IEC 62366 Edition 1.1-2014 Medical devices - Application of usability engineering to medical devices《医疗器械.医疗器械可用性工程的应用》.pdf

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1、 IEC 62366 Edition 1.1 2014-01 CONSOLIDATED VERSION VERSION CONSOLIDE Medical devices Application of usability engineering to medical devices Dispositifs mdicaux Application de lingnierie de laptitude lutilisation aux dispositifs mdicaux IEC62366:2007-10+AMD1:2014-01CSV(EN-FR)colourinsideTHIS PUBLIC

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19、ez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 62366 Edition 1.1 2014-01 CONSOLIDATED VERSION VERSION CONSOLIDE Medical devices Application of usability engineering to medical devices Dispositifs mdicaux Application de lingnierie de

20、 laptitude lutilisation aux dispositifs mdicaux INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040 ISBN 978-2-8322-1371-1 Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez

21、obtenu cette publication via un distributeur agr. colourinsideIEC 62366 Edition 1.1 2014-01 REDLINE VERSION VERSION REDLINE Medical devices Application of usability engineering to medical devices Dispositifs mdicaux Application de lingnierie de laptitude lutilisation aux dispositifs mdicaux IEC62366

22、:2007-10+AMD1:2014-01CSV(EN-FR)colourinside 2 62366 IEC:2007+A1:2014 CONTENTS FOREWORD . 4 INTRODUCTION . 6 INTRODUCTION TO THE AMENDMENT 7 1 * Scope 8 2 Normative references . 8 3 Terms and definitions . 8 4 * Principles . 12 4.1 General requirements 12 4.1.1 * USABILITY ENGINEERING PROCESS 12 4.1.

23、2 RESIDUAL RISK 12 4.1.3 Information for SAFETY . 13 4.2 * USABILITY ENGINEERING FILE . 13 4.3 Scaling of the USABILITY ENGINEERING effort 13 5 * USABILITY ENGINEERING PROCESS . 14 5.1 * Application specification 14 5.2 * Frequently used functions . 14 5.3 Identification of HAZARDS and HAZARDOUS SIT

24、UATIONS related to USABILITY 14 5.3.1 Identification of characteristics related to SAFETY . 14 5.3.2 * Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS . 15 5.4 PRIMARY OPERATING FUNCTIONS 15 5.5 * USABILITY SPECIFICATION 16 5.6 USABILITY VALIDATION plan 16 5.7 * USER INTERFAC

25、E design and implementation 17 5.8 * USABILITY VERIFICATION 17 5.9 * USABILITY VALIDATION . 18 5.10 * USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) . 18 6 * ACCOMPANYING DOCUMENT 18 7 * Training and materials for training 19 Annex A (informative) General guidance and rationale . 20 Annex B (informativ

26、e) Categories of USER action 32 Annex C (informative) Examples of USE ERRORS, ABNORMAL USE and possible causes . 34 Annex D (informative) Guidance on the USABILITY ENGINEERING PROCESS 37 ANNEX E (informative) Questions that can be used to identify MEDICAL DEVICE characteristics associated with USABI

27、LITY that could impact on SAFETY . 61 ANNEX F (informative) Examples of possible USABILITY related HAZARDOUS SITUATIONS 65 Annex G (informative) USABILITY goals: Illustrative example for a home parenteral infusion pump . 68 ANNEX H (informative) Sample USABILITY SPECIFICATION and its inputs 78 Annex

28、 I (informative) Recommended reading list . 88 Annex J (informative) Reference to the essential principles . 96 Annex K (normative) Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) . 97 62366 IEC:2007+A1:2014 3 Bibliography 99 Index of defined terms 101 Figure A.1 A comparison of the RISK

29、 MANAGEMENT PROCESS (ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366) 25 Figure B.1 Categories of foreseeable USER action 33 Figure D.1 A USER INTERFACE design cycle . 40 Figure D.2 Bubble diagram of the conceptual model of a physiological monitor 53 Figure F.1 Pictorial representat

30、ion of the relationship of HAZARD, sequence of events, HAZARDOUS SITUATION and HARM 66 Table D.1 Sample of design flaws and associated USE ERRORS 38 Table D.2 Mapping of Figure D.1 to the subclauses of this International Standard . 40 Table D.3 Examples of USER INTERFACE requirements 43 Table D.4 Ty

31、pical deliverables . 48 Table D.5 Examples of objective USABILITY goals . 51 Table D.6 Examples of subjective USABILITY goals 51 Table D.7 Examples of USER INTERFACE modelling techniques 54 Table D.8 Characteristics of a typical USABILITY testing effort . 54 Table F.1 Glossary of relevant RISK MANAG

32、EMENT terms . 65 Table F.2 Examples of HARM due to USABILITY related HAZARDS . 66 Table G.1 Power on/off 71 Table G.2 Program pump . 71 Table G.3 Start/stop infusion 72 Table G.4 Monitor infusion status . 73 Table G.5 Install and change set 73 Table G.6 Priming 74 Table G.7 Respond to and inactivate

33、 ALARM SIGNALSa74 Table G.8 Lockouts 75 Table G.9 Power management . 75 Table G.10 Preventative and routine maintenance . 76 Table G.11 Basic operation 77 Table G.12 Advanced functions . 77 Table J.1 Correspondence between this document and the essential principles . 96 4 62366 IEC:2007+A1:2014 INTE

34、RNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL DEVICES APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees

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45、s 62A/574/FDIS and 62A/579/RVD and its amendment 1 (2014-01) documents 62A/889/FDIS and 62A/897/RVD. The technical content is identical to the base edition and its amendment. In this Redline version, a vertical line in the margin shows where the technical content is modified by amendment 1. Addition

46、s and deletions are displayed in red, with deletions being struck through. A separate Final version with all changes accepted is available in this publication. This publication has been prepared for user convenience. 62366 IEC:2007+A1:2014 5 International Standard IEC 62366 has been prepared by a jo

47、int working group of subcommittee 62A: Common aspects of electrical medical equipment used in medical practice, of IEC technical committee 62: Electrical medical equipment in medical practice and technical committee ISO/TC 210: Quality management and corresponding general aspects for medical devices

48、. It is published as double logo standard. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this International Standard, the following print types are used: Requirements and definitions: roman type. Means to assess compliance: italic type. Informative material

49、appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type TERMS DEFINED IN CLAUSE 3 OR AS NOTED: SMALL CAPITALS. The requirements are followed by means to assess compliance. Clause and subclauses for which a rationale is provided in informative Annex A are marked with an asterisk (*). The commi