1、ANSI/AAMI/ISO 10993-13: 2010/(R)2014Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devicesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the object
2、ives and potential 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 s
3、afe and effective 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
4、 these objectives 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 d
5、evice for clinical 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
6、 device, including 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 deve
7、lopment of 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
8、tests must 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 proce
9、dures and practices 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 f
10、or device evaluation. 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
11、 performance 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
12、 understanding 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, th
13、ey are adopted 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 committe
14、e of health 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 pati
15、ent safety. 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 sh
16、ould never 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 w
17、as initially 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 recommend
18、ed practice 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
19、information 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 recomme
20、nded practice 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
21、 recommended 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 r
22、ecommended 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 offici
23、al and representation 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 expla
24、nation of a 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 10993-13:2010/(R)2014(Revision of A
25、NSI/AAMI/ISO 10993-13:1999/(R)2004) Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices Approved 14 October 2010 by Association for the Advancement of Medical Instrumentation Approved 26 October 2010 and Reaffirme
26、d 8 October 2014 by American National Standards Institute, Inc. Abstract: Describes general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. Keywords: biological evalua
27、tion, design, polymeric, degradationAAMI 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 the
28、y 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 be
29、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 the
30、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. Occasionally, v
31、oluntary 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, Suite 3
32、01 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 electroni
33、c 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 wri
34、tten 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 www.
35、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 1570203962 Contents PageGlossary of equivalent standards iv Committee representation .vi Background of ANSI/AAMI adoption of
36、ISO 10993-13:2010 .vii Forewordviii Introduction x 1 Scope1 2 Normative references .1 3 Terms and definitions.2 4 Degradation test methods2 4.1 General procedures 2 4.2 Accelerated degradation test.6 4.3 Real-time degradation test in a simulated environment.6 5 Test procedures 7 5.1 General.7 5.2 In
37、itial material characterization .7 5.3 Accelerated degradation test.7 5.4 Real-time degradation test in a simulated environment.10 6 Test report .11 Annex A (informative) Analytical methods 13 Annex B (informative) Environmental stress cracking (ESC) of polymers 14 Bibliography .16 Glossary of equiv
38、alent 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 and level of equivalency to the I
39、nternational Standard. 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 reaf
40、firmed 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 considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 AN
41、SI/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 b) buffer. NOTE See ISO 13781 for examples of buffers used in hydrolytic degradation studies. 2010 Association for the Advancement of Medical I
42、nstrumentation ANSI/AAMI/ISO 10993-13:2010 3 4.1.4.1.3 Test solutions for oxidative degradation For oxidative degradation, the following solutions are suggested: a) water and hydrogen peroxide, e.g. 3 % hydrogen peroxide solution, Pharmacopoeia grade; b) Fentons reagent mixture of dilute hydrogen pe
43、roxide solution and iron(II) salts, e.g. 100 mol Fe2+and 1 mmol H2O2. These oxidative solutions might not be stable at elevated temperatures or for a prolonged time. Therefore, the oxidative capacity shall be maintained in an appropriate range. This stability range shall be specified, justified and
44、reported. 4.1.4.2 Container Depending on the test solution, chemical grade glassware, polytetrafluoroethylene or polypropylene containers in an enclosed system shall be used. Controls shall be used in order to assess contaminants from the container. Evidence shall be provided that containers do not
45、interfere with the analysis. 4.1.4.3 Balance The balance used to determine mass loss shall be capable of weighing the initial sample mass with the precision required. For materials designed to be resorbed, a precision of 1 % is appropriate, for materials designed to resist degradation, a precision o
46、f at least 0.1 % shall be used. The precision of the balance for the final sample mass in the case of resorbable polymers shall be 0.1 %, and in the case of stable polymers 0.01 %, of the total sample mass. The precision and standard deviation of the method used for determining mass loss shall be st
47、ated in the test report. 4.1.4.4 Drying apparatus Any apparatus capable of drying the test samples to constant mass without contamination or loss of volatile degradation products shall be used. The apparatus shall be described and defined in the test report. 4.1.4.5 Vacuum source Any apparatus capab
48、le of producing a sufficient vacuum ( 0.5 kPa) in the drying apparatus is appropriate. The apparatus shall be described and defined in the test report. 4.1.4.6 Separation apparatus Any apparatus capable of separating the debris produced during the degradation study may be used. This can involve an i
49、nert filter, a temperature-controlled centrifuge or a combination thereof. The apparatus shall be described and defined in the test report. 4 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 10993-13:2010 4.1.5 Number of test samples At least three test samples shall be used for each test period. These should be the finished product itself or representative samples thereof. A separate container shall be used for each sample. One blank shall be used for each test period. If a valid statistical analysis is required, more samples at each test
