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1、Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 10993-12:2007 Biological evaluation of medical devices Part 12: Sample preparation and reference materials American National Standard Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under li
2、cense with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 02:08:27 MDTNo reproduction or networking permitted without license from IHS -,-,- Objectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses
3、 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 effective appli
4、cation 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 objectives and p
5、rovided 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 clinical use,
6、 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, including perf
7、ormance 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 specialized
8、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 be provided
9、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 practices tha
10、t 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 evaluation. S
11、imilarly, 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 performance criteria,
12、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 understanding industri
13、al 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 adopted by gover
14、nment 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 care profes
15、sionals 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. A standard
16、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 replace resp
17、onsible 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 initially developed
18、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 to current
19、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 will serve
20、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 practice should be
21、 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 recommended practice i
22、s 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 practices mu
23、st 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 representation o
24、f 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 standard or
25、 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. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license
26、with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 02:08:27 MDTNo reproduction or networking permitted without license from IHS -,-,- American National Standard ANSI/AAMI/ISO 10993-12:2007 (Revision of ANSI/AAMI/ISO 10993-12:2002) Biological evaluation of medical
27、 devices Part 12: Sample preparation and reference materials Approved 15 October 2007 by Association for the Advancement of Medical Instrumentation Approved 8 November 2007 by American National Standards Institute Abstract: Specifies requirements and gives guidance on the procedures to be followed i
28、n the preparation 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. Keywords: biological evaluation, sample preparation, reference materials, test sample Copyright Association for the Adv
29、ancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 02:08:27 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Standard This Association for the Advancement of Medical I
30、nstrumentation (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 manufacturing, marketing, purchasing, or using products,
31、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 require that action be taken to reaffirm, revise,
32、 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 reports, and other types of technical documents develope
33、d 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 authorities, in which case the adopting agency is responsible
34、 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 2007 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyr
35、ight 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 should be submitted to AAMI. It is illegal under federal law (17
36、 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 penalties, and damages of $100
37、,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-303-2 Copyright Association for the Advancem
38、ent of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 02:08:27 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Glossary of equivalent standards. iv Committee represe
39、ntation vi Background of AAMI Adoption of ISO 10993-12:2007 . vii Foreword viii Introduction x 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 General requirements. 3 5 Reference materials 4 5.1 General. 4 5.2 Certification of RMs for biological safety testing 4 6 Use of RMs as exp
40、erimental controls. 5 7 Test sample selection. 5 8 Test sample and RM preparation 5 9 Selection of representative portions from a device 6 10 Preparation of extracts of samples. 6 10.1 General. 6 10.2 Containers for extraction . 6 10.3 Extraction conditions and methods 7 10.4 Extraction conditions f
41、or hazard identification and risk estimation in the exaggerated-use condition 9 11 Records10 Annex A (informative) Experimental controls11 Annex B (informative) General principles on and practices of test sample preparation and sample selection13 Annex C (informative) Principles of test sample extra
42、ction.15 Bibliography.18 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 02:08:27 MDTNo reproduction or networking permitted without license from IHS -,-,- iv 20
43、07 Association for the Advancement of Medical Instrumentation ? ANSI/AAMI/ISO 10993-12:2007 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 b
44、y 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. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; ther
45、efore, this list should not be considered exhaustive. International designation 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 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 Identical IEC 60
46、601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and Amendment 1:1996 ANSI/AAMI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-2
47、1 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC 60601-2-50:2001 ANSI/AAMI/IEC 60601-2-50:2006 Identical IEC/TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical IEC 623
48、04:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006 ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 8637:2004 ANSI/AAMI RD16:2007 Ma
49、jor technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002 and Amendment 1:2006 Identical ISO 10993-5:1999