EN 60601-1-6-2010 en Medical electrical equipment - Part 1-6 General requirements for basic safety and essential performance - Collateral standard Usability (Incorporates Amendment.pdf

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1、BSI Standards PublicationMedical electrical equipmentPart 1-6: General requirements for basic safety and essential performance Collateral standard: UsabilityBS EN 60601-1-6:2010+A1:2015National forewordThe UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equ

2、ipment in Medical Practice, to Subcommittee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a con

3、tract. Users are responsible for its correct application.ISBN 978 0 580 77963 3ICS 11.040.01Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards P o l i c y a n d S t r a t e g y C o m m i t t e e o

4、n 3 1 M a y 2 0 1 0 .A m e n d m e n t s / c o r r i g e n d a i s s u e d s i n c e p u b l i c a t i o nDate T e x t a f f e c t e dBRITISH STANDARDBS EN 60601-1-6:2010+A1:2015This British Standard is the UK implementation of EN 60601-1-6:2010+A1:2015. It is identical to IEC 60601-1-6:2010, incorp

5、orating amendment 1:2013. It supersedes BS EN 60601-1-6:2010, which will be withdrawn on 31 December 2018.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text alt

6、ered by IEC amendment 1 is indicated by . !“. The British Standards Institution 2015.Published by BSI Standards Limited 201531 July 2015 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2015. Annexes ZA and ZZ updatedEUROPEAN STANDARD EN 60601-1-6:2010+A1NORME EUROPENNE EUROPISCHE

7、NORMC E N E L E C European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische NormungC ent r a l S e c r et a r ia t: Av en u e M ar ni x 17 , B - 1 0 00 B ru s s e ls 2010 CENELEC - All rights of exploitation in an

8、y form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-1-6:2010 EICS 11.040 English versionMedical electricalequipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability(IEC 60601-1-6:2010)Appareils lectromdicaux -Pa

9、rtie 1-6: Exigences gnrales pour la scurit de base et les performances essentielles -Norme collatrale: Aptitude lutilisation (CEI 60601-1-6:2010)Medizinische elektrische Gerte -Teil 1-6: Allgemeine Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale -Ergnzungsnorm: Gebrau

10、chstauglichkeit (IEC 60601-1-6:2010)This European Standard was approved by CE NELEC on 201 0-04-01. CENELEC members are bound to comply w i t h t h e C E N / C E N E L E C I n t e r n a l R e g u l a t i o n s w h i c h s t i p u l a t e t h e c o n d i t i o n s f o r g i v i n g t h i s E u r o p

11、e a n S t a n d a r d 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 Central Secretariat or to any CENELEC member. This European Standard exists in three official versi

12、ons (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 Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of A

13、ustria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the Unite

14、d Kingdom.May 2015Foreword The textofdocument 62A/682/FDIS, future edition 3 of IEC 60601-1-6, prepared bySC 62A, Commonaspects of electrical equipment used in medical practice, ofIEC TC 62, Electrical equipment in medical practice, wassubmitted to the IEC-CENELEC parallel vote and wasapproved by CE

15、NELEC asEN 60601-1-6 on 2010-04-01.This standard supersedes EN 60601-1-6:2007.Attention is drawn to the possibilitythat some of the elements of this document maybe the subject ofpatent rights. CEN and CENELEC shall not be held responsible foridentifying anyorall such patentrights.The following dates

16、 were fixed: latestdate by which the EN has to be implemented at nationallevel bypublication of an identicalnational standardorbyendorsement (dop) 2011-01-01 latestdate by which the national standards conflictingwith the EN have to be withdrawn (dow) 2013-04-01This European Standardhas been prepared

17、 under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements ofEC Directives 93/42/EECand 90/385/EEC. SeeAnnex ZZ.Annexes ZA and ZZ have been added by CENELEC._EndorsementnoticeThe textofthe International Standard IEC 60601-1-

18、6:2010 wasapproved by CENELEC as a European Standard without anymodification.In the official version, for Bibliography, the following notes have to be added forthe standards indicated:1ISO 9241-2:1992 NOTE Harmonized as EN 29241:1993 (not modified).2ISO 9241-11:1998 NOTE Harmonized as EN ISO 9241-11

19、:1998 (not modified).3ISO 9241-20:2008 NOTE Harmonized as EN ISO 9241-20:2009 (not modified).4ISO 9241-110:2006 NOTE Harmonized as EN ISO 9241-110:2006 (not modified).5ISO 9241-171:2008 NOTE Harmonized as EN ISO 9241-171:2008 (not modified).7ISO 9241-300:2008 NOTE Harmonized as EN ISO 9241-300:2008

20、(not modified).8ISO 9241-302:2008 NOTE Harmonized as EN ISO 9241-302:2008 (not modified).9ISO 9241-303:2008 NOTE Harmonized as EN ISO 9241-303:2008 (not modified).10 ISO9241-304:2008 NOTE Harmonized as EN ISO 9241-304:2008 (not modified).11 ISO9241-305:2008 NOTE Harmonized as EN ISO 9241-305:2008 (n

21、ot modified).12 ISO9241-307:2008 NOTE Harmonized as EN ISO 9241-307:2008 (not modified).13 ISO9241-400:2007 NOTE Harmonized as EN ISO 9241-400:2007 (not modified).14 ISO9241-410:2008 NOTE Harmonized as EN ISO 9241-410:2008 (not modified).16 ISO 13407:1999 NOTE Harmonized as EN ISO 13407:1999 (not mo

22、dified).BS EN 60601-1-6:2010+A1:2015 EN 60601-1-6:2010+A1:2015 2 Foreword to amendment 1 The text of document 62A/890/FDIS, future IEC 60601-1-6:2010/A1, prepared by SC 62A “Common aspects of electrical equipment used in medical practice“ of IEC/TC 62 “Electrical equipment in medical practice“ was s

23、ubmitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-1-6:2010/A1:2015. 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) 2016-01-14 latest date by

24、which the national standards conflicting with the document have to be withdrawn (dow) 2018-12-31 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 pate

25、nt 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. For the relationship with EU Directive 90/385/EEC, see informative Annex ZZ, which is an integral part

26、of this document. For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-1-6:2010. Endorsement notice The text of the International Standard IEC 60601-1-6:2010/A1:2013 was approved by CENELEC as a European Standard without any modification. 3 BS EN 60601-1-6

27、:2010+A1:2015 EN 60601-1-6:2010+A1:2015A nnex ZA(normative)Normative references to international publicationswith their corresponding European publications Publication Year Title EN/HD YearIEC 60601-12005 Medical electrical equipment -Part1:General requirements forbasicsafety and essential performan

28、ceEN 60601-12006IEC 60601-1-82006 Medical electrical equipment -Part1-8:General requirements forbasicsafety and essential performance -Collateral Standard: General requirements,testsand guidancefor alarmsystems in medical electrical equipment and medical electricalsystemsEN 60601-1-82007IEC 62366200

29、7 Medical devices -Application of usabilityengineeringto medical devicesEN 623662008ISO14971 2007 Medical devices -Application of riskmanagement to medical devicesEN ISO 14971 2009The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its

30、application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD appl

31、ies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu + corr. March+ corr. March+A1 2012 +A1 +A1/AC 2013 2014 +A12 2014 20102010+A1 2012 +A1 +A1/AC 2013 2014 +A1 2014 A1 2015BS EN 60601-1-6:2010+A1:2015 EN 60601-1-6

32、:2010+A1:2015 4 Annex ZZ(informative)Coverage of Essential Requirements of EU Directives 5 BS EN 60601-1-6:2010+A1:2015 EN 60601-1-6:2010+A1:2015This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and within it

33、s scope the Standard covers all relevant essential requirements given in Annex 1 of EU Directive 90/385/EEC of 20 June 1990 relating to active implantable medical devices. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concer

34、ned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. CONTENTSINTRODUCTION.101 Scope, object and related standards.111.1 * Scope .111.2 Object .111.3 Related standards .111.3.1 IEC 60601-1111.3.2 Particular standards 112 No

35、rmative references .113 Terms and definitions.124 General requirements.124.1 * Conditions for application to ME EQUIPMENT .124.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT135 * Replacement of requirements given in IEC 6236613Annex A (informative) General guidance and rationale.14Annex B (infor

36、mative) Mapping between the elements o fIEC 60601-1-6:2006 and the related elements in IEC 62366:2007 .16AnnexC (informative)References to items of USABILITY provided in IEC 62366:2007 and their use in other standards24Bibliography27Index of defined terms used with this collateral standard 29TableB.

37、1 Mapping between the elements of IEC 606 01-1-6:2006and the relatedelements in IEC 62366:2007.16TableC.1 Referencesto itemsof USABILITY in IEC 62366 andtheir use in otherstandards24BS EN 60601-1-6:2010+A1:2015 60601-1-6 IEC:2010+A1:2013 6 MEDICAL ELECTRICAL EQUIPMENT Part 1-6: General requirements

38、for basic safety and essential performance Collateral standard: Usability 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 int

39、ernational co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereaf

40、ter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; 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 partic

41、ipate in this preparation. IEC collaborates closely with the International 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

42、international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all r

43、easonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply

44、 IEC Publications transparently to 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 itself does not provide any attestation of co

45、nformity. Independent certification bodies provide conformity 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 publi

46、cation. 7) No liability shall attach to IEC or its directors, 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,

47、or for costs (including legal fees) and expenses arising out of 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 corr

48、ect application of this publication. 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. 7 BS EN 60601-1-6:2010+A1:2015 60601-1-6 IEC:2010+A1:2

49、013International Standard IEC 60601-1-6 has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. This third edition constitutes a collateral standard to IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. This document cancels and replaces the second edition of IEC 6