1、ANSI/AAMI/IEC 62366-1:2015Medical devices Part 1: Application of usability engineering to medical 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 pr
2、actice 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 ar
4、e 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 us
5、ed 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,
6、 warnings 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 repor
7、ting; 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
8、must 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 safel
9、y 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 i
10、s 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
11、such 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 s
12、tandard 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).
13、The 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
14、work 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, i
15、n 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 revi
16、ew 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 pro
17、visions. 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 po
18、tential 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“.
19、A 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
20、 and 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 conjunc
21、tion 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 Presid
22、ent, 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
23、appeals 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 devel
24、oped 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 Medical devices Part 1: Application of usability engineering to medical devices Approved 6 February 2015 by Associatio
25、n for the Advancement of Medical Instrumentation Approved 23 February 2015 by American National Standards Institute Abstract: This document specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engin
26、eering (human factors engineering) process permits the manufacturer to assess and mitigates risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. Keywords: human factors engineering, ergonomi
27、cs, human factors, usabilityANSI/AAMI/IEC 62366-1:2015(Partial revision of ANSI/AAMI/IEC 62366:2007(R)2013)Published by Association for the Advancement of Medical Instrumentation 4301 N Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2015 by the Association for the Advancement of Medi
28、cal Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by
29、 law. 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 written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil an
30、d criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI at 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 1-5702
31、0-584-1 Contents Page Glossary of equivalent standards iv Committee representation . v Background of ANSI/AAMI adoption of IEC 62366-1:2015 . vii Foreword viii Introduction. x 1 Scope . 1 2 Normative references 1 3 Terms and definitions 1 4 Principles 6 4.1 General requirements 6 4.2 USABILITY ENGIN
32、EERING FILE . 7 4.3 Tailoring of the USABILITY ENGINEERING effort . 7 5 USABILITY ENGINEERING PROCESS . 7 5.1 Prepare USE SPECIFICATION 7 5.2 Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS . 8 5.3 Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS 8 5.
33、4 Identify and describe HAZARD-RELATED USE SCENARIOS 8 5.5 Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION . 9 5.6 Establish USER INTERFACE SPECIFICATION 9 5.7 Establish USER INTERFACE EVALUATION plan 9 5.8 Perform USER INTERFACE design, implementation and FORMATIVE EVALUATION 11 5.
34、9 Perform SUMMATIVE EVALUATION of the USABILITY of the USER INTERFACE . 11 5.10 USER INTERFACE OF UNKNOWN PROVENANCE . 12 Annex A (informative) General guidance and rationale 13 Annex B (informative) Examples of possible HAZARDOUS SITUATIONS related to USABILITY 29 Annex C (normative) Evaluation of
35、a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) . 32 Annex D (informative) Types of MEDICAL DEVICE use, with examples . 34 Annex E (informative) Reference to the essential principles 36 Bibliography 37 Index of defined terms . 39 Glossary of equivalent standards International Standards adopted in the
36、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. NOTE: Documents are sorted by in
37、ternational 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 in 2009. Other normatively refere
38、nced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. www.aami.org/standards/glossary.pdf iv 2015 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 62366-1:2015 Committee representation Asso
39、ciation for the Advancement of Medical Instrumentation Human Factors Engineering Committee The adoption of IEC 62366-1 as an American National Standard was initiated by the AAMI Human Factors Engineering Committee (HE). AAMI HE functions as a U.S. sub-Technical Advisory Group to the relevant work in
40、 the International Electrotechnical Commission (IEC). U.S. representatives from AAMI HE played a very active part in developing the IEC standard. At the time this document was published, the AAMI Human Factors Engineering Committee had the following members: Cochairs: Mary Beth Privitera, University
41、 of Cincinnati Janine A. Purcell, MS, Philips Electronics North America Members: Tor Alden, BS MS, HS Design Inc Araya Amsalu, PhD, Hill-Rom Holdings Nancy Bayer, Smiths Medical Prashant Bhadri, CareFusion Sherri Biondi, PhD, Genentech Inc Peter Boge, Novo Nordisk Richard Botney, MD, Oregon Health a
42、ny IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standar
43、dization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has repr
44、esentation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IE
45、C cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publi
46、cations. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some area
47、s, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents includi
48、ng individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or relianc
49、e 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 publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 62366-1 has been prepared by a joint working group of subcommittee 62A: Common aspects of electrical medical e
