AAMI-TIR10993-20-2006.pdf
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1、ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices Technical Information Report Technical Information Report Association for the Advancement of Medical Instrumentation Copyright Association for the A
2、dvancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:56:41 MDTNo reproduction or networking permitted without license from IHS -,-,- An ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR
3、10993-20:2006 Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices Approved 5 September 2005 by Association for the Advancement of Medical Instrumentation Approved 16 October 2005 by American National Standards Institute, Inc. Abstr
4、act: Covers current state of knowledge in the area of immunotoxicology, including information on methods of assessment and their predictive value; to identify what the problems are and how they have been dealt with in the past; and offers advice on how the problems should be addressed in future stan
5、dards. Keywords: immunotoxicology, immunosuppression, immunostimulation, hypersensitivity, chronic inflammation, autoimmunity Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resa
6、le, 03/21/2007 02:56:41 MDTNo reproduction or networking permitted without license from IHS -,-,- Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2006 by the Association for the Advancement of Medical Instrumentation All
7、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 of AAMI. All requests pertaining to this draft should be su
8、bmitted 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 Medical Instrumentation. Violators risk legal action, includi
9、ng 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: (703) 525-1067. Printed in the United States of America ISBN
10、1570202680 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 02:56:41 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Technical In
11、formation Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, r
12、eleasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents. Standards and recommended practices are subject to a for
13、mal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standards Institute. A TIR is not subject to the same formal approval proces
14、s as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usu
15、ally every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the publication date (and periodically thereafter) for guidance on whether the document is still usefulthat is, to check that the information is relevant or of historical val
16、ue. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a
17、TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have also considered information that may be more recen
18、t than this document. All 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 tech
19、nical 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. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 1
20、110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. ANSI Technical Report This AAMI TIR has been registered by the American National Standards Institute as an ANSI Technical Report. Publication of this ANSI Technical Report has been approved by the accredited standards developer (AAMI). This doc
21、ument is registered as a Technical Report series of publications according to the Procedures for the Registration of ANSI Technical Reports. This document is not an American National Standard and the material contained herein is not normative in nature. Copyright Association for the Advancement of M
22、edical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:56:41 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Glossary of equivalent standards v Committee representation.
23、 vii Background of AAMI adoption of ISO/TS 10993-20. viii Foreword. x Introduction xii 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Risk assessment and risk management. 2 5 Identification of hazards. 3 6 Methods of assessment of immunotoxicity. 5 6.1 General. 5 6.2 Inflammation
24、6 6.3 Immunosuppression. 6 6.4 Immunostimulation. 8 6.5 Hypersensitivity 8 6.6 Auto-immunity. 8 7 Extrapolation of data provided by pre-clinical assays 8 Annex A (informative) Current state of knowledge.10 Annex B (informative) Clinical experience with medical devices14 Annex C (informative) Flow ch
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