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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8、AAMI standard may be revised or withdrawn at any time.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
25、perly validated and accurately controlled sterilization process is not the only factor associated with the provision of reliable assurance that the product is sterile and in this respect suitable for its intended use. Attention has also to be given to a number of factors, including the microbiologic
26、al status (bioburden) of incoming raw materials and/or components, their subsequent storage, and to the control of the environment in which the product is manufactured, assembled and packaged. The agents for sterilization used most frequently for medical devices are moist heat, dry heat, irradiation
27、 and ethylene oxide. While some devices containing animal tissues may be compatible with these commonly applied methods of sterilization (for example catgut sutures are usually sterilized by irradiation), other devices, such as biological heart valves or tissue patches, are not compatible with conve
28、ntional sterilization processes. It has been recognized that other sterilizing agents might have to be used in these exceptional circumstances. Liquid chemical sterilants have been widely used in such instances and, in common with the other sterilization methods, the efficacy of the process needs to
29、 be demonstrated and recorded before it is adopted for routine use. This International Standard contains requirements for the validation and routine monitoring of sterilization of single-use medical devices containing materials of animal origin by exposure to liquid chemical sterilants; guidance on
30、the application of this International Standard is given in annex A. Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can in themselves reduce significantly the bioburden on the medical device. Following the manufacturing proce
31、ss, a medical device is exposed to a defined sterilization process; the requirements for validation and routine control described in this International Standard apply only to this defined sterilization process and do not take account of the lethal effects of other bioburden reduction steps. NOTE The
32、 guidance given in annex A is not obligatory and it is not provided as a check list for auditors. 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 MDTN
33、o reproduction or networking permitted without license from IHS -,-,- 1998 Association for the Advancement of Medical Instrumentation T AAMI/ISO 1416019981 AAMI Standard AAMI/ISO 141601998 Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine con
34、trol of sterilization by liquid chemical sterilants 1 Scope This International 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
35、, materials of animal origin. This International Standard does not apply to material of human origin. This International Standard does not describe a quality assurance system for the control of all stages of manufacture. NOTE 1 Attention is drawn to the standards for quality systems (see ISO 9001 an
36、d ISO 13485 or ISO 9002 and ISO 13488) which can be used in the control of all stages of manufacture including the sterilization process. This International Standard does not describe tests to establish the effects of any chosen sterilization method upon the fitness for use of the medical device. NO
37、TE 2 Such testing is a crucial part of the design and development of a medical device. This International Standard does not describe methods for the validation of the inactivation of viruses. NOTE 3 In developing a method for processing medical devices containing materials of animal origin, consider
38、ation of the effects of liquid chemical sterilization on potential viral contaminants will also be necessary because of the source of materials used in the manufacture of these particular medical devices. The importance of validation of viral inactivation for processes within the scope of this Inter
39、national Standard is recognized. This aspect is excluded from this International Standard; a separate European Standard is in preparation (EN 12442-3). NOTE 4 Liquid chemical sterilants traditionally employed to sterilize animal tissues in medical devices may not be effective in inactivating the cau
40、sative agents of transmissible spongiform encephalopathies such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this International Standard should not be assumed to demonstrate inactivation of infective agents of this type. This International Standar
41、d does not cover the level of residual sterilant within medical devices. NOTE 5 ISO 14538 is concerned with this issue. 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
42、/21/2007 02:24:42 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 1998 Association for the Advancement of Medical Instrumentation T AAMI/ISO 141601998 2 Normative references The following standards contain provisions, which, through reference in this text, constitute prov
43、isions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated b
44、elow. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 9001:1994, Quality systems Model for quality assurance in design, development, production, installation and servicing. ISO 9002:1994, Quality systems Model for quality assurance in production, and install
45、ation and servicing. ISO 11138-1:1994, Sterilization of health care products Biological indicators Part 1: General. ISO 11737-1:1995, Sterilization of health care products Microbiological methods Part 1: Estimation of the population of microorganisms on product. NOTE The relationship between Interna
46、tional Standards and European Standards is given in annex B. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 batch defined quantity of bulk, intermediate, or finished product that is intended or purported to be uniform in character and quality, and
47、 which has been produced during a defined cycle of manufacture 3.2 bioburden population of viable microorganisms on a product and/or a package 3.3 carrier supporting material on which test organisms are deposited 3.4 commissioning obtaining and documenting evidence that equipment has been provided a
48、nd installed in accordance with its specifications and that it functions within predetermined limits when operated in accordance with operational instructions 3.5 decimal reduction value D-value time (expressed in minutes) or irradiation dose (expressed in kilograys) required to achieve inactivation of 90% of a population of the test organism under stated exposure conditions 3.6 exposure time time for which the medical device is exposed at the specified temperature and sterilant concentration Copyright Association for the Advancement of Medical I