AAMI-TIR14969-2004.pdf
《AAMI-TIR14969-2004.pdf》由会员分享,可在线阅读,更多相关《AAMI-TIR14969-2004.pdf(90页珍藏版)》请在三一文库上搜索。
1、 Technical Information Report ANSI/AAMI/ISO TIR14969:2004 Medical devicesQuality management systems Guidance on the application of ISO 13485:2003 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing,
2、 Bernie Not for Resale, 03/21/2007 02:53:30 MDTNo reproduction or networking permitted without license from IHS -,-,- An ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR14969:2004 (Revision of ANSI/AAMI/ISO 14969:1999) Medical devicesQuality management systems Guidance on the application of
3、ISO 13485:2003 Approved 15 July 2004 by Association for the Advancement of Medical Instrumentation Registered on 15 August 2004 by American National Standards Institute, Inc. Abstract: Provides guidance on the application of requirements contained in ISO 13485:2003, including detailed guidance relat
4、ed to process validation, design control, and quality planning. Keywords: medical devices, quality management systems, design control, process control, quality records Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/
5、1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:53:30 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 2004 by the Association for the A
6、dvancement 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 system, without the prior written permission of AAMI. All requ
7、ests pertaining to this document 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 the Association for the Advancement of Medical Instrume
8、ntation. 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 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067.
9、Printed in the United States of America ISBN 1570202214 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 02:53:30 MDTNo reproduction or networking permitted wit
10、hout license from IHS -,-,- AAMI Technical Information 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
11、TIR may need further evaluation by experts, releasing 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 a
12、nd recommended practices are subject to a formal 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 n
13、ot subject to the same formal approval process 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
14、withdrawnand the action formally approved usually 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
15、 information is relevant or of historical value. 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
16、 difficult or unlikely. Unlike a standard, a 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
17、considered information that may be more recent 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
18、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. Comments on this technical information report are invited and should b
19、e sent to AAMI, Attn: Standards Department, 1110 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 ac
20、credited standards developer (AAMI). This document 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. C
21、opyright 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 02:53:30 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Glossary of equ
22、ivalent standardsvi Committee representation. viii Background of AAMI adoption of ISO/TR14969:2004x Foreword.xi Introduction xii 1 Scope1 1.1 General 1 1.2 Application1 1.2.1 General2 1.2.2 Exclusions2 1.2.3 Non-applicability.2 2 Normative references2 3 Terms and definitions2 4 Quality management sy
23、stem.3 4.1 General requirements 3 4.2 Documentation requirements.4 4.2.1 General4 4.2.2 Quality manual.6 4.2.3 Control of documents.6 4.2.4 Control of records 8 5 Management responsibility .9 5.1 Management commitment9 5.2 Customer focus10 5.3 Quality policy10 5.4 Planning.11 5.4.1 Quality objective
24、s.11 5.4.2 Quality management system planning.12 5.5 Responsibility, authority, and communication.13 5.5.1 Responsibility and authority.13 5.5.2 Management representative 13 5.5.3 Internal communication14 5.6 Management review.14 5.6.1 General14 5.6.2 Review input 15 5.6.3 Review output16 6 Resource
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- AAMI TIR14969 2004
链接地址:https://www.31doc.com/p-3728637.html