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
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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
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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
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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
