ANSI AAMI 11137-2-2013 Sterilization of health care products - Radiation - Part 2 Establishing the sterilization dose.pdf

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

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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

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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

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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

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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