1、ANSI/AAMI/ISO 11135:2014Sterilization of health care products Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devicesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that
2、the objectives and potential uses of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increas
3、e in the safe and effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with at
4、tention to these objectives and provided that arbitrary and restrictive uses 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 considered in qualif
5、ying the device for clinical use, and the measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provide
6、d with the device, including performance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitate
7、s the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria
8、, 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 use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but ra
9、ther procedures and practices that will help ensure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of r
10、eference for device evaluation. Similarly, even though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not address
11、ing 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 useful to health care profes
12、sionals in understanding industrial practices. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of
13、course, they are adopted by government regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of
14、a committee of health care professionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help e
15、nsure patient safety. A standard or recommended practice is limited, however, in the sense 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,
16、 but it should never replace responsible decision-making. 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 user must carefully review the reasons why the
17、document was initially developed and the specific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a
18、 recommended practice to current procedures and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single
19、source of information will serve to identify a particular product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly,
20、 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 s
21、tandard or recommended practice is truly useful only when it is used 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 stand
22、ards and recommended practices must be made in writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will bec
23、ome official and representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterizatio
24、n 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 11135:2014 (Combined revi
25、sion of ANSI/AAMI/ISO 11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2007) Sterilization of health care products Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices Approved 30 March 2015 by Association for the Advancement of Medical
26、Instrumentation Approved 27 July 2015 byAmerican National Standards Institute Abstract: Specifies requirements for the development, validation, and routine control of an ethylene oxidesterilization process for medical devices. Keywords: EO, industrial sterilization, validation, routine control, medi
27、cal device, product release, processcontrol, process monitoring 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
28、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 periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE
29、: 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 five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writi
30、ng 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 user of the document. Occasionally, voluntary technical do
31、cuments 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 Advancement of Medical Instrumentation 4301 North Fairfax Drive, Suite 301 Arlington, VA 2
32、2203 2015 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 this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prio
33、r written permission of AAMI. All requests 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 f
34、or 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, contact AAMI, 4301 North Fairfax Drive, Suite 301, Arlington, VA 22203. Phone
35、: (703) 525-4890; Fax: (703) 276-0793. Printed in the United States of America ISBN 1-57020-596-5 Contents PageGlossary of equivalent standards vi Committee representation vii Background of AAMI adoption of ISO 11135-1:2007 . x Foreword . xi Introduction xii 1 Scope. 1 1.1 Inclusions 1 1.2 Exclusion
36、s 1 2 Normative references. 2 3 Terms and definitions. 3 4 Quality management systems . 11 4.1 Documentation 11 4.2 Management responsibility . 11 4.3 Product realization 11 4.4 Measurement, analysis and improvement Control of nonconforming product 11 5 Sterilizing agent characterization . 12 5.1 Ge
37、neral . 12 5.2 Sterilizing agent 12 5.3 Microbicidal effectiveness . 12 5.4 Material effects . 12 5.5 Safety and the environment 12 6 Process and equipment characterization . 12 6.1 General . 12 6.2 Process characterization 13 6.3 Equipment characterization 14 7 Product definition . 15 7.1 General .
38、 15 7.2 Product safety, quality and performance 15 7.3 Microbiological quality . 15 7.4 Documentation 16 8 Process definition 16 9 Validation . 17 9.1 General . 17 9.2 Installation qualification, IQ . 17 9.2.1 Equipment . 17 9.2.2 Installation qualification . 17 9.3 Operational qualification, OQ 18
39、9.4 Performance qualification, PQ 18 9.4.1 General 18 9.4.2 Performance qualification Microbiological . 19 9.4.3 Performance qualification Physical . 19 9.5 Review and approval of validation 20 10 Routine monitoring and control 22 11 Product release from sterilization . 24 12 Maintaining process eff
40、ectiveness . 24 12.1 General . 24 12.2 Maintenance of equipment . 24 12.3 Requalification 25 12.4 Assessment of change . 25 12.5 Assessment of equivalence 25 12.5.1 Process Equivalence . 25 12.5.2 Product 26 Annex A (normative) Determination of lethal rate of the sterilization process Biological ind
41、icator/bioburden approach 27 A.1 General . 27 A.2 Procedure . 27 Annex B (normative) Conservative determination of lethal rate of the sterilization process Overkill approach . 28 B.1 General . 28 B.2 Procedure . 28 Annex C (informative) Temperature sensors, RH sensors and biological indicator number
42、s 30 C.1 Temperature sensors 30 C.2 Humidity sensors 31 C.3 Biological Indicators 31 Annex D (informative) Guidance on the application of the normative requirements 33 D.1 Scope . 33 D.2 Normative references . 33 D.3 Terms and definitions . 33 D.4 Quality management systems 33 D.4.1 Documentation 33
43、 D.4.2 Management responsibility 33 D.4.3 Product realization . 34 D.4.4 Measurement, analysis and improvement Control of non-conforming product . 34 D.5 Sterilizing agent characterization 34 D.5.1 General 34 D.5.2 Sterilizing agent . 35 D.5.3 Microbicidal effectiveness 35 D.5.4 Material effects 35
44、D.5.5 Safety and the environment . 35 D.6 Process and equipment characterization 36 D.6.1 General 36 D.6.2 Process characterization . 36 D.6.3 Equipment characterization . 38 D.7 Product definition 40 D.7.1 General 40 D.7.2 Product safety, quality and performance . 43 D.7.3 Microbiological quality .
45、 45 D.7.4 Documentation 45 D.8 Process definition . 45 D.9 Validation 49 D.9.1 General 49 D.9.2 Installation qualification . 49 D.9.2.1 Equipment 49 D.9.2.2 Installation qualification 50 D.9.3 Operational qualification 51 D.9.4 Performance qualification 53 D.9.4.1 General. 53 D.9.4.2 Performance qua
46、lification Microbiological 54 D.9.4.3 Performance qualification Physical 55 D.9.4.4 Review and approval of validation 56 D.10 Routine monitoring and control . 57 D.11 Product release from sterilization 60 D.12 Maintaining process effectiveness 60 D.12.1 General 60 D.12.2 Maintenance of equipment 61
47、D.12.3 Requalification . 62 D.12.4 Assessment of change 64 D.12.5 Assessment of equivalence . 65 D.12.5.1 Process equivalence 65 D.12.5.2 Criteria for process equivalence . 65 D.12.5.3 Determination of process equivalence . 66 D.12.5.4 Process analysis and evaluation 66 D.12.5.5 Evaluation of precon
48、ditioning or aeration areas . 66 D.12.5.6 Evaluation of sterilization chamber performance 66 D.12.5.7 Microbiological evaluation 67 D.12.5.8 Results evaluation 67 D.12.5.9 Maintenance of equivalence . 68 D.12.5.10 Documentation . 68 D.12.5.11 Product . 68 D.12.5.11.1 Product family . 68 D.12.5.11.2
49、Determination of adverse effects to product 69 D.12.5.11.3 Determination of product design effects 69 D.12.5.11.4 Determination of product material and characteristics effects . 70 D.12.5.11.5 Determination of sterile barrier system effects 70 D.12.5.11.6 Determination of load configuration effects . 70 D.12.5.11.7 Conclusions of product adoption evaluation 70 D.13 Guidance on Annex A Determination of lethal rate of the sterilization process Biological indicator/bioburden approach . 70 D.13.1 A.1 General . 70 D.13.2 A.2 Procedure 72 D.14 Guidance
