1、ANSI/AAMI/ISO 10993-10: 2010/(R)2014Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitizationAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product st
2、andard 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 application of current tech
3、nologies 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
4、 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, and the measurement t
5、echniques 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 characteristic
6、s, 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 test methods to facili
7、tate 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 and the reasons for es
8、tablishing 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 tha
9、t 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. Similarly, even though
10、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, provide guidelines to
11、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 industrial practices. In deter
12、mining 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 government regulatory or pr
13、ocurement 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
14、 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 or recommended practic
15、e 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 responsible decision-makin
16、g. 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 and the specific ratio
17、nale 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 procedures and practic
18、es. 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 to identify a particul
19、ar 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 analyzed in the conte
20、xt 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 is truly useful only wh
21、en 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 must be made in writing,
22、 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 of the Association only
23、 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 recommended practice
24、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. American National Standard ANSI/AAMI/ISO 10993-10:2010/(R)2014 (Revision of ANSI/AAMI BE78:2002/(R)2008 and ANSI/AAMI BE7
25、8:2002/A1:2006/(R)2008) Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization Approved 4 September 2010 by Association for the Advancement of Medical Instrumentation Approved 10 September 2010 and Reaffirmed 8 October 2014 by American National Standards Instit
26、ute, Inc. Abstract: Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. Includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal expos
27、ure; b) details of in vivo (irritation and sensitization) test procedures, and; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are descri
28、bed for application of medical devices in areas other than skin. Keywords: biological evaluation, irritation, hypersensitivity, sensitivity, assessmentAAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned wi
29、th 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 standard. AAMI standards are subject to
30、 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 years from the date of publication. Inte
31、rested 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, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their
32、 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 for enforcement of its rules and
33、regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2010 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of IS
34、O, 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 document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, e
35、t 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 $100,000 per offen
36、se. 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, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570203954
37、 Contents PageGlossary of equivalent standards iv Committee representation .vi Background of ANSI/AAMI adoption of ISO 10993-10:2010 viii Forewordix Introduction .xi 1 Scope1 2 Normative references .1 3 Terms and definitions.2 4 General principles Step-wise approach.4 5 Pretest considerations .5 5.1
38、 General.5 5.2 Types of material.5 5.3 Information on chemical composition6 6 Irritation tests 7 6.1 In vitro irritation tests .7 6.2 In vivo irritation tests Factors to be considered in design and selection of in vivo tests7 6.3 Animal irritation test .8 6.4 Animal intracutaneous (intradermal) reac
39、tivity test12 6.5 Human skin irritation test.16 7 Skin sensitization tests 17 7.1 Choice of test methods 17 7.2 Murine Local Lymph Node Assay (LLNA) 17 7.3 Guinea pig assays for the detection of skin sensitization21 7.4 Important factors affecting the outcome of the test21 7.5 Guinea pig maximizatio
40、n test (GPMT) 22 7.6 Closed-patch test (Buehler test)26 8 Key factors in interpretation of test results .28 Annex A (normative) Preparation of materials for irritation/sensitization testing.30 Annex B (normative) Special irritation tests32 Annex C (normative) Human skin irritation test50 Annex D (in
41、formative) In vitro tests for skin irritation 54 Annex E (informative) Method for the preparation of extracts from polymeric test materials.60 Annex F (informative) Background information63 Bibliography .67 Glossary of equivalent standards International Standards adopted in the United States may inc
42、lude 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: Documents are sorted by international designati
43、on. The 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 St
44、andards 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 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 and ANSI/AAMI ES60601-1:2005/A2:2010 ANSI/AAMI ES6060
45、1-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 b) details of in vivo (irritation and sensitization) test procedures;c) key factors for the interpretation of the results.Instructions are given in Annex A for the preparation of materials specifically in relation to th
46、e above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies
47、. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1:2009, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-2, Biological evaluation of medical devices Part 2: Animal
48、welfare requirements ISO 10993-9, Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products ISO 10993-12, Biological evaluation of medical devices Part 12: Sample preparation and reference materials ISO 10993-13, Biological eva
49、luation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices ISO 10993-14 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics ISO 10993-15, Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 10993-10:2010 1 ISO 10993-18, Biological evaluation of medical devices Part 18:
