1、BRITISH STANDARDBS EN 62366:2008Medical devices Application of usability engineering to medical devicesICS 11.040.01g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g
2、43g55g3g47g36g58BS EN +A1:2015BS EN 62366:2008+A1:2015ISBN 978 0 580 80327 7Amendments/corrigenda issued since publicationDate Comments30 June 2015 Implementation of IEC amendment 1:2014 with CENELEC endorsement A1:2015This British Standard was published under the authority of the Standards Policy a
3、nd Strategy Committee on 30 April 2008 The British Standards Institution 2015. Published by BSI Standards Limited 2015National forewordThis British Standard is the UK implementation of EN 62366:2008+A1:2015. It is identical to IEC 62366:2007, incorporating amendment 1:2014. It supersedes BS EN 62366
4、:2008, which will be withdrawn on 14 April 2018.The start and finish of text introduced or altered by amendment is indicated in the text by tags.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 altered by IEC amendment 1 is indicated by .The UK participat
5、ion in its preparation was entrusted by Technical Committee CH/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 subcommittee can be obtained on request to its secretary.T
6、his publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARD EN 62366 NORME EUROPENNE EUROPISCHE NORM January 2008 CENELEC E
7、uropean Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide
8、 for CENELEC members. Ref. No. EN 62366:2008 E ICS 11.040 English version Medical devices - Application of usability engineering to medical devices (IEC 62366:2007) Dispositifs mdicaux - Application de lingnierie de laptitude lutilisation aux dispositifs mdicaux (CEI 62366:2007) Medizinprodukte - An
9、wendung der Gebrauchstauglichkeit auf Medizinprodukte (IEC 62366:2007) This European Standard was approved by CENELEC on 2007-12-01. 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 national
10、 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 in an
11、y 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, Cyprus, the Czech
12、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. EN 62366:2008+A1May 2015Foreword The text o
13、f document 62A/574/FDIS, future edition 1 of IEC 62366, prepared by a joint working group of subcommittee 62A: Common aspects of electrical medical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice and ISO/TC 210, Quality management and corresponding general
14、aspects for medical devices, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 62366 on 2007-12-01. 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 (d
15、op) 2008-09-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2010-12-01 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 E
16、C Directives MDD (93/42/EEC) and IVD (98/79/EC). See Annex ZZ. In this standard, the following print types are used: Requirements and definitions: roman type. Means to assess compliance: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller
17、 type. Normative text of tables is also in a smaller type TERMS DEFINED IN CLAUSE 3 OR AS NOTED: SMALL CAPITALS. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 62366:2007 was approved by CENELEC as a European Standard without any modific
18、ation. _ BS EN 62366:2008 2 - 2 -BS EN 62366:2008+A1:2015EN 62366:2008+A1:2015- 3 -BS EN 62366:2008+A1:2015EN 62366:2008+A1:2015EN 62366:2008/A1:2015 2 Foreword The text of document 62A/889/FDIS, future IEC 62366:2007/A1, prepared by SC 62A “Common aspects of electrical equipment used in medical pra
19、ctice“ of IEC/TC 62 “Electrical equipment in medical practice“ and ISO/TC 210 “Quality management and corresponding general aspects for medical devices“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62366:2008/A1:2015. The following dates are fixed: latest date by whic
20、h 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 which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 Attention is drawn to the possibility that some o
21、f 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 patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, an
22、d supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 62366:2008. This standard covers the Principle Elements of the Safety Objectives for Electrical Equipment Designed for Use within Certain Voltage Limits (LVD
23、- 2006/95/EC). Endorsement notice The text of the International Standard IEC 62366:2007/A1:2014 was approved by CENELEC as a European Standard without any modification. Foreword to amendment 1CONTENTS INTRODUCTION.5 1 * Scope 6 2 Normative references .6 3 Terms and definitions .6 4 * Principles.10 4
24、.1 General requirements10 4.1.1 * USABILITY ENGINEERING PROCESS 10 4.1.2 RESIDUAL RISK 10 4.1.3 Information for SAFETY .11 4.2 * USABILITY ENGINEERING FILE .11 4.3 Scaling of the USABILITY ENGINEERING effort11 5 * USABILITY ENGINEERING PROCESS.11 5.1 * Application specification11 5.2 * Frequently us
25、ed functions .12 5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY 12 5.3.1 Identification of characteristics related to SAFETY .12 5.3.2 * Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS.13 5.4 PRIMARY OPERATING FUNCTIONS 13 5.5 * USABILITY SPECIFIC
26、ATION 14 5.6 USABILITY VALIDATION plan14 5.7 * USER INTERFACE design and implementation 15 5.8 * USABILITY VERIFICATION15 5.9 * USABILITY VALIDATION.16 6 * ACCOMPANYING DOCUMENT 16 7 * Training and materials for training17 Annex A (informative) General guidance and rationale.18 Annex B (informative)
27、 Categories of USER action30 Annex C (informative) Examples of USE ERRORS, ABNORMAL USE and possible causes.32 Annex D (informative) Guidance on the USABILITY ENGINEERING PROCESS35 ANNEX E (informative) Questions that can be used to identify MEDICAL DEVICE characteristics associated with USABILITY t
28、hat could impact on SAFETY.59 ANNEX F (informative) Examples of possible USABILITY related HAZARDOUS SITUATIONS63 Annex G (informative) USABILITY goals: Illustrative example for a home parenteral infusion pump .66 ANNEX H (informative) Sample USABILITY SPECIFICATION and its inputs 76 Annex I (inform
29、ative) Recommended reading list .86 Annex J (informative) Reference to the essential principles .94 BS EN 62366:2008 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications .99 ANNEX ZZ (informative) Coverage of Essential Requirements
30、of EC Directives .100 CONTENTS INTRODUCTION.5 1 * Scope 6 2 Normative references .6 3 Terms and definitions . 4 * Principl s.10 4.1 General requirements10 4.1.1 * USABILITY ENGINEERING PROCESS4.1.2 RESIDUAL RISK 10 4.1.3 Information for SAFETY .11 4.2 * USABILITY ENGINEERING FILE .11 4.3 Scaling of
31、the USABILITY ENGINEERING effort11 5 * USABILITY ENGINEERING PROCESS.11 5.1 * Application specification5.2 * Frequently used functions 25.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY 12 5.3.1 Identification of characteristics related to SAFETY .12 5.3.2 * Identification
32、of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS.13 5.4 PRIMARY OPERATING FUNCTIONS 13 5.5 * USABILITY SPECIFICATION 14 5.6 USABILITY VALIDATION plan14 5.7 * SER INTERFACE design and implementation 15 5.8 * USABILITY VERIFICATION15 5.9 * SABILITY VALIDATION.16 6 * ACCOMPANYING DOCUMENT 16 7
33、* Training and materials for training 7Annex A (informative) General guidance and rationale. 8 Annex B (informative) Categories of USER action30 x C (infor tiv ) Examples of USE ERRORS, ABNORMAL USE and possible causes.32 Annex D (infor ative) Guidance on the USABILITY ENGINEERING PROCESS 5 NNEX E (
34、infor ative) Questions that can be used to identify MEDICAL DEVICE characteristics associated with USABILITY that could impact on SAFETY.59 ANNEX F (informative) Examples of possible USABILITY related HAZARDOUS SITUATIONS63 Annex G (informative) USABILITY goals: Illustrative example for a home paren
35、teral infusion pump .66 ANNEX H (informative) Sample USABILITY SPECIFICATION and its inputs 76 Annex I (informative) Recommended reading list .8 nnex J (infor ative) Reference to the essential principles .94 BS EN 62366:2008 3 nnex ZA (normative) Normative references to international publications wi
36、th their corresponding European publications .99 ANNEX ZZ (informative) Coverage of Essential Requirements of EC Directives .100 CONTENTS INTRODUCTION.5 1 * Scope 2 Nor ative reference3 Te s and definition4 * Principles4.1 General requirements1 * USABILITY ENGINEERING PROCESS2 RESIDUAL RISK .3 Infor
37、mation for SAFETY2 * USABILITY ENGINEERING FILE .3 Scaling of the USABILITY ENGINEERING effort5 * USABILITY ENGINEERING PROCESS. 1 * Application specification.2 * Frequently used functions .3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY1 Identification of characteristics r
38、 lated to SAFETY . 2 * Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS.4 PRIMARY OPERATING FUNCTIONS5 * USABILITY SPECIFICATION6 USABILITY VALIDATION plan7 SER INTERFACE design and implementation 8 TY VERIFICATION9 * ITY VALIDATION6 * ACCOMPANYING DOCUMENT 7 * Training and ma
39、terials for training 7nnex A (i ative) General guidance and rationale.18 nnex B at ve) Categories of USER action 0nnex C f r t ve) Examples of USE ERRORS, ABNORMAL USE and possible causes. 2Annex D tive Guidance on the USABILITY ENGINEERING PROCESS 5ANNEX E nfor ative) Questions that can be used to
40、identify MEDICAL DEVICE characteristics associated with USABILITY that could impact on SAFETY.59 NNEX F i or ative) Examples of possible USABILITY related HAZARDOUS SITUATIONS 63nnex G i or ative) USABILITY goals: Illustrative example for a home parenteral infusion pump .6 NNEX H (informative) Sampl
41、e USABILITY SPECIFICATION and its inputs 7I (informative) ecommended reading list . 8J (infor ative) eference to the essent al principles .94BS EN 62366:2008 3 nnex ZA (nor ative) Normative references to international publications with their corresponding European publications .99 ANNEX ZZ (informat
42、ive) Coverage of Essential Requirements of EC Directives 100BS EN 62366:2008+A1:201562366 IEC:2007+A1:2014 - 4 -5.10 * User interface of unknown provenance (uoup) . Annex K (normative) Evaluation of a user interface of unknown provenance (uoup) 6777111111111212121212131313141415151616171717181931333
43、660646777879596102103Figure A.1 A comparison of the RISK MANAGEMENT PROCESS (ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366) 23 Figure B.1 Categories of foreseeable USER action31 Figure D.1 A USER INTERFACE design cycle .38 Figure D.2 Bubble diagram of the conceptual model of a phy
44、siological monitor51 Figure F.1 Pictorial representation of the relationship of HAZARD, sequence of events, HAZARDOUS SITUATION and HARM 64 Table D.1 Sample of design flaws and associated USE ERRORS 36 Table D.2 Mapping of Figure D.1 to the subclauses of this International Standard .38 Table D.3 Exa
45、mples of USER INTERFACE requirements 41 Table D.4 Typical deliverables .46 Table D.5 Examples of objective USABILITY goals .49 Table D.6 Examples of subjective USABILITY goals49 Table D.7 Examples of USER INTERFACE modelling techniques 52 Table D.8 Characteristics of a typical USABILITY testing effo
46、rt .52 Table F.1 Glossary of relevant RISK MANAGEMENT terms .63 Table F.2 Examples of HARM due to USABILITY related HAZARDS.64 Table G.1 Power on/off 69 Table G.2 Program pump.69 Table G.3 Start/stop infusion70 Table G.4 Monitor infusion status.71 Table G.5 Install and change set71 Table G.6 Priming
47、72 Table G.7 Respond to and inactivate ALARM SIGNALSa72 Table G.8 Lockouts73 Table G.9 Power management.73 Table G.10 Preventative and routine maintenance .74 Table G.11 Basic operation75 Table G.12 Advanced functions .75 Table J.1 Correspondence between this document and the essential principles .9
48、4 BS EN 62366:2008 4 Bibliography96 Index of defined terms 97 BS EN 62366:2008+A1:201562366 IEC:2007+A1:2014- 5 -9824323952653739424750505353646570707172727373747475767695100INTRODUCTION Medical practice is increasingly using MEDICAL DEVICES for observation and treatment of PATIENTS. USE ERRORS caus
49、ed by inadequate MEDICAL DEVICE USABILITY have become an increasing cause for concern. Many of the MEDICAL DEVICES developed without applying a USABILITY ENGINEERING PROCESS are non-intuitive, difficult to learn and to use. As healthcare evolves, less skilled USERS including PATIENTS themselves are now using MEDICAL DEVICES and MEDICAL DEVICES are becoming more complicated. In simpler times, the USER of a MEDICAL DEVICE might be able to cope with an ambiguous,
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