AAMI-14160-1998.pdf
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1、American National Standard ANSI/AAMI/ISO 14160:1998 AAMI Association for the Advancement of Medical Instrumentation Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants Copyright Association
2、 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 02:24:42 MDTNo reproduction or networking permitted without license from IHS -,-,- American National StandardANSI/AAMI/ISO 141601998
3、 Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants Approved 31 July 1998 by Association for the Advancement of Medical Instrumentation Approved 10 March 2000 by American National Standard
4、s Institute, Inc. Abstract: This standard specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, of single-use medical devices comprising, in whole or in part, materials of animal origin. Keywords: calibr
5、ation, certification, manufacturing, monitoring, performance, process, qualification 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 02:24:42 MDTNo reproductio
6、n or networking permitted without license from IHS -,-,- AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclud
7、e 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 periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This
8、AAMI standard may be revised or withdrawn at any time.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 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. P
9、ublished by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-5762 1998 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 of
10、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 or
11、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 the
12、use of all or any part of this document, contact Kurt C. Larrick, Director, Technical Publishing, at AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201. Phone: (703) 525-4890, Ext. 239; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-105-6 Copyright Association for th
13、e Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:24:42 MDTNo reproduction or networking permitted without license from IHS -,-,- 1998 Association for the Advancement of Medical Instrume
14、ntation T AAMI/ISO 141601998iii Contents Page Committee representation. iv Background of AAMI adoption of ISO 14160:1998 vi Forewordvii Introduction.viii 1 Scope 1 2 Normative references 2 3 Definitions. 2 4 General. 4 5 Validation 5 6 Process control and monitoring. 8 7 Product release from sterili
15、zation. 9 Annexes A Guidance. 10 B References to European Standards with their relevant equivalents. 19 C Bibliography21 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, 0
16、3/21/2007 02:24:42 MDTNo reproduction or networking permitted without license from IHS -,-,- iv 1998 Association for the Advancement of Medical Instrumentation T AAMI/ISO 141601998 Committee representation Association for the Advancement of Medical Instrumentation Sterilization Standards Committee T
17、he adoption of ISO 14160, First edition, 1998-03-15 as an AAMI Standard was initiated by the U.S. TAG for ISO/TC 198 and the AAMI Liquid Chemical Sterilization Working Group, which also functions as the U.S. Technical Advisory Group to the relevant work in the International Organization for Standard
18、ization (ISO). U.S. representatives from the AAMI Liquid Chemical Sterilization Working Group (U.S. Sub-TAG for ISO/TC 198/WG 10, Liquid Chemical Sterilization) played an active role in developing the International Standard. The AAMI Sterilization Standards Committee has the following members: Cocha
19、irpersons:Virginia C. Chamberlain, PhD William E. Young Members:Carl W. Bruch, PhD, Consultant, Hudson, WI Virginia C. Chamberlain, PhD, Consultant, Hendersonville, NC Neal E. Danielson, Ds Enterprise Judith Dowler, Medical Devices Bureau, Health Canada, Ottawa, Canada Frank B. Engley, Jr., PhD, Uni
20、versity of Missouri, Columbia, MO Victoria Hitchins, PhD, U.S. Food and Drug Administration/Center for Devices and Radiological Health Robert Morrissey, PhD, Johnson inevitably this means that there is always a finite probability that a microorganism can survive regardless of the extent of treatment
21、 applied. For a given treatment, the probability of survival is determined by the number and types of microorganisms and by the environment in which the organisms exist during treatment. It follows that the sterility of any one item in a population of items subjected to sterilization processing cann
22、ot be guaranteed and the sterility of the processed population of items has to be defined in terms of the probability of there being a viable microorganism present on the device. Generic requirements for the quality system for the design/development, production, installation and servicing are given
23、in the ISO 9000 family of standards and in ISO 13485 and ISO 13488. The ISO 9000 series of standards designates certain processes used in manufacture as “special“ if the results cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of a special pro
24、cess because process efficacy cannot be verified by inspection and testing of the product. For this reason, sterilization processes have to be validated before use, the performance of the process monitored routinely and the equipment maintained. It is important to be aware that the exposure to a pro
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