1、American National Standard ANSI/AAMI/ISO 20857:2010/(R)2015(Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices Approved 8 December 2010 by Association for the
2、Advancement of Medical Instrumentation Approved 30 December 2010 and reaffirmed 11 December 2015 by American National Standards Institute, Inc. Abstract: Specifies requirements for the development, validation and routine control of an industrial dry heatsterilization process for medical devices. Dry
3、 heat sterilization processes covered by this standard include but are not limited to forced air cycles and convection cycles. Although this standard primarily addresses dry heat sterilization, it also covers depyrogenation processes. The standard excludes processes that utilize infrared or microwav
4、es as the heating medium. Keywords: depyrogenation, process qualification, process monitoring, thermal, parametric release, validation,routine control AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned wi
5、th 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, processes, or procedures not conforming to the standard. AAMI standards are subject to
6、 periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time.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. Interes
7、ted 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 pro
8、fessional judgment of the user 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. Published by Association for the Advanc
9、ement of Medical Instrumentation 4301 N. Fairfax Dr. Suite 301 Arlington, VA 22203-1633 www.aami.org 2011 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or an
10、y part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. 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)
11、 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 use of all or any part of this document, complete the reprin
12、t request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive Suite 301, Arlington, VA 22203-1633. Phone: +1-703- 525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1570204187 Contents PageGlossary of equivalent standards v Committee representation . vii Background
13、of US adoption of ISO 20857:2010 ix Foreword x Introduction xi 1 Scope. 1 1.1 Inclusions . 1 1.2 Exclusions 1 2 Normative references 2 3 Terms and definitions 3 4 Quality management system elements 11 4.1 Documentation . 11 4.2 Management responsibility . 11 4.3 Product realization . 11 4.4 Measurem
14、ent, analysis and improvement Control of nonconforming product . 11 5 Sterilizing agent characterization . 12 5.1 Sterilizing agent . 12 5.2 Microbicidal effectiveness 12 5.3 Material effects . 12 5.4 Environmental considerations . 12 6 Process and equipment characterization 12 6.1 Process character
15、ization 12 6.2 Equipment characterization 12 7 Product definition 15 7.1 General 15 7.2 Product safety and performance 15 7.3 Packaging considerations. 15 7.4 Microbiological quality 15 7.5 Product family 16 7.6 Biological safety . 16 8 Process definition 16 9 Validation 17 9.1 General 17 9.2 Instal
16、lation qualification 17 9.3 Operational qualification . 18 9.4 Performance qualification . 18 9.5 Additional sterilization systems . 20 9.6 Review and approval of validation . 20 10 Routine monitoring and control . 21 10.1 Routine control . 21 10.2 Routine monitoring 21 10.3 Process monitoring locat
17、ions 22 11 Product release from sterilization/depyrogenation 23 12 Maintaining process effectiveness 23 12.1 General 23 12.2 Recalibration 23 12.3 Maintenance of equipment 23 12.4 Requalification . 23 12.5 Assessment of change 24 Annex A (informative) Guidance on the application of this Internationa
18、l Standard 25 Annex B (informative) Process definition based on inactivation of the microbial population in its natural state (bioburden-based approach) 50 Annex C (informative) Process definition based on the inactivation of reference microorganisms and knowledge of bioburden (combined bioburden/bi
19、ological indicator approach) 52 Annex D (informative) Conservative process definition based on inactivation of reference microorganisms (overkill method) . 55 Annex E (informative) Process development 58 Bibliography 61 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20
20、857:2010 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and l
21、evel of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and
22、 published in 2002, was reaffirmed without change in 2009. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation EquivalencyIEC 60601-1:2005 Techn
23、ical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 and ANSI/AAMI ES60601-1:2005/A2:2010 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 inevitably this means that there is always a finite probability that a microorganism may survive regardless of the e
24、xtent of treatment applied. For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. It follows that the sterility of any one product in a population subjected to sterilizatio
25、n processing cannot be guaranteed and the sterility of a processed population is defined in terms of the probability of there being a viable microorganism present on a product. This International Standard describes requirements that, if met, will provide a dry heat sterilization process capable of s
26、terilizing medical devices through appropriate microbicidal activity. This International Standard also describes requirements that, if met, will provide a dry heat depyrogenation process through an appropriate denaturation activity. Furthermore, such compliance permits prediction, with reasonable co
27、nfidence, that there is a low probability of there being a viable microorganism present on the product after processing. Specification of this probability is a matter for regulatory authorities and may vary from country to country (see for example EN 556-1 and ANSI/AAMI ST67). Additionally, there wi
28、ll be a low probability of pyrogenic material of bacterial origin being present on the product after the application of a depyrogenation process. Generic requirements of the quality management systems for design/development, production, installation and servicing are given in ISO 9001 and particular
29、 requirements for quality management systems for medical device production in ISO 13485. The standards for quality management systems recognize that, for certain processes used in manufacturing or reprocessing, the effectiveness of the process cannot be fully verified by subsequent inspection and te
30、sting of the product. Sterilization and depyrogenation are examples of such processes. For this reason, sterilization and depyrogenation processes are validated for use, the performance of the processes is monitored routinely, and the equipment is maintained. Exposure to a properly validated, accura
31、tely controlled sterilization process is not the only factor associated with the provision of reliable assurance that the product is sterile and, in this regard, suitable for its intended use. Attention is therefore given to a number of factors including: a) the microbiological status of incoming ra
32、w materials and/or components;b) the validation and routine control of any cleaning and disinfection procedures used on the product;c) the control of the environment in which the product is manufactured, assembled and packaged;d) the control of equipment and processes;xii 2011 Association for the Ad
33、vancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010 e) the control of personnel and their hygiene;f) the manner and materials in which the product is packaged;g) the conditions under which product is stored.These factors also need consideration for the provision of reliable assurance of de
34、pyrogenation. The type of contamination on the product to be sterilized varies and this variation influences the effectiveness of a sterilization and depyrogenation process. Product that has been used in a health care setting and is being presented for resterilization in accordance with the manufact
35、urers instructions (see ISO 17664) should be regarded as a special case. There is potential for such product to possess a wide range of contaminating microorganisms and residual inorganic and/or organic contamination in spite of the application of a cleaning process. Hence, particular attention has
36、to be given to the validation and control of the cleaning and disinfection processes used during reprocessing. The requirements are the normative parts of this International Standard with which compliance is claimed. The guidance given in the informative annexes is not normative and is not provided
37、as a check list for auditors. The guidance provides explanations as well as methods that are accepted as being suitable means for complying with the requirements. Approaches other than those given in the guidance may be used if they are effective in achieving compliance with the requirements of this
38、 International Standard. The development, validation and routine control of a sterilization process and/or a depyrogenation process comprise a number of discrete but interrelated activities, for example calibration, maintenance, product definition, process definition, installation qualification, ope
39、rational qualification and performance qualification. While the activities required by this International Standard have been grouped together and are presented in a particular order, this International Standard does not require that the activities be performed in the order that they are presented. T
40、he activities required are not necessarily sequential, as the programs of development and validation might be iterative. It is possible that performing these different activities will involve a number of separate individuals and/or organizations, each of whom undertake one or more of these activitie
41、s. This International Standard does not specify the particular individuals or organizations to carry out the activities. 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010 1 American National Standard ANSI/AAMI/ISO 20857:2010/(R)2015Sterilization of health care
42、products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices 1 Scope 1.1 Inclusions 1.1.1 This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process fo
43、r medical devices. NOTE Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that might be applicable to other health care products. 1.1.2 Although this International Standard primarily addresses dry heat sterilization, it a
44、lso specifies requirements and provides guidance in relation to depyrogenation processes using dry heat. NOTE Dry heat is often used for the depyrogenation of equipment, components and health care products and its effectiveness has been demonstrated. The process parameters for sterilization and/or d
45、epyrogenation are time and temperature. Because the conditions for depyrogenation are typically more severe than those required for sterilization, a process that has been validated for product depyrogenation will result in product sterility without additional validation. 1.2 Exclusions 1.2.1 This In
46、ternational Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE See also ISO 22442-1, ISO 224
47、42-2 and ISO 22442-3. 1.2.2 This International Standard does not apply to processes that use infrared or microwaves as the heating technique. 1.2.3 This International Standard does not detail a specified requirement for designating a medical device as “sterile.“ NOTE Attention is drawn to national o
48、r regional requirements for designating medical devices as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67. 1.2.4 This International Standard does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this Inte
49、rnational Standard to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the 2 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010 sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Reg
