1、 IEC 62366Edition 1.0 2007-10INTERNATIONAL STANDARD NORME INTERNATIONALEMedical devices Application of usability engineering to medical devices Dispositifs mdicaux Application de lingnierie de laptitude lutilisation aux dispositifs mdicaux IEC62366:2007THIS PUBLICATION IS COPYRIGHT PROTECTED Copyrig
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16、1 22 919 02 11 Fax: +41 22 919 03 00 IEC 62366Edition 1.0 2007-10INTERNATIONAL STANDARD NORME INTERNATIONALEMedical devices Application of usability engineering to medical devices Dispositifs mdicaux Application de lingnierie de laptitude lutilisation aux dispositifs mdicaux INTERNATIONAL ELECTROTEC
17、HNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XDICS 11.040 PRICE CODECODE PRIXISBN 2-8318-9313-5 2 62366 IEC:2007 CONTENTS FOREWORD.4 INTRODUCTION.6 1 * Scope 7 2 Normative references .7 3 Terms and definitions .7 4 * Principles.11 4.1 General requirements11 4.1.1 * USABILITY ENGINEER
18、ING PROCESS 11 4.1.2 RESIDUAL RISK 11 4.1.3 Information for SAFETY .12 4.2 * USABILITY ENGINEERING FILE .12 4.3 Scaling of the USABILITY ENGINEERING effort12 5 * USABILITY ENGINEERING PROCESS.12 5.1 * Application specification12 5.2 * Frequently used functions .13 5.3 Identification of HAZARDS and H
19、AZARDOUS SITUATIONS related to USABILITY 13 5.3.1 Identification of characteristics related to SAFETY .13 5.3.2 * Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS.14 5.4 PRIMARY OPERATING FUNCTIONS 14 5.5 * USABILITY SPECIFICATION 15 5.6 USABILITY VALIDATION plan15 5.7 * USER
20、INTERFACE design and implementation 16 5.8 * USABILITY VERIFICATION16 5.9 * USABILITY VALIDATION.17 6 * ACCOMPANYING DOCUMENT 17 7 * Training and materials for training18 Annex A (informative) General guidance and rationale.19 Annex B (informative) Categories of USER action31 Annex C (informative) E
21、xamples of USE ERRORS, ABNORMAL USE and possible causes.33 Annex D (informative) Guidance on the USABILITY ENGINEERING PROCESS36 ANNEX E (informative) Questions that can be used to identify MEDICAL DEVICE characteristics associated with USABILITY that could impact on SAFETY.60 ANNEX F (informative)
22、Examples of possible USABILITY related HAZARDOUS SITUATIONS64 Annex G (informative) USABILITY goals: Illustrative example for a home parenteral infusion pump .67 ANNEX H (informative) Sample USABILITY SPECIFICATION and its inputs 77 Annex I (informative) Recommended reading list .87 Annex J (informa
23、tive) Reference to the essential principles .95 Bibliography96 Index of defined terms 98 62366 IEC:2007 3 Figure A.1 A comparison of the RISK MANAGEMENT PROCESS (ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366) 24 Figure B.1 Categories of foreseeable USER action32 Figure D.1 A USER
24、INTERFACE design cycle .39 Figure D.2 Bubble diagram of the conceptual model of a physiological monitor52 Figure F.1 Pictorial representation of the relationship of HAZARD, sequence of events, HAZARDOUS SITUATION and HARM 65 Table D.1 Sample of design flaws and associated USE ERRORS 37 Table D.2 Map
25、ping of Figure D.1 to the subclauses of this International Standard .39 Table D.3 Examples of USER INTERFACE requirements 42 Table D.4 Typical deliverables .47 Table D.5 Examples of objective USABILITY goals .50 Table D.6 Examples of subjective USABILITY goals50 Table D.7 Examples of USER INTERFACE
26、modelling techniques 53 Table D.8 Characteristics of a typical USABILITY testing effort .53 Table F.1 Glossary of relevant RISK MANAGEMENT terms .64 Table F.2 Examples of HARM due to USABILITY related HAZARDS.65 Table G.1 Power on/off 70 Table G.2 Program pump.70 Table G.3 Start/stop infusion71 Tabl
27、e G.4 Monitor infusion status.72 Table G.5 Install and change set72 Table G.6 Priming73 Table G.7 Respond to and inactivate ALARM SIGNALSa73 Table G.8 Lockouts74 Table G.9 Power management.74 Table G.10 Preventative and routine maintenance .75 Table G.11 Basic operation76 Table G.12 Advanced functio
28、ns .76 Table J.1 Correspondence between this document and the essential principles .95 4 62366 IEC:2007 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL DEVICES APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide o
29、rganization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activiti
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35、 the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any medical device declared to be in conformity with an IEC Publication. 6) All users should ensure that
36、they have the latest edition of this publication. 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 natur
37、e whatsoever, whether direct or indirect, 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
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39、l Standard IEC 62366 has been prepared by a joint 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 cor
40、responding general aspects for medical devices. It is published as double logo standard. The text of this standard is based on the following documents: FDIS Report of voting62A/574/FDIS 62A/579/RVD Full information on the voting for the approval of this standard can be found in the report on voting
41、indicated in the above table. In ISO, the standard has been approved by 20 P-members out of 20 having cast a vote. 62366 IEC:2007 5 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 an
42、d definitions: roman type. Means to assess compliance: italic type. Informative material 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 ar
43、e 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 committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web s
44、ite under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. 6 62366 IEC:2007 INTRODUCTION Medical practice is increasingly using MEDICAL DEVICES for observation and treatme
45、nt of PATIENTS. USE ERRORS caused 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 inc
46、luding 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, difficult-to-use USER INTERFACE. The design of a usable MEDICAL DEVICE is a challenging endeavour, yet m
47、any organizations treat it as if it were just “common sense”. The design of the USER INTERFACE to achieve adequate (safe) USABILITY requires a very different skill set than that of the technical implementation of that interface. The USABILITY ENGINEERING PROCESS is intended to achieve reasonable USA
48、BILITY, 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 control by the MANUFACTURER. The USABILITY ENGINEERING PROCESS is related to the RISK MANAGEMENT PROCESS as indicated in Figure A.1. This Internati
49、onal Standard describes a USABILITY ENGINEERING PROCESS, and provides guidance on how to implement and execute the PROCESS to provide SAFETY in MEDICAL DEVICES. It is intended to be useful not only for MANUFACTURERS of MEDICAL DEVICES, but also for technical committees responsible for the preparation of particular MEDICAL DEVICE standards. 62366 IEC:2007 7 MED
