1、 American National Standard ANSI/AAMI/IEC 62304:2006Medical device software Software life cycle processes The Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and potential uses of an AAMIproduct standard or recommended practice are clearly under
2、stood.The objectives of AAMIs technical development program derivefrom AAMIs overall mission: the advancement of medicalinstrumentation. Essential to such advancement are (1) a continuedincrease in the safe and effective application of current technologiesto patient care, and (2) the encouragement o
3、f new technologies. It isAAMIs view that standards and recommended practices cancontribute significantly to the advancement of medicalinstrumentation, provided that they are drafted with attention to theseobjectives and provided that arbitrary and restrictive uses are avoided.A voluntary standard fo
4、r a medical device recommends to themanufacturer the information that should be provided with or on theproduct, basic safety and performance criteria that should be con-sidered in qualifying the device for clinical use, and the measurementtechniques that can be used to determine whether the device c
5、onformswith the safety and performance criteria and/or to compare the per-formance characteristics of different products. Some standards em-phasize the information that should be provided with the device,including performance characteristics, instructions for use, warningsand precautions, and other
6、data considered important in ensuring thesafe and effective use of the device in the clinical environment.Recommending the disclosure of performance characteristics oftennecessitates the development of specialized test methods to facilitateuniformity in reporting; reaching consensus on these tests c
7、anrepresent a considerable part of committee work. When a draftingcommittee determines that clinical concerns warrant the establishmentof minimum safety and performance criteria, referee tests must beprovided and the reasons for establishing the criteria must bedocumented in the rationale.A recommen
8、ded practice provides guidelines for the use, care,and/or processing of a medical device or system. A recommendedpractice does not address device performance per se, but ratherprocedures and practices that will help ensure that a device is usedsafely and effectively and that its performance will be
9、maintained.Although a device standard is primarily directed to the manufac-turer, it may also be of value to the potential purchaser or user of thedevice as a fume of reference for device evaluation. Similarly, eventhough a recommended practice is usually oriented towards healthcare professionals, i
10、t may be useful to the manufacturer in betterunderstanding the environment in which a medical device will beused. Also, some recommended practices, while not addressing deviceperformance criteria, provide guidelines to industrial personnel onsuch subjects as sterilization processing, methods of coll
11、ecting data toestablish safety and efficacy, human engineering, and otherprocessing or evaluation techniques; such guidelines may be useful tohealth care professionals in understanding industrial practices.In determining whether an AAMI standard or recommendedpractice is relevant to the specific nee
12、ds of a potential user of thedocument, several important concepts must be recognized:All AAMI standards and recommended practices are voluntary(unless, of course, they are adopted by government regulatory orprocurement authorities). The application of a standard or recom-mended practice is solely wi
13、thin the discretion and professionaljudgment of the user of the document.Each AAMI standard or recommended practice reflects thecollective expertise of a committee of health care professionals andindustrial representatives, whose work has been reviewed nationally(and sometimes internationally). As s
14、uch, the consensusrecommendations embodied in a standard or recommended practiceare intended to respond to clinical needs and, ultimately, to helpensure patient safety. A standard or recommended practice is limited,however, in the sense that it responds generally to perceived risks andconditions tha
15、t may not always be relevant to specific situations. Astandard or recommended practice is an important reference inresponsible decision-making, but it should never replace responsibledecision-making.Despite periodic review and revision (at least once every fiveyears), a standard or recommended pract
16、ice is necessarily a staticdocument applied to a dynamic technology. Therefore, a standardsuser must carefully review the reasons why the document wasinitially developed and the specific rationale for each of itsprovisions. This review will reveal whether the document remainsrelevant to the specific
17、 needs of the user.Particular care should be taken in applying a product standard toexisting devices and equipment, and in applying a recommendedpractice to current procedures and practices. While observed orpotential risks with existing equipment typically form the basis for thesafety and performan
18、ce criteria defined in a standard, professionaljudgment must be used in applying these criteria to existing equip-ment. No single source of information will serve to identify aparticular product as “unsafe“. A voluntary standard can be used asone resource, but the ultimate decision as to product saf
19、ety andefficacy must take into account the specifics of its utilization and, ofcourse, cost-benefit considerations. Similarly, a recommendedpractice should be analyzed in the context of the specific needs andresources of the individual institution or firm. Again, the rationaleaccompanying each AAMI
20、standard and recommended practice is anexcellent guide to the reasoning and data underlying its provision.In summary, a standard or recommended practice is truly usefulonly when it is used in conjunction with other sources of informationand policy guidance and in the context of professional experien
21、ce andjudgment.INTERPRETATIONS OF AAMI STANDARDSAND RECOMMENDED PRACTICESRequests for interpretations of AAMI standards and recommendedpractices must be made in writing, to the Manager for TechnicalDevelopment. An official interpretation must be approved by letterballot of the originating committee
22、and subsequently reviewed andapproved by the AAMI Standards Board. The interpretation willbecome official and representation of the Association only uponexhaustion of any appeals and upon publication of notice of interpre-tation in the “Standards Monitor“ section of the AAMI News. TheAssociation for
23、 the Advancement of Medical Instrumentationdisclaims responsibility for any characterization or explanation of astandard or recommended practice which has not been developed andcommunicated in accordance with this procedure and which is notpublished, by appropriate notice, as an official interpretat
24、ion in theAAMI News.American National Standard ANSI/AAMI/IEC 62304:2006 (Revision of ANSI/AAMI SW68:2001) Medical device software Software life cycle processes Approved 8 June 2006 by Association for the Advancement of Medical Instrumentation Approved 17 July 2006 by American National Standards Inst
25、itute, Inc. Abstract: Defines the life cycle requirements for medical device software. The set of processes, activities and tasks described in this standard establishes a common framework for medical device software life cycle processes. Keywords: software, medical device, software life cycle proces
26、ses, software engineering 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 they have app
27、roved 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 be revised or
28、 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. All AAMI standards, recommend
29、ed 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. Occasionally, voluntary technical documents are adopted by government regu
30、latory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Copyright information Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2006 by the
31、Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of IEC, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permiss
32、ion of AAMI. All requests pertaining to this draft 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 written permission of the Association for the Advancement o
33、f 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, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax
34、: (703) 525-1067. Printed in the United States of America ISBN 1570202583 CONTENTS Glossary of equivalent standards.v Committee representation vii Background of AAMI adoption of IEC 60234:2006 .ix FOREWORD x INTRODUCTION xii 1 Scope . 1 1.1 * Purpose . 1 1.2 * Field of application. 1 1.3 Relationshi
35、p to other standards . 1 1.4 Compliance 1 2 * Normative references. 2 3 * Terms and definitions. 2 4 * General requirements 6 4.1 * Quality management system. 6 4.2 * RISK MANAGEMENT 7 4.3 * Software safety classification 7 5 Software development PROCESS 8 5.1 * Software development planning 8 5.2 *
36、 Software requirements analysis 10 5.3 * Software ARCHITECTURAL design 12 5.4 * Software detailed design . 13 5.5 * SOFTWARE UNIT implementation and verification . 13 5.6 * Software integration and integration testing 14 5.7 * SOFTWARE SYSTEM testing 15 5.8 * Software release 16 6 Software maintenan
37、ce PROCESS 18 6.1 * Establish software maintenance plan 18 6.2 * Problem and modification analysis 18 6.3 * Modification implementation 19 7 * Software RISK MANAGEMENT PROCESS 20 7.1 * Analysis of software contributing to hazardous situations. 20 7.2 RISK CONTROL measures 20 7.3 VERIFICATION of RISK
38、 CONTROL measures. 21 7.4 RISK MANAGEMENT of software changes. 21 8 * Software configuration management PROCESS 22 8.1 * Configuration identification 22 8.2 * Change control 22 8.3 * Configuration status accounting 23 9 * Software problem resolution PROCESS. 23 9.1 Prepare PROBLEM REPORTS 23 9.2 Inv
39、estigate the problem 23 9.3 Advise relevant parties.24 9.4 Use change control process 24 9.5 Maintain records 24 9.6 Analyse problems for trends 24 9.7 Verify software problem resolution 24 9.8 Test documentation contents. 24 Annex A (informative) Rationale for the requirements of this standard 25 A
40、nnex B (informative) Guidance on the provisions of this standard . 28 Annex C (informative) Relationship to other standards 42 Annex D (informative) Implementation 63 Bibliography. 65 Index of defined terms. 66 Figure 1 Overview of software development PROCESSES and ACTIVITIES . xiii Figure 2 Overvi
41、ew of software maintenance PROCESSES and ACTIVITIES. xiii Figure B.1 Example of partitioning of SOFTWARE ITEMS 32 Figure C.1 Relationship of key MEDICAL DEVICE standards to IEC 62304. 42 Figure C.2 Software as part of the V-model. 45 Figure C.3 Application of IEC 62304 with IEC 61010-1 . 55 Table A.
42、1 Summary of requirements by software safety class 27 Table B.1 Development (model) strategies as defined at ISO/IEC 12207. 29 Table C.1 Relationship to ISO 13485:2003 43 Table C.2 Relationship to ISO 14971:2000 . 44 Table C.3 Relationship to IEC 60601-1 47 Table C.4 Relationship to IEC 60601-1-4 52
43、 Table C.5 Relationship to ISO/IEC 12207 57 Table D.1 Checklist for small companies without a certified QMS 64 2006 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 62304:2006 v Glossary of equivalent standards International Standards adopted in the United States may include
44、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 international designation. O
45、ther 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 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-
46、2:2001 and Amendment 1:2004 ANSI/AAMI/IEC 60601-1-2:2001 and Amendment 1:2004 Identical IEC 60601-2-04:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and Amendment 1:1996 ANSI/AAMI II51:2
47、004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC/TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2003 ANSI/AAMI/
48、IEC TIR62296:2003 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:200x1 ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical
49、ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:200x2Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 ANSI/AAMI/ISO 10993-4:2002 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:1994 ANSI/AAMI/ISO 10993-6:1995/(R)2001 Identical ISO 10993-7:1995 ANSI/AAMI/ISO 10993-7:1995/(R)2001 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999/(R)2005 Identical ISO 10993-10:2002 and Amendment 1:2006 ANSI/AAMI BE78:2002 ANSI/AAMI BE78:2002/A1:2006 Minor technic
