1、ANSI/AAMI/IEC 62366: 2007/(R)2013Medical devices Application of usability engineering tomedical devicesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended prac
2、tice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient care,
3、and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided that arbitrary and restrictive uses are
4、avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the measurement techniques that can be used
5、 to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance characteristics, instructions for use, w
6、arnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporti
7、ng; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for establishing the criteria mu
8、st be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help ensure that a device is used safely
9、and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, even though a recommended practice is
10、usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel on su
11、ch subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. In determining whether an AAMI sta
12、ndard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). Th
13、e application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial representatives, whose wo
14、rk has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice is limited, however, in
15、the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decision-making. Despite periodic review
16、 and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specific rationale for each of its provi
17、sions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practices. While observed or pote
18、ntial risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify a particular product as “unsafe“. A
19、voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the context of the specific needs a
20、nd resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly useful only when it is used in conjuncti
21、on with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the AAMI Vice Presiden
22、t, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association only upon exhaustion of any ap
23、peals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been develop
24、ed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI/IEC 62366:2007(R)2013 (Revision of ANSI/AAMI HE74:2001/(R)2009) Medical devices Application of usability engin
25、eering to medical devices Approved 14 October 2010 by Association for the Advancement of Medical Instrumentation Approved 25 October 2010 and reaffirmed 14 March 2013 by American National Standards Institute, Inc. Abstract: This standard describes a usability engineering process, and provides guidan
26、ce 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. Keywords: human factors engineerin
27、g, ergonomics, human factors, usability AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether
28、 they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may
29、 be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting
30、the AAMI website at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionall
31、y, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Sui
32、te 301 Arlington, VA 22203-1633 www.aami.org 2010 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an elect
33、ronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior
34、 written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at
35、www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 157020399-7 Contents Page Glossary of equivalent standards .v Committee representationvii Background of AAMI adoption of
36、IEC 62366:2007 .ix FOREWORD .x INTRODUCTION . xii 1 * Scope 1 2 Normative references . 1 3 Terms and definitions . 1 4 * Principles 5 4.1 General requirements 5 4.1.1 * USABILITY ENGINEERING PROCESS 5 4.1.2 RESIDUAL RISK 6 4.1.3 Information for SAFETY . 6 4.2 * USABILITY ENGINEERING FILE . 7 4.3 Sca
37、ling of the USABILITY ENGINEERING effort 7 5 * USABILITY ENGINEERING PROCESS . 7 5.1 * Application specification 7 5.2 * Frequently used functions . 8 5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY . 8 5.3.1 Identification of characteristics related to SAFETY 8 5.3.2 * I
38、dentification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS. 8 5.4 PRIMARY OPERATING FUNCTIONS. 9 5.5 * USABILITY SPECIFICATION 9 5.6 USABILITY VALIDATION plan.10 5.7 * USER INTERFACE design and implementation11 5.8 * USABILITY VERIFICATION .11 5.9 * USABILITY VALIDATION12 6 * ACCOMPANYIN
39、G DOCUMENT .12 7 * Training and materials for training .13 Annex A (informative) General guidance and rationale 14 Annex B (informative) Categories of USER action .27 Annex C (informative) Examples of USE ERRORS, ABNORMAL USE and possible causes .29 Annex D (informative) Guidance on the USABILITY EN
40、GINEERING PROCESS 32 ANNEX E (informative) Questions that can be used to identify MEDICAL DEVICE characteristics associated with USABILITY that could impact on SAFETY.58 ANNEX F (informative) Examples of possible USABILITY related HAZARDOUS SITUATIONS 62 Annex G (informative) USABILITY goals: Illust
41、rative example for a home parenteral infusion pump 66 ANNEX H (informative) Sample USABILITY SPECIFICATION and its inputs 78 Annex I (informative) Recommended reading list.89 Annex J (informative) Reference to the essential principles .98 Bibliography 99 Index of defined terms .102 Figure A.1 A comp
42、arison of the RISK MANAGEMENT PROCESS (ISO 14971:2007) and the USABILITY ENGINEERING PROCESS (IEC 62366)20 Figure B.1 Categories of foreseeable USER action .28 Figure D.1 A USER INTERFACE design cycle 35 Figure D.2 Bubble diagram of the conceptual model of a physiological monitor 49 Figure F.1 Picto
43、rial representation of the relationship of HAZARD, sequence of events, HAZARDOUS SITUATION and HARM .63 Table D.1 Sample of design flaws and associated USE ERRORS 34 Table D.2 Mapping of Figure D.1 to the subclauses of this International Standard36 Table D.3 Examples of USER INTERFACE requirements 3
44、8 Table D.4 Typical deliverables 44 Table D.5 Examples of objective USABILITY goals.47 Table D.6 Examples of subjective USABILITY goals .48 Table D.7 Examples of USER INTERFACE modelling techniques 50 Table D.8 Characteristics of a typical USABILITY testing effort.50 Table F.1 Glossary of relevant R
45、ISK MANAGEMENT terms .62 Table F.2 Examples of HARM due to USABILITY related HAZARDS.64 Table G.1 Power on/off.69 Table G.2 Program pump70 Table G.3 Start/stop infusion 71 Table G.4 Monitor infusion status72 Table G.5 Install and change set.73 Table G.6 Priming.73 Table G.7 Respond to and inactivate
46、 ALARM SIGNALSa74 Table G.8 Lockouts 75 Table G.9 Power management75 Table G.10 Preventative and routine maintenance.76 Table G.11 Basic operation.76 Table G.12 Advanced functions 77 Table J.1 Correspondence between this document and the essential principles98 Glossary of equivalent standards Intern
47、ational Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard.
48、 NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change
49、in 2009. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 and ANSI/AAMI ES60601-1:2005/A2:2010 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 any IEC National Committee interested in the subject dealt with may participate in this preparat
