCE OF ULTRASOUND PHYSIOTHERAPY SYSTEMS FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The

22、 object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifi

23、cations (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations

24、liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters ex

25、press, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Comm

26、ittees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC Natio

27、nal Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does

28、not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have

29、 the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoe

30、ver, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publicati

31、ons is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC

32、technical committees is to prepare International Standards. In exceptional circumstances, a technical committee may propose the publication of a technical specification when the required support cannot be obtained for the publication of an International Standard, despite repeated efforts, or the sub

33、ject is still under technical development or where, for any other reason, there is the future but no immediate possibility of an agreement on an International Standard. Technical specifications are subject to review within three years of publication to decide whether they can be transformed into Int

34、ernational Standards. IEC TS 62462, which is a Technical Specification, has been prepared by IEC technical committee 87: Ultrasonics. This second edition cancels and replaces the first edition published in 2007. This edition constitutes a technical revision. IEC TS 62462:2017 IEC 2017 5 This edition

35、 includes the following significant technical changes with respect to the previous edition: addition of a novel method for periodic testing regarding possible changes of the effective radiating area using thermochromic absorbers in a new Annex E; The text of this Technical Specification is based on

36、the following documents: Enquiry draft Report on voting 87/640/DTS 87/647A/RVDTS Full information on the voting for the approval of this technical specification can be found in the report on voting indicated in the above table. This document has been drafted in accordance with the ISO/IEC Directives

37、, Part 2. In this document, the following print types are used: requirements: in roman type; notes: in small roman type; words in bold in the text are defined in Clause 3. The committee has decided that the contents of this document will remain unchanged until the stability date indicated on the IEC

38、 website under “http:/webstore.iec.ch“ in the data related to the specific document. At this date, the document will be reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later date. IMPORTANT The colour inside logo on the co

39、ver page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this document using a colour printer. 6 IEC TS 62462:2017 IEC 2017 INTRODUCTION The purpose of this document is to establish s

40、tandard methods for a qualitative check of the performance of ultrasound physiotherapy devices during their lifetime, and to provide guidance on calibration requirements and techniques. To ensure that the ultrasound physiotherapy equipment is in an appropriate condition for use, a regular quality ch

41、eck can be performed. This document defines acceptance, weekly and annual checks. The acceptance test checks the delivery of the device and its performance at the start of its lifetime. The weekly check is a simple qualitative check of device operation. In the annual check, in addition to a qualitat

42、ive check, a quantitative check is defined. Examples are provided of weekly and annual test reports. This document also gives guidance to the testers concerning the measurement of acoustic output. Annual testing may be performed by a skilled tester, e.g. biomedical engineer, medical physicist, medic

43、al device service agent, commercial tester, test house, national measurement institute or manufacturer. IEC TS 62462:2017 IEC 2017 7 ULTRASONICS OUTPUT TEST GUIDANCE FOR THE MAINTENANCE OF ULTRASOUND PHYSIOTHERAPY SYSTEMS 1 Scope This document, which is a Technical Specification, describes methods m

44、eant to assist users of ultrasound physiotherapy systems in checking the performance of such systems. It is applicable primarily to physiotherapists, general medical practitioners, chiropractors, osteopaths, beauty therapists, sports professionals, biomedical engineers, medical physicists, medical d

45、evice service agents, commercial testers, test houses or manufacturers. Typical ultrasound physiotherapy systems operate in the range from 0,5 MHz to 5 MHz. Long-wave ultrasound therapy machines operating in the frequency range 30 kHz to 0,5 MHz are not covered by this document. 2 Normative referenc

46、es The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) app

47、lies. NOTE The titles of all publications referred to informatively in this document are listed in the Bibliography. IEC 60601-2-5:2009, Medical electrical equipment Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment IEC 61161:2013,

48、 Ultrasonics Power measurement Radiation force balances and performance requirements IEC 61689:2013, Ultrasonics Physiotherapy systems Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz 3 Terms and definitions For the purposes of this document, the following term

49、s and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp NOTE Most of the definitions in Clause 3 are taken from existing IEC standards. They have been simplified for the purposes of this document. 3.1 acoustic working frequency rate at which the treatment heads contact f