1、ANSI/AAMI/ISO 10993-1: 2009/(R)2013Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI
2、product standard or recommended practice 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 cu
3、rrent technologies to patient care, 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
4、 arbitrary and restrictive uses are 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 mea
5、surement techniques that can be used 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 char
6、acteristics, instructions for use, 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
7、 to facilitate uniformity in reporting; 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 reas
8、ons for establishing the criteria 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
9、ensure that a device is used safely 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, ev
10、en though a recommended practice is 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 guid
11、elines to industrial personnel on 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
12、. In determining whether an AAMI standard 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 regula
13、tory or procurement authorities). 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
14、industrial representatives, whose 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 recommend
15、ed practice is limited, however, in 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 deci
16、sion-making. Despite periodic review 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 spec
17、ific rationale for each of its provisions. 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 a
18、nd practices. While observed or potential 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
19、a particular product as “unsafe“. 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
20、 the context of the specific needs 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 usef
21、ul only when it is used in conjunction 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 i
22、n writing, to the AAMI Vice President, 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 Associ
23、ation only upon exhaustion of any 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
24、 practice which has not been developed 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/ISO 10993-1:2009/(R)2013 (Revision of ANSI/AAMI/ISO 10993-1:2003) Biologic
25、al evaluation of medical devices Part 1: Evaluation and testing within a risk management process Approved 3 September 2009 by Association for the Advancement of Medical Instrumentation Approved 8 October 2009 and reaffirmed 2 December 2013 by American National Standards Institute Abstract: Describes
26、 the general principles governing the biological evaluation of medical devices within a risk management framework; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of g
27、aps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyze the biological safety of the medical device; and the assessment of the biological safety of the medical device. Keywords: biological evaluation, risk management AAMI Standar
28、d 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 approved the standard or not, from manufa
29、cturing, 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 withdrawn at any time. AAMI procedure
30、s require that action be taken to reaffirm, revise, or withdraw this standard no later than 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommended practices, technical information repor
31、ts, 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 regulatory agencies or procurement authoritie
32、s, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 1110 N Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2009 by the Association for the Advancement of Medical Instrume
33、ntation 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 electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this draft
34、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 of Medical Instrumentation. Violators risk legal act
35、ion, 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 www.aami.org or contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; F
36、ax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-370-9 Contents Page Glossary of equivalent standards iv Committee representation .vi Background of ANSI/AAMI adoption of ISO 10993-1:2009 viii Forewordix Introduction .xi 1 Scope1 2 Normative references .1 3 Terms and definitio
37、ns.2 4 General principles applying to biological evaluation of medical devices 4 5 Categorization of medical devices7 5.1 General.7 5.2 Categorization by nature of body contact7 5.3 Categorization by duration of contact 9 6 Biological evaluation process .9 6.1 Material characterization9 6.2 Biologic
38、al evaluation tests.10 7 Interpretation of biological evaluation data and overall biological safety assessment 15 Annex A (informative) Biological evaluation tests17 Annex B (informative) Guidance on the risk management process .18 Annex C (informative) Suggested procedure for literature review21 Bi
39、bliography .24 Glossary of equivalent standards International 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 a
40、nd level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designati
41、on U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2009 ANSI/AAMI/IEC 60601-2-2:2009 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:20
42、09 ANSI/AAMI/IEC 60601-2-19:2009 Identical IEC 60601-2-20:2009 ANSI/AAMI/IEC 60601-2-20:2009 Identical IEC 60601-2-21:2009 ANSI/AAMI/IEC 60601-2-21:2009 Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004/(R)2009 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variat
43、ions IEC 60601-2-50:2009 ANSI/AAMI/IEC 60601-2-50:2009 Identical IEC 80601-2-30:2009 ANSI/AAMI/IEC 80601-2-30:2009 Identical (with inclusion) IEC 80601-2-58:2008 ANSI/AAMI/IEC 80601-2-58:2008 Identical IEC/TR 60878:2009 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2009 ANSI/AAMI/IEC TIR62296:2
44、009 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006ANSI/AAMI/IEC TIR62348:2006 Identical IEC/TR 80002-1:2009 ANSI/IEC/TR 80002-1:2009 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:2009 ANS
45、I/AAMI/ISO 7199:2009 Identical ISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2009 ANSI/AAMI/ISO 10993-1:2009 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:
46、2003/(R)2009 Identical ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002/(R)2009 and Amendment 1:2006/(R)2009 Identical ISO 10993-5:2009 ANSI/AAMI/ISO 10993-5:2009 Identical ISO 10993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical ISO 10993-7:2008 ANSI/AAMI/ISO 10993-7:2008 Identical ISO
47、 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999/(R)2005 Identical ISO 10993-10:2002 and Amendment 1:2006 ANSI/AAMI BE78:2002/(R)2008 ANSI/AAMI BE78:2002/A1:2006/(R)2008 Minor technical variations Identical ISO 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identical ISO 10993-12:2007 ANSI/AAMI/ISO 10993-12:2007
48、 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001/(R)2006 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000/(R)2006 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2009 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 1
49、0993-17:2002/(R)2008 Identical ISO 10993-18:2005 ANSI/AAMI BE83:2006 Major technical variations ISO/TS 10993-19:2006 ANSI/AAMI/ISO TIR10993-19:2006 Identical ISO/TS 10993-20:2006 ANSI/AAMI/ISO TIR10993-20:2006 Identical ISO 11135-1:2007 ANSI/AAMI/ISO 11135-1:2007 Identical ISO/TS 11135-2:2008 ANSI/AAMI/ISO TIR11135-2:2008 Identical ISO 11137-1:2006ANSI/AAMI/ISO 11137-1:2006 Identical iv 2009 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 10993-1:2009 International designation U.S. designation Equivalency ISO 11137-2:2006 (2006-08-01 corrected version)AN
