1、ANSI/AAMI/ISO 10993-12: 2012Biological evaluation of medical devices Part 12: Sample preparation and reference materialsAmerican 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
2、 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 current technologies
3、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 arbitrary and rest
4、rictive 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
5、 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 characteristics, instru
6、ctions 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 unif
7、ormity 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 establishin
8、g 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 ensure that a devic
9、e 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, even though a recomme
10、nded 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 industria
11、l 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. In determining wh
12、ether 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
13、 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 industrial represen
14、tatives, 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 limi
15、ted, 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. Despit
16、e 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 specific rationale for
17、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 and practices. While
18、 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 a particular produc
19、t 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 the context of the
20、 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 useful only when it is
21、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 in writing, to the A
22、AMI 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 exh
23、austion 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
24、 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 10993-12:2012 (Revision of ANSI/AAMI/ISO 10993-12:2007) Biological evaluation of medical
25、devices Part 12: Sample preparation and reference materials Approved 20 July 2012 by Association for the Advancement of Medical Instrumentation Approved 26 July 2012 by American National Standards Institute Abstract: Specifies requirements and gives guidance on the procedures to be followed in the p
26、reparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Includes extraction procedures and soluble polymer procedures. Keywords: sample preparation, reference material AAMI Standard
27、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 manufact
28、uring, 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
29、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, or by visiting the AAMI website at www.aami.org. All AAMI standards, rec
30、ommended 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 governmen
31、t 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 2012 by the
32、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 electronic retrieval system, without the prior written permiss
33、ion 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 Advancemen
34、t 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 at 4301 N. Fairfax Drive, Su
35、ite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-450-0 Contents Page Glossary of equivalent standards . iv Committee representation vii Background of ANSI/AAMI adoption of ISO 10993-12:2012 ix Foreword x Introductio
36、n . xii 1 Scope. 1 2 Normative references . 1 3 Terms and definitions . 2 4 General requirements . 4 5 Reference materials (RMs) . 4 5.1 General . 4 5.2 Certification of RMs for biological safety testing 5 6 Use of RMs as experimental controls . 5 7 Test sample selection . 5 8 Test sample and RM pre
37、paration 5 9 Selection of representative portions from a device 6 10 Preparation of extracts of samples . 7 10.1 General . 7 10.2 Containers for extraction . 7 10.3 Extraction conditions and methods . 7 10.4 Extraction conditions for hazard identification and risk estimation in the exaggerated-use c
38、ondition (points to consider in relation to Annex D) . 10 11 Records 11 Annex A (informative) Experimental controls 12 Annex B (informative) General principles on, and practices of, test sample preparation and sample selection 14 Annex C (informative) Principles of test sample extraction 16 Annex D
39、(informative) Exhaustive extraction of polymeric materials for biological evaluation 19 Bibliography . 22 iv 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 10993-12:2012 Glossary of equivalent standards International Standards adopted in the United States may include n
40、ormative 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. Th
41、e 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 reaffirmed without change in 2009. Other normatively referenced International Standard
42、s 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/(R)2012 Major technical variations IEC 60601-1:2005/A1:2012 ANSI/AAMI ES60601-1:2005/A1:2
43、012 A1 identical IEC Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) C1 identical to Corrigendum 1 selection of representative portions from a device; test sample preparation; experimental controls; selection of, and requirements, for reference materials; preparation of
44、 extracts. This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated refer
45、ences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993 (all parts), Biological evaluation of medical devices ISO 14971, Medical devices Application of risk management to medical devices 2 2012 Associa
46、tion for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 10993-12:2012 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accelerated extraction extraction that provides a measure of the leachable or extractable materials of the device
47、or material, using conditions that shorten the time for leaching of the substances into the extraction vehicle but do not result in a chemical change of the substances being extracted EXAMPLE Elevated temperature, agitation, changing of the extraction vehicle. 3.2 blank extraction vehicle not contai
48、ning the test material, which is retained in a vessel identical to that holding the test sample and subjected to conditions identical to the ones the test sample is subjected to during its extraction NOTE The purpose of the blank is to evaluate possible confounding effects due to the extraction vess
49、el, extraction vehicle and extraction process. 3.3 CRM certified reference material reference material, accompanied by a certificate, one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence ISO Guide 30:1992, definition 2.2 3.4 exaggerated extraction extraction that is intended to result in a greater amount of a chemical const
