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1、Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 10993-17:2002/(R)2008 Biological evaluation of medical devices Part 17: Methods for the establishment of allowable limits for leachable substances Copyright Association for the Advancement of Medical Instrumentation Provided by
2、 IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 02/01/2009 00:40:49 MSTNo reproduction or networking permitted without license from IHS -,-,- The 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 con- sidered in qualifying the device for clinical us
6、e, 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 per- formance characteristics of different products. Some standards em- phasize the information that should be provided with the device, includin
7、g 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 specia
8、lized 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 pro
9、vided 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 practic
10、es 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 manufac- turer, it may also be of value to the potential purchaser or user of the device as a fume of reference for device evalua
11、tion. Similarly, even though a recommended practice is usually oriented towards health care 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 cr
12、iteria, 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
13、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 adopted
14、by government regulatory or procurement authorities). The application of a standard or recom- mended 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 c
15、are 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. A
16、 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 re
17、place responsible decisionmaking. 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 d
18、eveloped 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
19、 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 equip- ment. No single source of information
20、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 practic
21、e 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 recommended
22、 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 p
23、ractices must be made in writing, to the Manager for Technical Development. 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
24、Association only upon exhaustion of any appeals and upon publication of notice of interpre- tation 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 rec
25、ommended 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 with
26、 AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 02/01/2009 00:40:49 MSTNo reproduction or networking permitted without license from IHS -,-,- American National Standard ANSI/AAMI/ISO 10993-17:2002/(R)2008 Biological evaluation of medical devices Part 17: Establishment of allowable limits for
27、 leachable substances Approved 15 November 2002 by Association for the Advancement of Medical Instrumentation Approved 17 December 2002 and reaffirmed 3 December 2008 by American National Standards Institute Abstract: Specifies the method to be used to determine allowable limits for leachable substa
28、nces in medical devices. Keywords: biological evaluation, medical devices, leachable substances Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 02/01/2009 00:40:49 MSTNo reproduction or net
29、working permitted without license from IHS -,-,- 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
30、, whether they 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 sta
31、ndard may be revised or withdrawn at any time. AAMI procedures 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. All AAMI
32、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, voluntary technical documents are adopte
33、d 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 1110 N Glebe Road, Suite 220 Arlington, VA 22201-4795 2003 by the Ass
34、ociation 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 permission
35、 of AAMI. All requests pertaining to this draft 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 of M
36、edical 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, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (
37、703) 525-1067. Printed in the United States of America ISBN 1570201781 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 02/01/2009 00:40:49 MSTNo reproduction or networking permitted without
38、 license from IHS -,-,- Contents Page Glossary of equivalent standards.v Committee representationvii Background of ANSI/AAMI adoption of ISO 10993-17:2002. viii Foreword.ix Introduction x 1Scope1 2Normative reference .1 3Terms and definitions1 4General principles for establishing allowable limits.3
39、5Establishment of tolerable intake (TI) for specific leachable substances5 5.1General5 5.2Exposure considerations for TI calculation.5 5.2.1Data used 5 5.2.2Exposure duration considerations5 5.2.3Considerations of route of exposure6 5.3Collection and evaluation of data.6 5.4Set TI for noncancer endp
40、oints7 5.4.1General7 5.4.2Determination of uncertainty factors 7 5.4.3Determination of the modifying factor 8 5.5Set TI for cancer endpoints8 5.5.1Procedure for carcinogenic leachable substances.8 5.5.2Options for substances that pass the weight-of-evidence test.9 5.5.3Procedure when weight-of-evide
41、nce test fails or is equivocal9 5.6Establishment of tolerable contact levels (TCLs) .9 5.6.1General9 5.6.2Exposure consideration for TCL calculation.9 5.6.3Set TCL for irritation endpoint9 5.7Risk assessment of mixtures .10 6Calculation of tolerable exposure (TE)11 6.1General11 6.2Exposure populatio
42、n 11 6.2.1Body mass.11 6.2.2Devices specifically intended for use in neonates and children.11 6.3Calculation of utilization factor from intended use pattern11 6.3.1General11 6.3.2Concomitant exposure factor (CEF) 12 6.3.3Proportional exposure factor (PEF) .12 Copyright Association for the Advancemen
43、t of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 02/01/2009 00:40:49 MSTNo reproduction or networking permitted without license from IHS -,-,- 6.4Tolerable exposure 13 7Feasibility evaluation.13 8Benefit evaluation .13 9Allowable
44、limits .13 10Reporting requirements 14 Annexes ASome typical assumptions for biological parameters15 BRisk assessment for mixtures of leachable substances17 CConversion of allowable limits for systemic exposure and for body surface contact to maximum dose to patient from a medical device18 DRisk ana
45、lysis report.20 Bibliography .21 Figure 1Establishment of allowable limits for leachable substances4 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 02/01/2009 00:40:49 MSTNo reproduction o
46、r networking permitted without license from IHS -,-,- 2003 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI/ISO 10993-17:2002v Glossary of equivalent standards International standards adopted in the United States may include normative references to other international standards
47、. 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.) Other normatively referenced international standards
48、 may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designationU.S. designationEquivalency IEC 60601-1-2:2001ANSI/AAMI/IEC 60601-1-2:2001Identical IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 b) determini
49、ng the tolerable exposure (TE) of the patient to the leachable substance (see clause 6) by determining appropriate patient body mass (mB), and modifying the product of tolerable intake and body mass based upon a device utilization factor (UTF); c) determining feasibility and applying benefit when appropriate. If the f