IEC TR 62809-2013 Summary of requirements and tests to products in the scope of IEC 60601-2-66《IEC 60601-2-66标准范围内产品的试验和要求摘要》.pdf

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1、 IEC/TR 62809 Edition 1.0 2013-01 TECHNICAL REPORT Summary of requirements and tests for products in the scope of IEC 60601-2-66 IEC/TR 62809:2013(E) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2013 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publi

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8、 Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csciec.ch. IEC/TR 62809 Edition 1.0 2013-01 TECHNICAL REPORT Summary of requirements and tests for products in the scope of IEC 60601

9、-2-66 INTERNATIONAL ELECTROTECHNICAL COMMISSION Q ICS 11.180.15; 17.140.50 PRICE CODE ISBN 978-2-83220-618-8 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. 2 TR 62809 IEC:2013(E) CONTENTS FOR

10、EWORD . 3 INTRODUCTION . 5 1 Scope . 6 2 Normative references . 6 3 Summary of requirements and tests . 6 Bibliography 17 Table 1 Summary of requirements and tests 7 TR 62809 IEC:2013(E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ SUMMARY OF REQUIREMENTS AND TESTS FOR PRODUCTS IN THE SCOPE OF IEC

11、60601-2-66 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 questions concerning standardiza

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14、nternational 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 express, as nearly as possible, an international consensus of opinion on the relevant subjects si

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18、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 the latest edition of this publication. 7) No liability shall attach to IEC or its directors,

19、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 whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out o

20、f 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 publications is indispensable for the correct application of this publication. 9) Attention is drawn to

21、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 technical committees is to prepare International Standards. However, a technical committee may

22、propose the publication of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC 62809, which is a technical report, has been prepared by IEC technical committee 29: Electroacoustics.

23、The text of this technical report is based on the following documents: Enquiry draft Report on voting 29/776/DTR 29/791/RVC Full information on the voting for the approval of this technical report can be found in the report on voting indicated in the above table. This publication has been drafted in

24、 accordance with the ISO/IEC Directives, Part 2. 4 TR 62809 IEC:2013(E) In this standard, the following print types are used: requirements and definitions: roman type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. The committee has decide

25、d that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended.

26、 A bilingual version of this publication may be issued at a later date. TR 62809 IEC:2013(E) 5 INTRODUCTION During the preparation of IEC 60601-2-66, members of the involved technical committee and working group voiced concerns about the complexity of the document and its structure as part of the IE

27、C 60601 series. Members felt distracted from the technical content by this complexity during reviews of the document stages. There was also concern that groups in the hearing instrument community would have problems to understand and apply the standard and that this could be an issue with its accept

28、ability. In order to have a broad consensus for the new standard it was agreed that the standard should be supported by this Technical Report, which should enable members of the community and the industry to have a basic understanding of the requirements of the standard, without the need to study th

29、e complete standard document and the documents that are referenced in it. IEC 60601-2-66 was published to address the specific requirements for safety of hearing instruments, and it is entitled “Particular requirements for the basic safety and essential performance of hearing instruments and hearing

30、 instruments systems”. It was published because IEC 60601-1 is a general standard intended to address a wide range of medical electrical equipment including large scale facilities such as MRI machines, for example and thus has large sections that are not relevant to low-voltage, low power, subminiat

31、ure hearing instruments. If IEC 60601-2-66 was not published, test and regulatory organizations would probably have difficulty applying IEC 60601-1, because it does not contain specific guidance for hearing instruments. This Technical Report contains all the requirements from IEC 60601-2-66 which re

32、late to hearing instruments, and reduces discussion with those that do not relate to hearing instruments. It includes specific references to the applicable requirements within IEC 60601-1, and it is suggested that hearing instrument designers and manufacturers along with test and regulatory organiza

33、tions read this Technical Report as an overview of IEC 60601-2-66. 6 TR 62809 IEC:2013(E) SUMMARY OF REQUIREMENTS AND TESTS FOR PRODUCTS IN THE SCOPE OF IEC 60601-2-66 1 Scope This Technical Report provides an overview of the requirements and tests of IEC 60601-2-66 in combination with the applicabl

34、e sections of IEC 60601-1, and the collateral standards of the IEC 60601 series. NOTE The IEC 60601 series consists of three levels of standards: IEC 60601-1, known as the general standard, several IEC 60601-1-X documents, known as the collateral standards and a series of particular standards coveri

35、ng requirements for specific types of equipment (IEC 60601-2-X). It is intended to assist various groups involved in the product lifecycles process like designers and suppliers to get an overview of the basic requirements without studying all involved standard documents in detail. The table includes

36、 not all but just the more common requirements and tests. It is crucial to understand that the summary in this document cannot serve as an input for a product requirement specification or as a test plan without consulting the standard document itself. This Technical Report alone cannot be used to es

37、tablish or assess compliance to the standard. The summary in Table 1 below does not preclude the user from reading the referenced standards in their entirety for a thorough knowledge of the basic safety of hearing instruments and hearing instrument systems. 2 Normative references The following docum

38、ents, in whole or in part, are normatively referenced 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. IEC 60601-1:2005, Medical

39、electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-2-66:2012, Medical electrical equipment Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems 3 Summary of requirem

40、ents and tests The reference column in Table 1 shows the clause number of IEC 60601-2-66:2012 and, if applicable the reference to IEC 60601-1:2005, or other documents. References to the particular standard, IEC 60601-2-66:2012 start with the number 201, while references to the general standard, IEC

41、60601-1:2005, start directly with the clause or subclause number. Other documents will be referred to explicitly. Some detailed references, for example describing tools, are placed in the text instead of in the reference column. TR 62809 IEC:2013(E) 7 Table 1 Summary of requirements and tests Refere

42、nce Subject Requirements and tests 201.1.1 201.8 ACCESSORY Requirements: ACCESSORIES to HEARING INSTRUMENTS (e.g. remote control units, audio streamers, battery chargers, power supplies) need to have documented proof of compliance to IEC 60065, IEC 60950-1, the IEC 60601-1 or other applicable IEC sa

43、fety standards. They form a HEARING INSTRUMENT SYSTEM when connected to the HEARING INSTRUMENT. Wherever this connection has an influence on the compliance to the requirements of IEC 60601-2-66 the HEARING INSTRUMENT has to pass the requirements while being connected to the ACCESSORY. If this connec

44、tion results in additional requirements to the ACCESSORY, these requirements have to be fulfilled beyond the applicable IEC standards. Programming interfaces or ACCESSORIES in a clinical application are covered by IEC 60601. For HEARING INSTRUMENTS that are supplied by an external power source: If a

45、 particular separate power supply is specified then the relevant tests are performed with the HEARING INSTRUMENTS connected to it. If a generic separate power supply is specified, then the specification in the ACCOMPANYING DOCUMENTS is inspected. Tests: Inspection of ACCESSORY documentation, test co

46、nfiguration 201.4.1 201.4 4 5 TYPE TESTS TYPE TESTS are performed on a representative sample of the item being tested. If multiple products are under consideration, which have a similar mechanical and electrical architecture, then an engineering analysis by the MANUFACTURER may justify a single repr

47、esentative sample for a family of products. Testing conditions shall consider not just NORMAL USE but also reasonably foreseeable misuse. Misuse and faults shall be the subject and results of the RISK ANALYSIS. The instructions for use have to be considered in testing conditions. The equipment is te

48、sted under the least favourable working conditions. 4.2 4.5 ISO 14971 RISK MANAGEMENT Requirements: A RISK MANAGEMENT complying with ISO 14971 shall be performed. Where IEC 60601-2-66 specifies requirements addressing particular RISKS, alternative means of addressing these RISKS are acceptable provi

49、ded that the MANUFACTURER can justify that the RESIDUAL RISKS are the same or lower. Tests: Inspection of the RISK MANAGEMENT FILE 4.4 EXPECTED SERVICE LIFE Requirements: The MANUFACTURER shall state the EXPECTED SERVICE LIFE of the HEARING INSTRUMENT in the RISK MANAGEMENT FILE. Tests: Inspection of the RISK MANAGEMENT FILE 4.8 4.9 Components Requirements: Components, the failure of which could result in a HAZARDOUS SITUATION shall be used in accordance with their specified ratings. The reliability of co