EN 60601-2-66-2013 0625 Medical electrical equipment - Part 2-66 Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrumen.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systemsBS EN 60601-2-6

2、6:2013Copyright European Committee for Electrotechnical Standardization Provided by IHS under license with CENELECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-National forewordThis British Standard is the UK implementation of EN 60601-2-66:2013. It isidentical t

3、o IEC 60601-2-66:2012.The UK participation in its preparation was entrusted to Technical CommitteeEPL/29, Electroacoustics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of aco

4、ntract. Users are responsible for its correct application. The British Standards Institution 2013Published by BSI Standards Limited 2013ISBN 978 0 580 74148 7ICS 11.180.15; 17.140.50Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published un

5、der the authority of the StandardsPolicy and Strategy Committee on 28 February 2013.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 60601-2-66:2013Copyright European Committee for Electrotechnical Standardization Provided by IHS under license with CENELECNot for R

6、esaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD EN 60601-2-66 NORME EUROPENNE EUROPISCHE NORM January 2013 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnis

7、che Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-66:2013 E ICS 11.180.15; 17.140.50 English version Medical electrical equipment - Part 2-66: Particula

8、r requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems (IEC 60601-2-66:2012) Appareils lectromdicaux - Partie 2-66: Exigences particulires pour la scurit de base et les performances essentielles des instruments daudition et systmes dauditi

9、on (CEI 60601-2-66:2012) Medizinische elektrische Gerte - Teil 2-66: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Hrgerten und Hrgertesystemen (IEC 60601-2-66:2012) This European Standard was approved by CENELEC on 2012-11-06. CENELEC members are boun

10、d to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CE

11、N-CENELEC Management Centre or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management

12、Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland,

13、Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 60601-2-66:2013Copyright European Committee for Electrotechnical Standardization Provided by IHS under license with CE

14、NELECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN 60601-2-66:2013 - 2 - Foreword The text of document 29/777/FDIS, future edition 1 of IEC 60601-2-66, prepared by IEC/TC 29 “Electroacoustics“ was submitted to the IEC-CENELEC parallel vote and approved by CENE

15、LEC as EN 60601-2-66:2013. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2013-08-06 latest date by which the national standards conflicting with the document have to be

16、 withdrawn (dow) 2015-11-06 This standard is to be read in conjunction with EN 60601-1:2006. 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, exampl

17、es and references: in smaller type. Normative text of tables is also in a smaller type. - 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 numbere

18、d divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes 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

19、term “Clause” followed by the clause number. References to subclauses within this particular 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 co

20、nform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this 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

21、recommended but is not mandatory for compliance with this standard; - “may” is used to describe a permissible 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

22、rationale related to that item in Annex AA. BS EN 60601-2-66:2013Copyright European Committee for Electrotechnical Standardization Provided by IHS under license with CENELECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- 3 - EN 60601-2-66:2013 Attention is drawn t

23、o the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the Europe

24、an Free Trade Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-66:2012 was approved by CENELEC as

25、a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60118-4:2006 NOTE Harmonised as EN 60118-4:2006 (not modified). IEC 60318-5:2006 NOTE Harmonised as EN 60318-5:2006 (not modified). IEC 60601

26、-1-4:1996 NOTE Harmonised as EN 60601-1-4:1996 (not modified). IEC 60645-1:2001 NOTE Harmonised as EN 60645-1:2001 (not modified). IEC 61672-1:2002 NOTE Harmonised as EN 61672-1:2003 (not modified). IEC 62489-1:2010 NOTE Harmonised as EN 62489-1:2010 (not modified). ISO 80000-8:2007 NOTE Harmonised

27、as EN ISO 80000-8:2007 (not modified). BS EN 60601-2-66:2013Copyright European Committee for Electrotechnical Standardization Provided by IHS under license with CENELECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN 60601-2-66:2013 - 4 - Annex ZA (normative) Nor

28、mative references to international publications with their corresponding European publications Annex ZA of EN 60601-1:2006 applies, except as follows: In Annex ZA of EN 60601-1:2006 replace the introductory paragraph by the following: The following documents, in whole or in part, are normatively ref

29、erenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modif

30、ications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year In Annex ZA of EN 60601-1:2006 replace IEC 60950-1:2001 by: IEC 60950-1 (mod) + corr. August 2005 2006 Information technology equipment - Safety - Part 1: General requirements EN 60950-1 + AC:2011 + A11 + A12

31、 2006 2011 2009 2011 Add to Annex ZA of EN 60601-1:2006 the following new references: IEC 60065 (mod) + corr. August 2001 2002 Audio, video and similar electronic apparatus - Safety requirements EN 60065 + corr. August + A11 + A12 2002 2007 2008 2011 IEC 60118-7 2005 Electroacoustics - Hearing aids

32、- Part 7: Measurement of the performance characteristics of hearing aids for production, supply and delivery quality assurance purposes EN 60118-7 2005 IEC 60118-13 - Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) EN 60118-13 - IEC 60601-1-11 + corr. April 2010 2011 M

33、edical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN 60601-1-11 2010 IEC 62304 - Medical device software

34、- Software life-cycle processes EN 62304 - IEC 62366 2007 Medical devices - Application of usability engineering to medical devices EN 62366 2008 BS EN 60601-2-66:2013Copyright European Committee for Electrotechnical Standardization Provided by IHS under license with CENELECNot for ResaleNo reproduc

35、tion or networking permitted without license from IHS-,-,- 5 - EN 60601-2-66:2013 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association an

36、d within its scope the standard covers all relevant essential requirements as given in Annex I of the EU Directive 93/42/EEC except the following: Essential Requirements 1 to 7.1 Essential Requirement 7.4 Essential Requirement 7.5, Paragraphs 2 and 3 Essential Requirement 13.6 (q) Compliance with th

37、is standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. BS EN 60601-2-66:2013Copyright European Committee for El

38、ectrotechnical Standardization Provided by IHS under license with CENELECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- 2 60601-2-66 IEC:2012 CONTENTS INTRODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references 8 201.3 Terms and defi

39、nitions 9 201.4 General requirements 10 201.5 General requirements for testing ME EQUIPMENT . 11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 12 201.7 ME EQUIPMENT identification, marking and documents 13 201.8 *Protection against electrical HAZARDS from ME EQUIPMENT 18 201.9 *Protection agai

40、nst MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 21 201.10 Protection against unwanted and excessive radiation HAZARDS 23 201.11 *Protection against excessive temperatures and other HAZARDS 23 201.12 *Accuracy of controls and instruments and protection against hazardous outputs 24 201.13 *HAZ

41、ARDOUS SITUATIONS and fault conditions . 25 201.14 *PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 28 201.15 *Construction of ME EQUIPMENT 28 201.16 *ME SYSTEMS . 30 201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 31 Annexes . 32 Annex E (informative) Examples of the connection

42、of the measuring device (MD) for measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 32 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures 32 Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentation 32 Annex

43、I (informative) ME SYSTEMS aspects . 32 Annex J (informative) Survey of insulation paths 33 Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams 33 Annex L (normative) Insulated winding wires for use without interleaved insulation 33 Annex AA (informative) Particular guidance and ration

44、ale 34 Annex BB (informative) Abbreviations 39 Bibliography 40 Index of defined terms used in this particular standard 41 Figure 201.101 Measuring circuit for the LEAKAGE CURRENT 20 Table 201.102 MECHANICAL HAZARDS to be considered . 21 Table AA.101 Summary of the approach of this standard . 35 BS E

45、N 60601-2-66:2013Copyright European Committee for Electrotechnical Standardization Provided by IHS under license with CENELECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-60601-2-66 IEC:2012 5 INTRODUCTION In 1998 the HEARING INSTRUMENT industry represented by th

46、e EHIMA attempted to establish a standard with the main purpose of providing manufacturers with a guide to demonstrate conformity with the European Medical Devices Directive 93/42/EEC. The document prEN 50220 failed CENELEC vote and was published as “EHIMA standard” in June 1998 with almost identica

47、l content. EHIMA concluded in 2009 that the requirements of that standard were no longer up to date and an internationally accepted standard for HEARING INSTRUMENT safety published by IEC or ISO to demonstrate compliance with regulatory requirements should be produced. This resulting IEC standard am

48、ends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment Part 1: General requirements for safety and essential performance, hereinafter referred to as the general standard. Figures in square brackets refer to the Bibliography. BS EN 60601-2-66:2013Copyright European Committee for Electrotechnical Standardization Provided by IHS under license with CENELECNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- 6 60601-2-66 IEC:2012 MEDICAL ELECTRICAL EQUIPMENT Part 2-66: Particular requiremen