IEC 60601-2-66-2015 Medical electrical equipment - Part 2-66 Particular requirements for the basic safety and essential performance of hearing instruments and h.pdf

1、 IEC 60601-2-66 Edition 2.0 2015-06 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems Appareils lectromdicaux Partie 2-66: Exigences particul

2、ires pour la scurit de base et les performances essentielles des instruments daudition et systmes daudition IEC 60601-2-66:2015-06(en-fr) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2015 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may b

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20、NATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems Appareils lectromdicaux Partie 2-66: Exigences particulires pour la scurit de base et les perfor

21、mances essentielles des instruments daudition et systmes daudition INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.180.15; 17.140.50 ISBN 978-2-8322-2766-4 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission

22、Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 IEC 60601-2-66:2015 IEC 2015 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, ob

23、ject and related standards 6 201.2 Normative references 8 201.3 Terms and definitions 8 201.4 General requirements 10 201.5 General requirements for testing ME EQUIPMENT 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12 201.7 ME EQUIPMENT identification, marking and documents . 13 201.8 *P

24、rotection against electrical HAZARDS from ME EQUIPMENT 18 201.9 *Protection against 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

25、controls and instruments and protection against hazardous outputs . 24 201.13 *HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25 201.14 *PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28 201.15 *Construction of ME EQUIPMENT 29 201.16 *ME SYSTEMS . 31 201.17 *Electromagnetic compatibi

26、lity of ME EQUIPMENT and ME SYSTEMS 31 Annexes . 32 Annex E (informative) Examples of the connection 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 mixtur

27、es . 32 Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentation 32 Annex I (informative) ME SYSTEMS aspects 32 Annex J (informative) Survey of insulation paths . 32 Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams 33 Annex L (normative) Insulated winding

28、wires for use without interleaved insulation . 33 Annex AA (informative) Particular guidance and rationale . 34 Annex BB (informative) Abbreviations 39 Bibliography . 40 Index of defined terms used in this particular standard 41 Figure 201.101 Measuring circuit for LEAKAGE CURRENT . 20 Table 201.102

29、 MECHANICAL HAZARDS to be considered 21 Table AA.101 Summary of the approach of this standard 35 IEC 60601-2-66:2015 IEC 2015 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-66: Particular requirements for the basic safety and essential performance of hearing instru

30、ments and hearing instrument systems FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questi

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40、 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. International Standard IEC 60601-2-66 has been prepared by IEC technical committee 29: Ele

41、ctroacoustics. This second edition cancels and replaces the first edition published in 2012. It constitutes a technical revision to adapt IEC 60601-2-66:2012 to the technical corrections introduced by Amendment 1 (2012) to IEC 60601-1:2005, as well as to clarify and correct the wording of this parti

42、cular standard and to implement minor changes requested by interested parties. The text of this standard is based on the following documents: FDIS Report on voting 29/851/FDIS 29/869/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated i

43、n the above table. 4 IEC 60601-2-66:2015 IEC 2015 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outs

44、ide of tables, such as notes, examples 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” me

45、ans one of the seventeen numbered 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

46、 standard are preceded by the 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

47、forms used in this standard conform 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

48、 requirement or a test is 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 th

49、at there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published 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 stability date indicated on the IEC website under “http:/webstore.iec.ch“ in the data related to the specific publication. A