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American National Standard
ANSI/AAMI/ISO 10993-3:2003
AAMI
Association for the
Advancement of Medical Instrumentation
Biological evaluation of medical devices—
Part 3: Tests for genotoxicity,
carcinogenicity, and reproductive toxicity
The Objectives and Us of AAMI Standards and Recommended Practices
It is most important that the objectives and potential us of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMI's technical development program derive from AAMI's overall mission: the advancement of medical instrumentation. Esntial to 固态相变
such advancement are (1) a continued increa in the safe and effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMI's view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to the objectives and provided that arbitrary and restrictive us 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 u, and the measurement techniques that can be ud 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, including performance characteristics, instructions for u, warnings and precautions, and other data considered important in ensuring the safe and effective u of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching connsus on the tests can reprent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of mini
mum safety and performance 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 u, care, and/or processing of a medical device or system. A recommended practice does not address device performance per , but rather procedures and practices that will help ensure that a device is ud 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 purchar or ur of the device as a fume of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards health care professionals, it may be uful to the manufacturer in better understanding the environment in which a medical device will be ud. Also, some recommended practices, 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 uful to 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 ur of the document, veral important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of cour, 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 ur of the document.
Each AAMI standard or recommended practice reflects the collective experti of a committee of health care professionals and industrial reprentatives, who work has been reviewed nationally (and sometimes internationally). As such, the connsus 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 practice is limited, however, in the n 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 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 ur must carefully review the reasons why the document was initially developed and the specific rat
ionale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the ur.
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 practices. While obrved or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be ud in applying the criteria to existing equip-ment. No single source of information will rve to identify a particular product as "unsafe". A voluntary standard can be ud as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of cour, cost-benefit considerations. 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 provision.
In summary, a standard or recommended practice is truly uful only when it is ud 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, to the Manager for Technical Development. An official interpretation must be approved by letter ballot of the originating committee and subquently reviewed and approved by the AAMI Standards Board. The interpretation will become official and reprentation of the Association only upon exhaustion of any appeals and upon publication of notice of interpre-tation in the "Standards Monitor" ction 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 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 10993-3:2003
(Revision of ANSI/AAMI/ISO 10993-3:1993) Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and
reproductive toxicity Approved 8 October 2003by
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Association for the Advancement of Medical Instrumentation
Approved 23 October 2003 by
American National Standards Institute, Inc.
Abstract:Specifies strategies for hazard identification and tests on medical devices for genotoxicity, carcinogenicity, and reproductive and developmental toxicity.
Keywords:biological evaluation, genotoxicity, carcinogenicity, medical devices, reproductive and developmental toxicity
AAMI Standard
This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a connsus of tho 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, process, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and urs are cautioned to obtain the latest editions.
CAUTION NOTICE: This AAMI standard may be revid or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revi, 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 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 ur of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which ca 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 Association for the Advancement of Medical Instrumentation
All Rights Rerved
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 submitted to AAMI. It is illegal under federal law (17 U.S.C. § 101, et q.) 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. For permission regarding the u 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
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ISBN 1–57020–207–9
Contents
Glossary of equivalent standards (iv)
Committee reprentation (vi)
Background of ANSI/AAMI adoption of ISO 10993-3:2003 (vii)
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Foreword (viii)
Introduction (ix)
自我鉴定护理专业1 Scope (1)
2 Normative references (1)
3 Terms and definitions (2)
4 Genotoxicity tests (2)
4.1 General (2)
strategy (2)
4.2 Test
preparation (3)
4.3 Sample乌克兰男女比例
4.4 Test以爱为题的作文
methods (3)
5 Carcinogenicity tests (4)
5.1 General (4)
strategy (4)
5.2 Test
preparation (4)
5.3 Sample
methods (4)
5.4 Test
6 Reproductive and developmental toxicity tests (5)
6.1 General (5)
strategy (5)
6.2 Test
preparation (5)
6.3 Sample
methods (5)
6.4 Test
7 Test report (6)
Annex A (informative) Cell transformation test system (7)
Annex B (informative) Rationale of test systems (8)
Annex C (informative) Role of implantation carcinogenicity studies (9)
Bibliography (11)
