1、ANSI/AAMI/ISO 10993-9: 2009/(R)2014Biological evaluation of medical devices Part 9:Framework for identification and quantification ofpotential degradation productsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and po
2、tential uses of an AAMI 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 eff
3、ective application of current 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 obje
4、ctives and provided that 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 c
5、linical use, and the measurement 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, in
6、cluding performance characteristics, 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
7、specialized test methods 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
8、be provided and the reasons 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 p
9、ractices that will help 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 e
10、valuation. Similarly, even 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 performanc
11、e criteria, provide guidelines 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 understand
12、ing industrial practices. 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 adop
13、ted by government regulatory 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
14、 care professionals and 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.
15、 A standard or recommended 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
16、replace responsible decision-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 initiall
17、y developed and the specific 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
18、 to current procedures and 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
19、 will serve to identify 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 practi
20、ce should be analyzed in 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 recommende
21、d practice is truly useful 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
22、practices must be made in 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 repr
23、esentation of the Association 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
24、 standard or recommended 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 10993-9:2009/(R)2014 (Revision of ANSI/AAMI/IS
25、O 10993-9:1999/(R)2005) Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products Approved 8 March 2010 by Association for the Advancement of Medical Instrumentation Approved 17 May 2010 and Reaffirmed 23 September 2014 by Amer
26、ican National Standards Institute, Inc. Abstract: AAMI/AAMI/ISO 10993-9 provides general principles for the systematic evaluation of the potentialand observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can b
27、e used in the biological evaluation described in the ISO 10993 series. Considers both non-resorbable and resorbable materials. Not applicable to: a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are describ
28、ed in specific product standards, where available; b) leachable components which are not degradation products; c) medical devices or components that do not contact the patients body directly or indirectly. Keywords: biological evaluation, systemic evaluation, biodegradation, 10993-9 AAMI Standard Th
29、is 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 manufactur
30、ing, 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 procedures re
31、quire 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, or by visiting the AAMI website at www.aami.org. All AAMI standards, recom
32、mended 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
33、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, Suite 301 Arlington, VA 22203-1633 www.aami.org 2010 by the As
34、sociation 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 electronic retrieval system, without the prior written permissio
35、n 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 written permission of the Association for the Advancement
36、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 www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite
37、301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 276-0793. Printed in the United States of America ISBN 1-57020-384-9 Contents Page Glossary of equivalent standards iv Committee representation .vi Background of ANSI/AAMI adoption of ISO 10993-9:2009 .vii Forewordviii Introduction x 1
38、 Scope1 2 Normative references .1 3 Terms and definitions.2 4 Principles for design of degradation studies.3 4.1 General.3 4.2 Preliminary considerations3 4.3 Study design4 4.4 Characterization of degradation products from medical devices .4 5 Study report.5 Annex A (normative) Consideration of the
39、need for degradation studies .6 Annex B (informative) Biodegradation study considerations8 Bibliography .10 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that ha
40、s 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. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed
41、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 referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be co
42、nsidered 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 Fax: (703) 276-079
43、3. NOTEBeginning with the foreword on page ”viii”, this American National Standard is identical to ISO 10993-9:2009. 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 10993-9:2009 vii Foreword ISO (the International Organization for Standardization) is a worldwide federat
44、ion of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committe
45、e. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance
46、with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires app
47、roval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10993-9 was prepared by Technical Com
48、mittee ISO/TC 194, Biological evaluation of medical devices. This second edition cancels and replaces the first edition (ISO 10993-9:1999), which has been technically revised. ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: Part 1: Evaluat
49、ion and testing within a risk management process Part 2: Animal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and skin sensitization Part 11: Tests for systemic toxicity Part 12: Sample preparation a
