1、BSI Standards PublicationMedical electrical equipmentPart 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systemsBS EN 60601-2-66:2015National forewordThis British Standard is the UK implementation of EN 60601-2-66:2015. It i
2、s identical to IEC 60601-2-66:2015. It supersedes BS EN 60601-2-66:2013 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee EPL/29, Electroacoustics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This public
3、ation does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 88483 2ICS 11.180.15; 17.140.50Compliance with a British Standard cannot confer
4、 immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 December 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-2-66:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE
5、NORM EN 60601-2-66 November 2015 ICS 11.180.15; 17.140.50 Supersedes EN 60601-2-66:2013 English Version Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems (IEC 60601-2-66:2015) Apparei
6、ls lectromdicaux - Partie 2-66: Exigences particulires pour la scurit de base et les performances essentielles des instruments daudition et systmes daudition (IEC 60601-2-66:2015) Medizinische elektrische Gerte - Teil 2-66: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leis
7、tungsmerkmale von Hrgerten und Hrgertesystemen (IEC 60601-2-66:2015) This European Standard was approved by CENELEC on 2015-07-31. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national s
8、tandard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A versi
9、on 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 Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria,
10、Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
11、Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form
12、 and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-66:2015 E BS EN 60601-2-66:2015EN 60601-2-66:2015 2 European foreword The text of document 29/851/FDIS, future edition 2 of IEC 60601-2-66, prepared by IEC/TC 29 “Electroacoustics“ was submitted to the IEC-CENELEC parallel
13、 vote and approved by CENELEC as EN 60601-2-66:2015. 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) 2016-05-27 latest date by which the national standards conflicting wi
14、th the document have to be withdrawn (dow) 2018-07-31 This document supersedes EN 60601-2-66:2013. Attention is drawn to 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 pa
15、tent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European 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 t
16、his document. Endorsement notice The text of the International Standard IEC 60601-2-66:2015 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60118-4:2014 NOTE Harm
17、onized as EN 60118-4:2015 (not modified). IEC 60318-5:2006 NOTE Harmonized as EN 60318-5:2006 (not modified). IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996 (not modified). IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9. IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10. IEC 60645-1:2012 NOTE
18、Harmonized as EN 60645-1:2015 (not modified). IEC 62489-1:2010 NOTE Harmonized as EN 62489-1:2010 (not modified). ISO 80000-8:2007 NOTE Harmonized as EN ISO 80000-8:2007 (not modified). BS EN 60601-2-66:2015EN 60601-2-66:2015 3 Annex ZA (normative) Normative references to international publications
19、with their corresponding European publications The following documents, 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 docum
20、ent (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenel
21、ec.eu. Annex ZA of EN 60601-1:2006 applies except as follows: Publication Year Title EN/HD Year Replacement: IEC 60950-1 (mod) 2005 Information technology equipment - Safety - Part 1: General requirements EN 60950-1 +AC 2006 2011 +A11 2009 +A1 (mod) 2009 +A1 2010 +A12 2011 +A2 (mod) 2013 +A2 2013 Ad
22、dition: IEC 60118-0 2015 Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids EN 60118-0 2015 IEC 60118-13 - Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) EN 60118-13 - IEC 60601-1 2005 Medical electrical equipment
23、- Part 1: General requirements for basic safety and essential performance EN 60601-1 + corr. March 2006 2010 +A1 2012 +A1 +A1/AC 2013 2014 +A12 2014 BS EN 60601-2-66:2015EN 60601-2-66:2015 4 Publication Year Title EN/HD Year IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: General requi
24、rements 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 2015 IEC 62304 - Medical device software - Software life-cycle processes EN 62304 - IEC 62366 2
25、007 Medical devices - Application of usability engineering to medical devices EN 62366 2008 BS EN 60601-2-66:2015EN 60601-2-66:2015 5 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 C
26、ommission and the European Free Trade Association to provide a means of conforming to the Essential Requirements given in Annex I of the EU Directives 93/42/EEC as amended by 2007/47/EC. General Guidance: Once this standard will be cited in the Official Journal of the European Union under that Direc
27、tive, compliance with the clauses of this standard given in Table ZZ.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements (ERs) of that Directive and associated EFTA regulations. NOTE 1 This standard is intended to be a
28、pplied in its entirety only. Selected clauses or subclauses may be not applicable due to the specific type of equipment under consideration. It is necessary to understand and apply Clauses 1 to 5. It is also recommended to understand and apply those clauses which contain general requirements related
29、 to a specific subclause. Elements of the standard that are not cited in Table ZZ.1 may be relevant for the appropriate fulfilment of certain essential requirements through indirect reference, and for safety and performance aspects of the device, that are not addressed through essential requirements
30、. NOTE 2 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance to the MDD (Directive 93/42/EEC amended by 2007/47/EC). This means that risks have to be reduced “as far as possible“, “to a minimum“, “to the lowes
31、t possible level“, “minimized“ or “removed“, according to the wording of the corresponding essential requirement. NOTE 3 With respect to Note 4 of 4.2.2 General requirement for risk management, the manufacturers policy for determining acceptable risk must be in compliance with essential requirements
32、 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the directive. NOTE 4 References in the Clauses 3 to 17 or in the Annexes of this standard specify whether the normative references listed in Clause 2 as cited in Annex ZA are to be applied in whole or in part. NOTE 5 This Annex ZZ is based on Normative References
33、according to Annex ZA, replacing the references in the core text. NOTE 6 According to the scope of this standard the coverage in Table ZZ.1 only applies to the design and construction of HEARING INSTRUMENTS or HEARING INSTRUMENT SYSTEMS. This European Standard lists in Table ZZ.1 only the essential
34、requirements covered. WARNING: Other requirements and other EU Directives and Regulations may be applicable to the product(s) falling within the scope of this standard. BS EN 60601-2-66:2015EN 60601-2-66:2015 6 Table ZZ.1 Relationship between Essential Requirements of Directive 93/42/EEC amended by
35、2007/47/EC, and clauses and subclauses of this standard No. Essential Requirements Coverage of EN 60601-2-66 I. GENERAL REQUIREMENTS 1 General Guidance note 2 and 3 shall be observed 1 The devices must be designed and manufactured in such a way that, when used under the conditions and for the purpos
36、es intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the
37、patient and are compatible with a high level of protection of health and safety. This shall include: The application of EN 60601-2-66 and the documents referenced in there (below referenced as “this document” or “this standard”) support a manufacturer to design HEARING INSTRUMENTS and HEARING INSTRU
38、MENT SYSTEMS (below “devices”) in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, while accepting only risks associated wit
39、h their intended use that constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. Details and exclusions supporting this general statement follow in order of the essential requirements below. Where the inte
40、nded use of devices exceeds the scope of this document, the manufacturer may need to apply additional methods to achieve conformity to the essential requirements. Manufacturing aspects are not covered by this document! This statement applies to several essential requirements below but will not be re
41、peated at each line, in order to provide for a better usability of this document. reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and The application of this do
42、cument (201.7.1.1, 201.12.2 with reference to EN 62366) reduces, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used. BS EN 60601-2-66:2015EN 60601-2-66:2015 7 No. Essential Requirements Coverage of EN 6
43、0601-2-66 consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users). This document (201.7.9.1, 201.7.9.2.2) puts consideration of the technical knowle
44、dge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users). 2 General Guidance note 2 and 3 shall be observed 2 The solutions adopted by the manufacturer for the design and construction of
45、 the devices must conform to safety principles, taking account of the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: The requirements of this document for the design and construction o
46、f the devices conform to safety principles, taking account of the generally acknowledged state of the art at the time it has been released (2014). This document references EN ISO 14971, the application of which (4.3) does provide for the coverage of potential developments and new conclusions in hear
47、ing aid safety that became known after the release of this particular standard. The requirements of this document have been established by selecting the most appropriate solutions to the particular devices and their risks, by applying the following principles in the following order: eliminate or red
48、uce risks as far as possible (inherently safe design and construction), where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, inform users of the residual risks due to any shortcomings of the protection measures adopted. 3
49、The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer. The performance aspect (clinical evaluation) is not covered by this document unless basic safety is concerned. HEARING INSTRUMENTS do not have ESSENTIAL PERFORMANCE (201.4.3). If a manufacturer extends the intended use to safety critical functional claims, the resulting ESSENTIAL PERFOR
