1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 1-6: General requirements for basic safety and essential performance Collateral standard: UsabilityBS EN 60601-1-6:2010Licensed Copy: Wang Bin, I
2、SO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:05, Uncontrolled Copy, (c) BSINational forewordThis British Standard is the UK implementation of EN 60601-1-6:2010. It isidentical to IEC 60601-1-6:2010. It supersedes BS EN 60601-1-6:2007 whichwill be withdrawn on 1 April 2013.The UK participation in its p
3、reparation was entrusted by Technical CommitteeCH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/1,Common aspects of Electrical Equipment used in Medical Practice.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication do
4、es not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2010 ISBN 978 0 580 65037 6 ICS 11.040.01Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authorit
5、y of the Standards Policy and Strategy Committee on 31 May 2010.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 60601-1-6:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:05, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD EN 60601-1-6 NORME EU
6、ROPENNE EUROPISCHE NORM April 2010 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2010 CENELEC - All rights of exploitation in an
7、y form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-1-6:2010 E ICS 11.040 Supersedes EN 60601-1-6:2007English version Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6
8、:2010) Appareils lectromdicaux - Partie 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 Le
9、istungsmerkmale - Ergnzungsnorm: Gebrauchstauglichkeit (IEC 60601-1-6:2010) This European Standard was approved by CENELEC on 2010-04-01. 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 nat
10、ional 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 versions (English, French, German). A version
11、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 Austria, Belgium, Bulgaria, Croatia, Cypr
12、us, 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 United Kingdom. BS EN 60601-1-6:2010Licensed
13、Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:05, Uncontrolled Copy, (c) BSIEN 60601-1-6:2010 - 2 - Foreword The text of document 62A/682/FDIS, future edition 3 of IEC 60601-1-6, prepared by SC 62A, Common aspects of electrical equipment used in medical practice, of IEC TC 62, Electric
14、al equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-6 on 2010-04-01. This standard supersedes EN 60601-1-6:2007. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights
15、. CEN and CENELEC shall not be held responsible for identifying any or all such patent rights. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2011-01-01 latest date by which
16、the national standards conflicting with the EN have to be withdrawn (dow) 2013-04-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directives 93/42/EEC and 90/385/EE
17、C. See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-1-6:2010 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 t
18、he standards indicated: 1 ISO 9241-2:1992 NOTE Harmonized as EN 29241:1993 (not modified). 2 ISO 9241-11:1998 NOTE Harmonized as EN ISO 9241-11:1998 (not modified). 3 ISO 9241-20:2008 NOTE Harmonized as EN ISO 9241-20:2009 (not modified). 4 ISO 9241-110:2006 NOTE Harmonized as EN ISO 9241-110:2006 (
19、not modified). 5 ISO 9241-171:2008 NOTE Harmonized as EN ISO 9241-171:2008 (not modified). 7 ISO 9241-300:2008 NOTE Harmonized as EN ISO 9241-300:2008 (not modified). 8 ISO 9241-302:2008 NOTE Harmonized as EN ISO 9241-302:2008 (not modified). 9 ISO 9241-303:2008 NOTE Harmonized as EN ISO 9241-303:20
20、08 (not modified). 10 ISO 9241-304:2008 NOTE Harmonized as EN ISO 9241-304:2008 (not modified). 11 ISO 9241-305:2008 NOTE Harmonized as EN ISO 9241-305:2008 (not modified). 12 ISO 9241-307:2008 NOTE Harmonized as EN ISO 9241-307:2008 (not modified). 13 ISO 9241-400:2007 NOTE Harmonized as EN ISO 924
21、1-400:2007 (not modified). 14 ISO 9241-410:2008 NOTE Harmonized as EN ISO 9241-410:2008 (not modified). 16 ISO 13407:1999 NOTE Harmonized as EN ISO 13407:1999 (not modified). BS EN 60601-1-6:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:05, Uncontrolled Copy, (c) BSI- 3 -
22、EN 60601-1-6:2010 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated refere
23、nces, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC 60601-1 2005 Medical electrical equipment -
24、Part 1: General requirements for basic safety and essential performance EN 60601-1 2006 IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in med
25、ical electrical equipment and medical electrical systems EN 60601-1-8 2007 IEC 62366 2007 Medical devices - Application of usability engineering to medical devices EN 62366 2008 ISO 14971 2007 Medical devices - Application of risk management to medical devices EN ISO 14971 2009 BS EN 60601-1-6:2010L
26、icensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:05, Uncontrolled Copy, (c) BSIEN 60601-1-6:2010 - 4 - Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission an
27、d the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC as well as Annex I of the EC Directive 90/385/EEC. Compliance with this standard provides one means of conformity with the specified es
28、sential requirements of the Directive(s) concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. BS EN 60601-1-6:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:05, Uncontrolled Copy, (c) BSI
29、 2 60601-1-6 IEC:2010 CONTENTS INTRODUCTION.6 1 Scope, object and related standards.7 1.1 * Scope .7 1.2 Object .7 1.3 Related standards .7 1.3.1 IEC 60601-1 7 1.3.2 Particular standards 7 2 Normative references .7 3 Terms and definitions .8 4 General requirements.8 4.1 * Conditions for application
30、to ME EQUIPMENT .8 4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT8 5 * Replacement of requirements given in IEC 62366 9 Annex A (informative) General guidance and rationale.10 Annex B (informative) Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007 .1
31、2 Annex C (informative) References to items of USABILITY provided in IEC 62366:2007 and their use in other standards19 Bibliography22 Index of defined terms used with this collateral standard 24 Table B.1 Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007 .
32、12 Table C.1 References to items of USABILITY in IEC 62366 and their use in other standards19 BS EN 60601-1-6:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:05, Uncontrolled Copy, (c) BSI 6 60601-1-6 IEC:2010 INTRODUCTION Medical practice is increasingly using MEDICAL ELECT
33、RICAL EQUIPMENT for observation and treatment of PATIENTS. USE ERRORS caused by inadequate MEDICAL ELECTRICAL EQUIPMENT USABILITY have become an increasing cause for concern. Much of ME EQUIPMENT developed without applying a USABILITY ENGINEERING PROCESS are non-intuitive, difficult to learn and to
34、use. As healthcare evolves, less skilled OPERATORS including PATIENTS themselves are now using MEDICAL ELECTRICAL EQUIPMENT while the MEDICAL ELECTRICAL EQUIPMENT itself is becoming more complicated. In simpler times, the OPERATOR of the MEDICAL ELECTRICAL EQUIPMENT might be able to cope with an amb
35、iguous, difficult-to-use OPERATOR-EQUIPMENT INTERFACE. The design of usable MEDICAL ELECTRICAL EQUIPMENT is a challenging endeavour. The design of the OPERATOR-EQUIPMENT INTERFACE to achieve adequate (safe) USABILITY requires a very different skill set than that of the technical implementation of th
36、at interface. The USABILITY ENGINEERING PROCESS is intended to achieve reasonable USABILITY, which in turn is intended to minimise USE ERRORS and to minimise use-associated RISKS. Some, but not all, forms of incorrect use are amenable to be controlled by the MANUFACTURER. The relationship of the USA
37、BILITY ENGINEERING PROCESS to the RISK MANAGEMENT PROCESS is described in Figure A.1 of IEC 62366:2007. The first and second editions of this collateral standard described a USABILITY ENGINEERING PROCESS that was tailored to the needs of MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT. They provided g
38、uidance on how to implement and execute the PROCESS to improve the safety of MEDICAL ELECTRICAL EQUIPMENT. Subclause 1.3 of IEC 60601-1:2005 states that, “Applicable collateral standards become normative at the date of their publication and shall apply together with this standard.” Consequently, the
39、 second edition of this collateral standard was developed specifically to align with IEC 60601-1:2005 and published in 2006. All other relevant collateral standards within the jurisdiction of IEC Subcommittee 62A also were updated and republished between 2006 and 2007 except for IEC 60601-1-1 and IE
40、C 60601-1-4. These collateral standards were not revised because their requirements were integrated into IEC 60601-1:2005. After the second edition of this collateral standard was published, IEC Subcommittee 62A, in partnership with ISO Technical Committee 210, developed and published a general usab
41、ility engineering standard applicable to all MEDICAL DEVICESIEC 62366:2007. IEC 62366 is based on IEC 60601-1-6, but was refined using the experience gained with applying the first edition of IEC 60601-1-6. Although the processes described in IEC 60601-1-6:2006 and IEC 62366:2007 are very similar, t
42、hey are not identical. At its Auckland meeting in 2008, IEC Technical Committee 62 approved a project to revise IEC 60601-1-6 so that it would reduce or eliminate duplication with IEC 62366 and also create a bridge between IEC 60601-1 and IEC 62366. This third edition of IEC 60601-1-6 creates that b
43、ridge and will enable a MANUFACTURER to conform to the requirements in IEC 60601-1:2005 that make normative reference to IEC 60601-1-6 by employing a USABILITY ENGINEERING PROCESS complying with IEC 62366:2007. At a point in the future, that bridge can be eliminated by revising or amending IEC 60601
44、-1 to include a direct reference to IEC 62366 and, as necessary, adding any additional requirements that are specific to medical electrical equipment, such as those contained in Clauses 4 and 5 of this collateral standard, to IEC 60601-1 or as a normative annex to IEC 62366. This collateral standard
45、 is intended to be useful not only for MANUFACTURER(S) of MEDICAL ELECTRICAL EQUIPMENT, but also for technical committees responsible for the preparation of particular MEDICAL ELECTRICAL EQUIPMENT standards. It should be noted that clinical investigations conducted according to ISO 14155-1 and usabi
46、lity testing for verification or validation according to this standard are two fundamentally different activities and should not be confused. BS EN 60601-1-6:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:05, Uncontrolled Copy, (c) BSI60601-1-6 IEC:2010 7 MEDICAL ELECTRICAL
47、 EQUIPMENT Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability 1 Scope, object and related standards 1.1 * Scope This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it r
48、elates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identi
49、fy but does not assess or mitigate RISKS associated with ABNORMAL USE. If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.
