IEC 60601-2-37-2007 Medical electrical equipment - Part 2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagno.pdf

1、 IEC 60601-2-37Edition 2.0 2007-08INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment Appareils lectromdicaux Partie 2-37: Exigences particu

2、lires pour la scurit de base et les performances essentielles des appareils de diagnostic et de surveillance mdicaux ultrasonsIEC60601-2-37:2007 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2007 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publicatio

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17、ONALEMedical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment Appareils lectromdicaux Partie 2-37: Exigences particulires pour la scurit de base et les performances essentielles des appare

18、ils de diagnostic et de surveillance mdicaux ultrasons INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XICS 11.040.55; 17.140.50 PRICE CODECODE PRIXISBN 2-8318-9266-X 2 60601-2-37 IEC:2007 CONTENTS FOREWORD.4 INTRODUCTION.6 201.1 Scope, object and related standar

19、ds .7 201.2 Normative references8 201.3 Terminology and definitions 8 201.4 General requirements .11 201.5 General requirements for testing ME EQUIPMENT 12 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 12 201.7 ME EQUIPMENT identification, marking and documents 12 201.8 Protection against elec

20、trical HAZARDS from ME EQUIPMENT 15 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS16 201.10 Protection against unwanted and excessive radiation HAZARDS .16 201.11 Protection against excessive temperatures and other HAZARDS .17 201.12 Accuracy of controls and instruments a

21、nd protection against hazardous outputs .21 201.13 Hazardous situations and fault conditions .22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .23 201.15 Construction of ME EQUIPMENT .23 201.16 ME SYSTEMS.23 201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 23 202.6 ELECTR

22、OMAGNETIC COMPATIBILITY .23 Annex AA (informative) Guidance and rationale for particular subclauses 26 Annex BB (informative) Guidance in classification according to CISPR 11 .31 Annex CC (informative) Guidance to the MANUFACTURER on the interpretation of TI and MI to be used to inform the OPERATOR3

23、2 Annex DD (informative) Example set-up to measure surface temperature of externally applied TRANSDUCER ASSEMBLIES .35 Bibliography38 Index of defined terms 41 Figure DD.1 Set-up of an example test object to measure the surface temperature of externally applied transducers 37 Table 201.101 List of s

24、ymbols11 Table 201.102 Distributed essential performance requirements .12 Table 201.103 Acoustic output reporting table 15 Table 201.104 Overview of the tests noted under 201.11.1.3 .20 Table CC.1 Relative importance of maintaining low exposure indices in various scanning situations .34 60601-2-37 I

25、EC:2007 3 Table DD.1 Acoustic and thermal properties of tissues any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC col

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29、 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 provides no marking procedure to indicate its approval and cannot be rendered r

30、esponsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have 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 tec

31、hnical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, 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 IE

32、C Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications 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 subj

33、ect of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-37 has been prepared by IEC subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second e

34、dition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005. The text of this particular standard is based on the following doc

35、uments: Enquiry draft Report on voting 62B/624/CDV 62B/657/RVCFull information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. 60601-2-37 IEC:2007 5 This publication has been drafted in accordance with the ISO/IEC Directiv

36、es, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type.

37、 TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 incl

38、udes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular

39、standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of th

40、is standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a p

41、ermissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published

42、under the general title: Medical electrical equipment, can be found on the IEC website The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specif

43、ic publication. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. 6 60601-2-37 IEC:2007 INTRODUCTION In this particular standard, safety requirements additional to those in the general standard are specified for ULTRASONIC DIAGNOSTIC EQUIPMENT.

44、A general guidance and rationale for the requirements of this particular standard are given in Annex AA. Knowledge of the reasons for these requirements will not only facilitate the proper application of this particular standard but will, in due course, expedite any revision necessitated by changes

45、in clinical practice or as a result of developments in technology. The approach and philosophy used in drafting this particular standard for safety of ULTRASONIC DIAGNOSTIC EQUIPMENT are consistent with those in standards of the IEC 60601-2-xx series that apply to other diagnostic modalities, such a

46、s X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the

47、 responsibility of the OPERATOR to understand the risk of the output of the ULTRASONIC DIAGNOSTIC EQUIPMENT, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the PATIENT. 60601-2-37 IEC:2007 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-37: Particular re

48、quirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment The clauses and subclauses of the general standard apply except as follows: 201.1 Scope, object and related standards Clause 1 of the general standard applies, except as follows: 201.1

49、1 *Scope Addition: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause