1、ANSI/AAMI/ISO 11137-2: 2013Sterilization of health care products Radiation Part 2: Establishing the sterilization dose American National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or
2、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 increase in the safe and effective application of current technologies t
3、o 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 attention to these objectives and provided that arbitrary and restr
4、ictive 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 qualifying the device for clinical use, and the measurement techniques
5、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 provided with the device, including performance characteristics, instruc
6、tions 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 necessitates the development of specialized test methods to facilitate unifo
7、rmity 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, referee tests must be provided and the reasons for establishing
8、 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 rather procedures and practices that will help ensure that a device
9、 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 reference for device evaluation. Similarly, even though a recommen
10、ded 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 addressing device performance criteria, provide guidelines to industrial
11、 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 professionals in understanding industrial practices. In determining whe
12、ther 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 course, they are adopted by government regulatory or procurement
13、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 a committee of health care professionals and industrial represent
14、atives, 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 ensure patient safety. A standard or recommended practice is limit
15、ed, 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, but it should never replace responsible decision-making. Despite
16、 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 document was initially developed and the specific rationale for e
17、ach 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 recommended practice to current procedures and practices. While
18、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 source of information will serve to identify a particular product
19、 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, a recommended practice should be analyzed in the context of the
20、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 standard or recommended practice is truly useful only when it is u
21、sed 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 standards and recommended practices must be made in writing, to the AA
22、MI 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 become official and representation of the Association only upon exha
23、ustion 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 characterization or explanation of a standard or recommended practice which has
24、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 11137-2:2013 (Revision of ANSI/AAMI/ISO 11137-2:2012) Sterilization of health care product
25、s Radiation Part 2: Establishing the sterilization dose Approved 2 July 2013 by Association for the Advancement of Medical Instrumentation Approved 10 July 2013 by American National Standards Institute Abstract: Describes methods that can be used to determine the minimum dose necessary to achieve th
26、e specified requirement for sterility, including methods to substantiate 25 kGy as the sterilization dose. Keywords: health care products, medical equipment, sterilization, radiation, gamma, electron beam, bremsstrahlung, x-ray, dose, dose-setting AAMI Standard This Association for the Advancement o
27、f 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 preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using
28、 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 AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffi
29、rm, 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, or by visiting the AAMI website at HUwww.aami.orgUH. All AAMI standards, recommended practices, technical info
30、rmation 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 documents are adopted by government regulatory agencies or procureme
31、nt 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 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 HUwww.aami.orgUH 2013 by the Association for the Advancemen
32、t 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 prior written permission of AAMI. All requests pert
33、aining 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 for the Advancement of Medical Instrumentation.
34、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 reprint request form at HUwww.aami.orgUH or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 222
35、03-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-502-7 Contents Page Glossary of equivalent standards . v Committee representation. vi Background of ANSI/AAMI adoption of ISO 11137-2:2013 . ix Foreword x Introduction xi 1 Scope. 1 2 Normativ
36、e references 1 3 Terms, definitions and abbreviated terms 1 3.1 Terms and definitions 1 3.2 Abbreviated terms 3 4 Definition and maintenance of product families for dose setting, dose substantiation and sterilization dose auditing . 4 4.1 General 4 4.2 Defining product families 5 4.3 Designation of
37、product to represent a product family for performance of a verification dose experiment or sterilization dose audit 6 4.4 Maintaining product families 7 4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family 7 5 Selection and testing of prod
38、uct for establishing the sterilization dose . 8 5.1 Nature of product . 8 5.2 Sample item portion (SIP) . 9 5.3 Manner of sampling . 10 5.4 Microbiological testing 10 5.5 Irradiation 10 6 Methods of dose establishment . 11 7 Method 1: dose setting using bioburden information 11 7.1 Rationale . 11 7.
39、2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1.0 for multiple production batches . 12 7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1.0 for a single production batch . 18 7.4 Procedure for Method 1 for product wit
40、h an average bioburden in the range 0.1 to 0.9 for multiple or single production batches . 20 8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor 21 8.1 Rationale . 21 8.2 Procedure for Method 2A 22 8.3 Procedure for Method 2B 26
41、9 Method VDmax Substantiation of 25 kGy or 15 kGy as the sterilization dose . 29 9.1 Rationale . 29 9.2 Procedure for Method VDmax25for multiple production batches 30 9.3 Procedure for Method VDmax25for a single production batch 35 9.4 Procedure for Method VDmax15for multiple production batches 38 9
42、.5 Procedure for Method VDmax15for a single production batch 41 10 Sterilization dose audit 44 10.1 Purpose and frequency . 44 10.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A or Method 2B . 44 10.3 Procedure for auditing a sterilization dose substantiated using
43、 Method VDmax25or Method VDmax1547 10.4 Failure of a sterilization dose audit 52 11 Worked examples . 52 11.1 Worked examples for Method 1 52 11.2 Worked examples for Method 2 55 11.3 Worked examples for Method VDmax. 67 11.4 Worked example of a sterilization dose audit for a dose established using
44、Method 1, the findings from which necessitated augmentation of the sterilization dose . 69 11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the findings from which necessitated augmentation of the sterilization dose . 70 11.6 Worked example of a sterilization
45、 dose audit for a sterilization dose substantiated using Method VDmax25. 71 Bibliography 73 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11137-2:2013 v Glossary of equivalent standards International Standards adopted in the United States may include normative referen
46、ces to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard.
47、www.aami.org/standards/glossary.pdf vi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11137-2:2013 Committee representation Association for the Advancement of Medical Instrumentation Radiation Sterilization Working Group The adoption of ISO 11137-2, Third edition, as a
48、n AAMI Standard was initiated by the U.S. TAG for ISO/TC 198 and the AAMI Radiation Sterilization Working Group, which also functions as the U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Radiation St
49、erilization Working Group (U.S. Sub-TAG for ISO/TC 198/WG 2, Radiation Sterilization) played an active role in developing the International Standard. At the time this document was published, the AAMI Sterilization Standards Committee had the following members: Cochairs Victoria M. Hitchins, PhD, FDA/CDRH Michael H. Scholla, Dupont Protection Technologies Members Janet Prust , 3M Healthcare Byron Lambert , Abbott Laboratories Jeff Martin , Alcon Laboratories Inc. Ramona Conner , Association of Perioperative Registered Nurses Patrick McCormick , Bausch addition of the w
