1、ANSI/AAMI/ISO 14937:2009/(R)2013Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process formedical devices American National StandardObjectives and uses of AAMI standards and
2、 recommended practices It is most important that 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. Essentia
3、l to such advancement are (1) a continued increase 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 instru
4、mentation, provided that they are drafted with attention 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 perform
5、ance criteria that should be considered in qualifying 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
6、 emphasize the information that should be provided 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
7、 of performance characteristics often necessitates 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 establi
8、shment of minimum safety and performance criteria, 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 d
9、oes not address device performance per se, but rather 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 potentia
10、l purchaser or user of the device as a frame of reference 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. Al
11、so, some recommended practices, while not addressing 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; su
12、ch guidelines may be useful to health care professionals 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
13、 recommended practices are voluntary (unless, of 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 recommend
14、ed practice reflects the collective expertise of 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 res
15、pond to clinical needs and, ultimately, to help ensure 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 im
16、portant reference in responsible decision-making, 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 standard
17、s user must carefully review the reasons why the 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
18、existing devices and equipment, and in applying a 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
19、 these criteria to existing equipment. No single 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, o
20、f course, cost-benefit considerations. Similarly, 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 a
21、nd data underlying its provision. In summary, a standard 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 PRA
22、CTICES Requests for interpretations of AAMI standards 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
23、AAMI Standards Board. The interpretation will become 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
24、 disclaims responsibility for any characterization 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
25、 Standard ANSI/AAMI/ISO 14937:2009/(R)2013 (Revision of ANSI/AAMI/ISO 14937:2000) Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices Approved 2 Octob
26、er 2009 by Association for the Advancement of Medical Instrumentation Approved 27 October 2009 and reaffirmed 2 December 2013 by American National Standards Institute, Inc. Abstract: Specifies general requirements for the characterization of a sterilizing agent and for the development, validation an
27、d routine monitoring and control of a sterilization process for medical devices. Applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. Intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of prod
28、ucts to be sterilized and organizations responsible for sterilizing medical devices. Keywords: sterilization, general requirements, characterization AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with
29、 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 p
30、eriodic 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. Intereste
31、d 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 profe
32、ssional 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 Advancem
33、ent of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2009 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 rep
34、roduced or distributed in any form, including an electronic retrieval system, without the prior 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 documen
35、t (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 use of all or any part o
36、f this document, complete the reprint request form at www.aami.org or contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-369-5 Contents Page Glossary of equivalent standards .v Commit
37、tee representation vii Background of ANSI/AAMI adoption of ISO 14937:2009 ix Foreword.x Introduction .xi 1 Scope1 1.1 Inclusions 1 1.2 Exclusions .1 2 Normative references .2 3 Terms and definitions.2 4 Quality management system elements.8 4.1 Documentation 8 4.2 Management responsibility8 4.3 Produ
38、ct realization8 4.4 Measurement, analysis and improvement Control of non-conforming product .8 5 Sterilizing agent characterization8 5.1 General.8 5.2 Sterilizing agent 9 5.3 Microbicidal effectiveness .9 5.4 Effects on materials9 5.5 Safety and the environment.9 6 Process and equipment characteriza
39、tion.10 6.1 General.10 6.2 Process characterization .10 6.3 Equipment characterization.10 7 Product definition .11 8 Process definition.11 9 Validation .12 9.1 General.12 9.2 Installation qualification.13 9.3 Operational qualification13 9.4 Performance qualification14 9.5 Review and approval of vali
40、dation15 10 Routine monitoring and control 15 11 Product release from sterilization.15 12 Maintaining process effectiveness .16 12.1 General.16 12.2 Recalibration .16 12.3 Maintenance of equipment.16 12.4 Requalification 16 12.5 Assessment of change.16 Annex A (normative) Factors to be considered in
41、 selection of microorganisms for demonstrating microbicidal effectiveness.17 Annex B (normative) Approach 1 Process definition based on inactivation of the microbial population in its natural state19 Annex C (normative) Approach 2 Process definition based on inactivation of reference microorganisms
42、and knowledge of bioburden20 Annex D (normative) Approach 3 Conservative process definition based on inactivation of reference microorganisms.21 Annex E (informative) Guidance on application of this International Standard 23 Bibliography .38 Glossary of equivalent standards International Standards a
43、dopted 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 level of equivalency to the International Standard. NOTE: Documents ar
44、e sorted by international designation. 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 Equivalency IEC 60601-1:2005 Technical Corrigendum 1
45、and 2 ANSI/AAMI ES60601-1:2005 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 and 2 IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2009 ANSI/AAMI/IEC 60601-2-2:2009 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major techn
46、ical variations IEC 60601-2-19:2009 ANSI/AAMI/IEC 60601-2-19:2009 Identical IEC 60601-2-20:2009 ANSI/AAMI/IEC 60601-2-20:2009 Identical IEC 60601-2-21:2009 ANSI/AAMI/IEC 60601-2-21:2009 Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004/(R)2009 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI
47、 EC38:2007 Major technical variations IEC 60601-2-50:2009 ANSI/AAMI/IEC 60601-2-50:2009 Identical IEC 80601-2-30:2009 ANSI/AAMI/IEC 80601-2-30:2009 Identical (with inclusion) IEC 80601-2-58:2008 ANSI/AAMI/IEC 80601-2-58:2008 Identical IEC/TR 60878:2009 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62
48、296:2009 ANSI/AAMI/IEC TIR62296:2009 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006ANSI/AAMI/IEC TIR62348:2006 Identical IEC/TR 80002-1:2009 ANSI/IEC/TR 80002-1:2009 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R
49、)2004 Identical ISO 7199:2009 ANSI/AAMI/ISO 7199:2009 Identical ISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2009 ANSI/AAMI/ISO 10993-1:2009 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003/(R)2009 Identical ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002/(R)2009 and Amendment 1:2006/(R)2009 Identical ISO 10993-5:2009 ANSI/AAMI/ISO 10993-5:2009 Identical ISO 10993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical ISO 1
