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1、American National Standard ANSI/AAMI BE78:2002 AAMI Association for the Advancement of Medical Instrumentation Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity Copyright Association for the Advancement of Medical Instrumentation Provided by IHS
2、 under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:39:16 MDTNo 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
3、 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 continued increase in the safe and
4、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 drafted with attention to these o
5、bjectives 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- sidered in qualifying the device
6、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 should be provided with the d
7、evice, 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 often necessitates the develo
8、pment 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 performance criteria, referee te
9、sts 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 performance per se, but rather procedu
10、res 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 device as a fume of reference fo
11、r 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, while not addressing device
12、 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 health care professionals in
13、 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 voluntary (unless, of course, th
14、ey 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 collective expertise of a commit
15、tee 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, ultimately, to help ensure pa
16、tient 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 responsible decision-making, but it
17、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 the reasons why the document
18、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, and in applying a recommen
19、ded 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 equip- ment. No single source
20、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 considerations. Similarly, a reco
21、mmended 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 provision. In summary, a standard
22、 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 interpretations of AAMI standards an
23、d 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 become official and represe
24、ntation 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 characterization or explanation of a
25、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 Instrumentation Provided by IHS und
26、er license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- American National StandardANSI/AAMI BE78:2002 (Revision of ANSI/AAMI/ISO 10993-10:1995) Biological evaluation of med
27、ical devicesPart 10: Tests for irritation and delayed-type hypersensitivity Approved 1 October 2002 by Association for the Advancement of Medical Instrumentation Approved 6 November 2002 by American National Standards Institute, Inc. Abstract:This standard describes the procedure for the assessment
28、of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. Keywords:biological evaluation, hypersensitivity, irritation, medical devices Copyright Association for the Advancement of Medical Instrumentation Provided by IH
29、S under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consens
30、us 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, processes, or procedures not conforming to the s
31、tandard. 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, or withdraw this standard no later than five ye
32、ars 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 developed by AAMI are voluntary, and their applicatio
33、n 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 for enforcement of its rules and regulations
34、. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, 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
35、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 U.S.C. 101, et seq.) to make copies of all
36、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 $100,000 per offense. For permission regarding t
37、he 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 157020179X Copyright Association for the Advancement of Medical Instrumentation Provided by IHS
38、 under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Glossary of equivalent standards.v Committee representationvii Background of ANSI/AAMI adoption of
39、 ISO 10993-10:2002 and rationale for minor technical deviation viii ANSI/AAMI deviation from ISO 10993-10:2002 viii Foreword.ix Introductionx 1Scope1 2Normative references .1 3Terms and definitions .1 4General principlesStep-wise approach2 5Pretest considerations3 5.1General3 5.2Types of material .3
40、 5.2.1Initial considerations3 5.2.2Ceramics, metals, and alloys.3 5.2.3Polymers3 5.2.4Biologically derived materials 3 5.3Information on chemical composition 3 5.3.1General3 5.3.2Existing data sources.3 5.4Material characterization4 6Irritation tests4 6.1In vitro irritation tests4 6.2Factors to be c
41、onsidered in design and selection of in vivo tests4 6.3Animal skin irritation test5 6.3.1Principle.5 6.3.2Test material5 6.3.3Animals and husbandry.5 6.3.4Test procedure.5 6.3.5Observation of animals7 6.3.6Evaluation of results 8 6.3.7Test report .8 6.4Human skin irritation test .9 6.4.1Introduction
42、9 6.4.2Initial considerations9 6.4.3Principle.9 6.4.4Description of the method9 6.4.5Data and reporting.11 7Delayed hypersensitivity tests.12 7.1Choice of test.12 7.2Choice of test sample concentrations12 7.2.1General12 7.2.2Induction12 7.2.3Challenge 13 7.3Other important factors affecting the outc
43、ome of the test13 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 02:39:16 MDTNo reproduction or networking permitted without license from IHS -,-,- 7.4Maximiz
44、ation test for delayed hypersensitivity.13 7.4.1Principle.13 7.4.2Test sample preparation13 7.4.3Animals and husbandry.13 7.4.4Test procedure.14 7.4.5Observation of animals16 7.4.6Evaluation of results 16 7.4.7Test report .16 7.5Closed-patch test for delayed hypersensitivity.16 7.5.1Principle.16 7.5
45、.2Test sample preparation16 7.5.3Animals and husbandry.16 7.5.4Test procedure.17 7.5.5Observation of animals17 7.5.6Evaluation of results 17 7.5.7Test report .18 8Key factors in interpretation of test results18 Annexes APreparation of materials for irritation/sensitization testing19 BAdditional irri
46、tation tests20 CBackground information36 Bibliography.39 Tables 1Scoring system for skin reaction.7 2Irritation response categories in rabbit8 3Human skin irritation test, grading scale.11 4Magnusson and Kligman scale.14 B.1Grading system for intracutaneous (intradermal) reactions22 B.2System for gr
47、ading ocular lesions.25 B.3Grading system for oral and penile reactions .27 B.4Grading system for microscopic examination for oral, penile, rectal, and vaginal tissue reaction29 B.5Irritation Index.29 C.1Alternative delayed contact sensitization tests .37 Figures 1Location of skin application sites
48、6 2Location of intradermal injection sites.15 B.1Arrangement of injection sites.21 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 02:39:16 MDTNo reproduction
49、or networking permitted without license from IHS -,-,- 2003 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI BE78:2002v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard