1、BSI Standards PublicationMedical devicesPart 1: Application of usability engineering to medical devicesBS EN 62366-1:2015BS EN 62366-1:2015Incorporating corrigendum December 2015BS EN 62366-1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 62366-1:2015, inc
2、orporating corrigendum December 2015. It is identical to IEC 62366-1:2015. Together with PD IEC/TR 62366-2 (not yet published) it supersedes BS EN 62366:2008+A1:2015, which will be withdrawn on 31 March 2018.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electric
3、al 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.This publication does not purport to include all the necessary provisions of
4、 a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 91868 1ICS 11.040.01Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under
5、 the authority of the Standards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affected31 January 2016 Implementation of CENELEC corrigendum December 2015: Supersession information updated on EN pagesEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NO
6、RMEN 62366-1 April 2015 ICS 11.040 English Version Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015) Dispositifs mdicaux - Partie 1: Application de lingnieriede laptitude lutilisation aux dispositifs mdicaux (IEC 62366-1:2015) Medizinprodukte - Anwe
7、ndung der Gebrauchstauglichkeitauf Medizinprodukte (IEC 62366-1:2015) This European Standard was approved by CENELEC on 2015-03-31. 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
8、standard 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, C
10、roatia, 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, T
11、urkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form a
12、nd by any means reserved worldwide for CENELEC Members. Ref. No. EN 62366-1:2015 E Incorporating corrigendum December 2015Supersedes EN 62366:2008EN 62366-1:2015 - 2 - Foreword The text of document 62A/977/FDIS, future edition 1 of IEC 62366-1, prepared by SC 62A, “Common aspects of electrical equip
13、ment used in medical practice“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62366-1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication o
14、f an identical national standard or by endorsement (dop) 2015-12-31 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-03-31 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CE
15、NELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. Endorsement notice The text of the International Standard IEC 62366-1:2015 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following n
16、otes have to be added for the standards indicated: IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006. IEC 60601-1:2005/A1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013. IEC 60601-1-6:2010 NOTE Harmonized as EN 60601-1-6:2010. IEC 60601-1-6:2010/A1:2013 NOTE Harmonized as EN 60601-1-6:2010/A1:201
17、3. IEC 60601-1-8:2006 NOTE Harmonized as EN 60601-1-8:2007. IEC 60601-1-8:2006/A1:2012 NOTE Harmonized as EN 60601-1-8:2007/A1:2013. IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11. ISO 7010:2011 NOTE Harmonized as EN ISO 7010:2012. ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005. ISO 9001:2008 NO
18、TE Harmonized as EN ISO 9001:2008. ISO 9241-11:1998 NOTE Harmonized as EN ISO 9241-11:1998. ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012. BS EN 62366-1:2015EN 62366-1:2015 - 2 - Foreword The text of document 62A/977/FDIS, future edition 1 of IEC 62366-1, prepared by SC 62A, “Common aspects of
19、 electrical equipment used in medical practice“, of IEC/TC 62 “Electrical equipment in medicalpractice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62366-1:2015. The following dates are fixed: latest date by which the document has to be implemented at nati nal level
20、by publication of an identical national standard or by endorsement (dop) 2015-12-31 latest date by which the national standards conflicting with the document have to be ithdrawn (dow) 2018-03-31 Attention is drawn to the possibility that some of the elements of this document may be the subject of pa
21、t nt rights. CENELEC and/or CEN shall not be held responsible for identifying an or all such patent rights. Endorsement notice The text of the International Standard IEC 62366-1:2015 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, t
22、he following notes have to be added for the standards indicated: IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006. IEC 60601-1:2005/A1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013. IEC 60601-1-6:2010 NOTE Harmonized as EN 60601-1-6:2010. IEC 60601-1-6:2010/A1:2013 NOTE Harmonized as EN 60601-1
23、6:2010/A1:2013. IEC 60601-1-8:2006 NOTE Harmonized as EN 60601-1-8:2007. IEC 60601-1-8:2006/A1:2012 NOTE Harmonized as EN 60601-1-8:2007/A1:2013. IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11. ISO 7010:2011 NOTE Harmonized as EN ISO 7010:2012. ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005. IS
24、O 9001:2008 NOTE Harmonized as EN ISO 9001:2008. ISO 9241-11:1998 NOTE Harmonized as EN ISO 9241-11:1998. ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012. BS EN 62366-1:2015This document supersedes EN 62366:2008.EN 62366-1:2015 - 2 - Foreword The text of document 62A/977/FDIS, future edition 1 o
25、f IEC 62366-1, prepared by SC 62A, “Common aspects of electrical equipment used in medical practice“, of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62366-1:2015. The following dates are fixed: latest date by which
26、 the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2015-12-31 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-03-31 Attention is drawn to the possibility that some of
27、 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. Endorsement notice The text of the International Standard IEC 62366-1:2015 was approved by CENELEC as a European Standard without any mo
28、dification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006. IEC 60601-1:2005/A1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013. IEC 60601-1-6:2010 NOTE Harmonized as EN 60601-1-6:2010.
29、IEC 60601-1-6:2010/A1:2013 NOTE Harmonized as EN 60601-1-6:2010/A1:2013. IEC 60601-1-8:2006 NOTE Harmonized as EN 60601-1-8:2007. IEC 60601-1-8:2006/A1:2012 NOTE Harmonized as EN 60601-1-8:2007/A1:2013. IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11. ISO 7010:2011 NOTE Harmonized as EN ISO 7010:201
30、2. ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005. ISO 9001:2008 NOTE Harmonized as EN ISO 9001:2008. ISO 9241-11:1998 NOTE Harmonized as EN ISO 9241-11:1998. ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012. BS EN 62366-1:2015- 3 - EN 62366-1:2015 Annex ZA (normative) Normative references to
31、international publications 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 edit
32、ion 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 applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex i
33、s available here: www.cenelec.eu. Publication Year Title EN/HD Year ISO 14971 2007 Medical devices - Application of risk management to medical devices EN ISO 14971 2012 BS EN 62366-1:2015EN 62366-1:2015 - 2 - Foreword The text of document 62A/977/FDIS, future edition 1 of IEC 62366-1, prepared by SC
34、 62A, “Common aspects of electrical equipment used in medical practice“, of IEC/TC 62 “Electrical equipment in medicalpractice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62366-1:2015. The following dates are fixed: latest date by which the document has to be implem
35、ented at nati nal level by publication of an identical national standard or by endorsement (dop) 2015-12-31 latest date by which the national standards conflicting with the document have to be ithdrawn (dow) 2018-03-31 Attention is drawn to the possibility that some of the elements of this document
36、may be the subject of pat nt rights. CENELEC and/or CEN shall not be held responsible for identifying an or all such patent rights. Endorsement notice The text of the International Standard IEC 62366-1:2015 was approved by CENELEC as a European Standard without any modification. In the official vers
37、ion, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006. IEC 60601-1:2005/A1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013. IEC 60601-1-6:2010 NOTE Harmonized as EN 60601-1-6:2010. IEC 60601-1-6:2010/A1:2013 NOTE
38、Harmonized as EN 60601-1-6:2010/A1:2013. IEC 60601-1-8:2006 NOTE Harmonized as EN 60601-1-8:2007. IEC 60601-1-8:2006/A1:2012 NOTE Harmonized as EN 60601-1-8:2007/A1:2013. IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11. ISO 7010:2011 NOTE Harmonized as EN ISO 7010:2012. ISO 9000:2005 NOTE Harmonized
39、 as EN ISO 9000:2005. ISO 9001:2008 NOTE Harmonized as EN ISO 9001:2008. ISO 9241-11:1998 NOTE Harmonized as EN ISO 9241-11:1998. ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012. BS EN 62366-1:2015 2 IEC 62366-1:2015 IEC 2015 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 * Scope . 7 2 Normative refer
40、ences 7 3 Terms and definitions 7 4 Principles 12 4.1 General requirements . 12 4.1.1 * USABILITY ENGINEERING PROCESS 12 4.1.2 * RISK CONTROL as it relates to USER INTERFACE design . 13 4.1.3 Information for SAFETY as it relates to USABILITY . 13 4.2 * USABILITY ENGINEERING FILE . 14 4.3 Tailoring o
41、f the USABILITY ENGINEERING effort . 14 5 * USABILITY ENGINEERING PROCESS 14 5.1 * Prepare USE SPECIFICATION . 14 5.2 * Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS . 15 5.3 * Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS 15 5.4 * Identify and d
42、escribe HAZARD-RELATED USE SCENARIOS 15 5.5 * Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION . 16 5.6 * Establish USER INTERFACE SPECIFICATION . 16 5.7 * Establish USER INTERFACE EVALUATION plan . 16 5.7.1 General . 16 5.7.2 * FORMATIVE EVALUATION planning 17 5.7.3 * SUMMATIVE EVAL
43、UATION planning 17 5.8 * Perform USER INTERFACE design, implementation and FORMATIVE EVALUATION . 18 5.9 * Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE 19 5.10 USER INTERFACE OF UNKNOWN PROVENANCE 19 Annex A (informative) General guidance and rationale . 20 A.1 General guidanc
44、e 20 A.2 Rationale for requirements in particular clauses and subclauses . 20 ANNEX B (informative) Examples of possible HAZARDOUS SITUATIONS related to USABILITY . 38 Annex C (normative) Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) . 41 C.1 General . 41 C.2 USABILITY ENGINEERING PROC
45、ESS for USER INTERFACE OF UNKNOWN PROVENANCE 41 C.2.1 * USE SPECIFICATION . 41 C.2.2 * Review of POST-PRODUCTION information . 42 C.2.3 HAZARDS and HAZARDOUS SITUATIONS related to USABILITY. 42 C.2.4 RISK CONTROL 42 C.2.5 RESIDUAL RISK evaluation . 42 Annex D (informative) Types of MEDICAL DEVICE us
46、e, with examples . 43 Annex E (informative) Reference to the essential principles . 45 Bibliography 46 Index of defined terms 49 BS EN 62366-1:2015 2 IEC 62366-1:2015 IEC 2015 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 * Scope . 7 2 Normative references 7 3 Terms and definitions 7 4 Principles 12 4.1
47、General requirements . 12 4.1.1 * USABILITY ENGINEERING PROCESS 12 4.1.2 * RISK CONTROL as it relates to USER INTERFACE design . 13 4.1.3 Information for SAFETY as it relates to USABILITY . 13 4.2 * USABILITY ENGINEERING FILE . 14 4.3 Tailoring of the USABILITY ENGINEERING effort . 14 5 * USABILITY
48、ENGINEERING PROCESS 14 5.1 * Prepare USE SPECIFICATION . 14 5.2 * Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS . 15 5.3 * Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS 15 5.4 * Identify and describe HAZARD-RELATED USE SCENARIOS 15 5.5 * Select t
49、he HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION . 16 5.6 * Establish USER INTERFACE SPECIFICATION . 16 5.7 * Establish USER INTERFACE EVALUATION plan . 16 5.7.1 General . 16 5.7.2 * FORMATIVE EVALUATION planning 17 5.7.3 * SUMMATIVE EVALUATION planning 17 5.8 * Perform USER INTERFACE design, implementation and FORMATIVE EVALUATION . 18 5.9 * Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE 19 5.10 USER INTERFACE OF UNKNOWN PROVENANCE 19 Annex A (informative) General guidance and rationale . 20 A.1 General guidance
