1、ANSI/AAMI/ISO 10993-6: 2016Biological evaluation of medical devicesPart 6: Tests for local effects after implantationAmerican 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 re
2、commended 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 current technologies to
3、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 arbitrary and restric
4、tive 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 measurement techniques th
5、at 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 characteristics, instructi
6、ons 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 to facilitate uniform
7、ity 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 reasons for establishing t
8、he 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 ensure that a device i
9、s 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, even though a recommende
10、d 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 guidelines to industrial p
11、ersonnel 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. In determining wheth
12、er 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 regulatory or procurement au
13、thorities). 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 representat
14、ives, 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 recommended practice is limited
15、, 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 decision-making. Despite p
16、eriodic 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 specific rationale for eac
17、h 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 and practices. While ob
18、served 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 a particular product a
19、s “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 the context of the sp
20、ecific 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 useful only when it is use
21、d 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 in writing, to the AAMI
22、 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 Association only upon exhaus
23、tion 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 practice which has no
24、t 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 10993-6:2016 Biological evaluation of medical devicesPart 6: Tests for local effects after i
25、mplantation Approved 15 December 2016 by AAMI Approved 10 January 2017 by American National Standards Institute Abstract: Specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. Keywords: biological evaluation, implantati
26、on 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 approved the standard or n
27、ot, 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 withdrawn at any time.
28、 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, recommended practices, technical
29、 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 regulatory agencies or proc
30、urement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by AAMI 4301 N. Fairfax Dr., Suite. 301 Arlington, VA 22203-1633 www.aami.org 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This
31、publication is subject to copyright claims of ISO 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 document should be submitted to AAMI. It is il
32、legal 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 and criminal pen
33、alties, 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 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 276-0793. Printed in the
34、 United States of America ISBN 978-1-57020-668-9 Contents PageGlossary of equivalent standards iv Committee representation . v Background of AAMI adoption of ISO 10993-6:2016 . vii Foreword viii 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Common provisions for implantation test me
35、thods . 2 5 Test methods, general aspects 3 6 Test report 9 Annex A (normative) Test methods for implantation in subcutaneous tissue . 11 Annex B (normative) Test method for implantation in muscle 13 Annex C (normative) Test method for implantation in bone 15 Annex D (normative) Test method for impl
36、antation in brain tissue . 18 Annex E (informative) Examples of evaluation of local biological effects after implantation . 23 Bibliography . 27 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 10993-6:2016 Glossary of equivalent standards International Standards adopt
37、ed in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and
38、 level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 10993-6:2016 v Committee representation Association for the Advancement of Medical Instrumentation Biological Evaluation Committee The
39、 adoption of ISO 10993-6 as an American National Standard was initiated by the AAMI Implantation Working Group of the AAMI Biological Evaluation Committee, which also functions as a U.S. Technical Advisory Group to relevant work in the International Organization for Standardization (ISO). U.S. repre
40、sentatives from the AAMI Working Group played an active part in developing the ISO standard. At the time this document was published, the AAMI Biological Evaluation Committee had the following members: Cochairs: Ronald Brown Jon Cammack, PhD Members: James Anderson, PhD, Case Western Reserve Univers
41、ity Ronald Brown, FDA/CDRH Jon Cammack, PhD, Nevakar LLC Joseph Carraway, PhD, NAMSA Gloria Frost, PhD, Cardinal Health Philippe Hasgall, PhD, Zimmer Inc Todd Kennedy, PhD, WL Gore b) new Annex D.ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devi
42、ces: Part 1: Evaluation 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 6: Tests for local effects after implantation Part 7: Ethylen
43、e oxide sterilization residuals Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and skin sensitization 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 10993-6:2016 ix Part 11: Tests for systemic toxi
44、city Part 12: Sample preparation and reference materials Part 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation produc
45、ts from metals and alloys Part 16: Toxicokinetic study design for degradation products and leachables Part 17: Establishment of allowable limits for leachable substances Part 18: Chemical characterization of materials Part 19: Physico-chemical, morphological and topographical characterization of mat
46、erials Technical specification Part 20: Principles and methods for immunotoxicology testing of medical devices Technical specification Part 33: Guidance on tests to evaluate genotoxicitySupplement to ISO 10993 3 Technical Report The following parts are under preparation: Part 5: Tests for in vitro c
47、ytotoxicity 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 10993-6:2016 1 American National Standard ANSI/AAMI/ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation 1 Scope This part of ISO 10993 specifies test meth
48、ods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to materials that are solid and non-absorbable, non-solid, such as porous materials, liquids, gels, pastes, and particulates, and degradable and/or absor
49、bable, which may be solid or non-solid. The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached, in order to eval
