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1、American National Standard ANSI/AAMI/ISO 10993-17:2002 AAMI Association for the Advancement of Medical Instrumentation Biological evaluation of medical devices Part 17: Methods for the establishment of allowable limits for leachable substances Copyright Association for the Advancement of Medical Ins
2、trumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:22:00 MDTNo reproduction or networking permitted without license from IHS -,-,- The Objectives and Uses of AAMI Standards and Recommended Practices It is most impor
3、tant that the objectives 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 continu
4、ed increase in the safe 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 draft
5、ed with attention to 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 con- sider
6、ed in qualifying the device 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 per- formance characteristics of different products. Some standards em- phasize the information that s
7、hould be provided with the 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 o
8、ften necessitates the development 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 perf
9、ormance criteria, referee 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 performanc
10、e per se, but rather procedures 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 manufac- turer, it may also be of value to the potential purchaser or user of the devi
11、ce as a fume of reference for device evaluation. 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,
12、 while not addressing device 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
13、health care professionals in 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 volu
14、ntary (unless, of course, they are adopted 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 coll
15、ective expertise of a committee 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, u
16、ltimately, to help ensure patient 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 responsi
17、ble decision-making, but it should never replace 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 t
18、he reasons why the document was 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
19、, and in applying a recommended 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 eq
20、uip- ment. No single source of 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 consi
21、derations. Similarly, a recommended 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 provi
22、sion. In summary, a standard or 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 interpre
23、tations of AAMI standards and recommended practices 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
24、 become official and representation of the 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 character
25、ization or explanation 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. Copyright Association for the Advancement of Medical Instrum
26、entation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:22:00 MDTNo reproduction or networking permitted without license from IHS -,-,- American National StandardANSI/AAMI/ISO 10993-17:2002 Biological evaluation of medical d
27、evices Part 17: Establishment of allowable limits for leachable substances Approved 15 November 2002 by Association for the Advancement of Medical Instrumentation Approved 17 December 2002 by American National Standards Institute Abstract:Specifies the method to be used to determine allowable limits
28、 for leachable substances 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=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/
29、2007 02:22:00 MDTNo reproduction or networking 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
30、does not in any respect preclude anyone, 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
31、editions. CAUTION NOTICE: This AAMI standard 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 standard
32、s by calling or writing AAMI. 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
33、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 1110 N Glebe Road, Suite 220 A
34、rlington, VA 22201-4795 2003 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 electronic retrieval syste
35、m, 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 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 t
36、he 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, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22
37、201-4795. Phone: (703) 525-4890; Fax: (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=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 0
38、2:22:00 MDTNo reproduction or networking permitted without 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 definitions
39、1 4General principles for establishing allowable limits.3 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 5.3Collec
40、tion and evaluation of data.6 5.4Set TI for noncancer endpoints7 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 wei
41、ght-of-evidence test.9 5.5.3Procedure when weight-of-evidence 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 to
42、lerable exposure (TE)11 6.1General11 6.2Exposure population 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
43、 factor (PEF) .12 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:22:00 MDTNo reproduction or networking permitted without license from IHS -,-,- 6.4Tolerab
44、le exposure 13 7Feasibility evaluation.13 8Benefit evaluation .13 9Allowable 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
45、 surface contact to maximum dose to patient from a medical device18 DRisk analysis 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=IHS
46、Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:22:00 MDTNo reproduction or 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 standard
47、s 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 international standard. (Note: Document
48、s are sorted by international designation.) Other normatively referenced international standards 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-
49、1-2:2001Identical IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 b) determining 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