1、ANSI/AAMI/ISO TIR13004: 2013/(R)2016Technical Information ReportSterilization of health care productsRadiation Substantiation of a selected sterilization dose: Method VDmaxSDAn ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR13004:2013 5 Sterilization of health care productsRadiation Substan
2、tiation of a selected sterilization dose: Method VDmaxSD Approved 3 September 2013 by A$0, Registered 4 October 2013 DQGUHDIILUPHG22 August 2016 by American National Standards Institute Abstract: This Technical Specification describes a method for substantiating a selected sterilization dose of17.5,
3、 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 106or less for radiation sterilization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated
4、 sterilization dose. Keywords: ISO 11137-2, Method VDmax25, Method VDmax15Published by AAMI4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org HU UH 2013 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright
5、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 pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U
6、.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. Violators risk legal action, including civil and criminal penalties, and damages of $100,0
7、00 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI at 4301 N. Fairfax Drive, Suite HU UH301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-276-0793. Printed in the United States of Am
8、erica ISBN 1-57020-504-3 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR
9、 may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents. Standards and
10、recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standards Institute. A TIR is not
11、subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or wit
12、hdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the publication date (and periodically thereafter) for guidance on whether the document is still usefulthat is, to check that the in
13、formation is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely di
14、fficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have also con
15、sidered information that may be more recent than this document. All 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
16、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. Comments on this technical information report are invited and should be s
17、ent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. ANSI Technical Report This AAMI TIR has been registered by the American National Standards Institute as an ANSI Technical Report. Publication of this ANSI Technical Report has been approved by the ac
18、credited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registration of Technical Reports with ANSI. This document is not an American National Standard and the material contained herein is not normative in natu
19、re. Comments on the content of this document should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Contents Page Glossary of equivalent standards . vii Committee representation. viii Background of AAMI adoption of ISO TS 13004:2013 xi Forewor
20、d xii Introduction xiii 1 Scope. 1 1.1 Inclusions . 1 1.2 Exclusions 1 1.3 Application 1 2 Normative references 1 3 Terms and definitions 2 4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing . 6 4.1 General 6 4.2 Defining product fa
21、milies 6 4.3 Designation of product to represent a product family . 7 4.3.1 Product to represent a product family . 7 4.3.2 Master product . 8 4.3.3 Equivalent product . 8 4.3.4 Simulated product 8 4.4 Maintaining product families 9 4.4.1 Periodic review . 9 4.4.2 Modification to product and/or manu
22、facturing process 9 4.4.3 Records . 9 4.5 Consequence of failure of sterilization dose substantiation or sterilization dose audit 9 5 Selection and testing of product for substantiating and auditing a selected sterilization dose 10 5.1 Nature of product . 10 5.2 Sample item portion (SIP) . 11 5.3 Ma
23、nner of sampling . 12 5.4 Microbiological testing 12 5.5 Irradiation 13 6 Method VDmaxSD Substantiation of a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5, or 35 kGy . 13 6.1 Rationale . 13 6.2 Procedure for Method VDmaxSDfor multiple production batches 14 6.2.1 General 14 6.2.2 Stag
24、e 1: Obtain samples of product 14 6.2.3 Stage 2: Determine average bioburden . 14 6.2.4 Stage 3: Obtain the selected sterilization dose 15 6.2.5 Stage 4: Obtain VDmaxSD. 16 6.2.6 Stage 5: Perform verification dose experiment 17 6.2.7 Stage 6: Interpretation of results 18 6.2.8 Confirmatory verificat
25、ion dose experiment. 18 6.3 Procedure for Method VDmaxSDfor a single production batch . 20 6.3.1 Rationale . 20 6.3.2 General 20 6.3.3 Stage 1: Obtain samples of product 20 6.3.4 Stage 2: Determine average bioburden . 20 6.3.5 Stage 3: Obtain the selected sterilization dose 21 6.3.6 Stage 4: Obtain
26、VDmaxSD. 21 6.3.7 Stage 5: Perform verification dose experiment 22 6.3.8 Stage 6: Interpretation of results 22 6.3.9 Confirmatory verification dose experiment. 23 7 Maintaining process effectiveness 24 7.1 General 24 7.2 Determination of bioburden 25 7.2.1 Background to frequency of determination 25
27、 7.2.2 Frequency of determination specific to Method VDmaxSD. 25 7.3 Sterilization dose audit 25 7.3.1 Frequency . 25 7.3.2 Outcome 25 7.3.3 Procedure for auditing a sterilization dose substantiated using Method VDmaxSD26 7.3.4 Failure of a sterilization dose audit 30 8 Tables of values for SIP equa
28、l to 1.0 VDmaxSD, SIP dose reduction factor and augmentation dose corresponding to applicable values of average bioburden for selected sterilization doses of 17.5, 20, 22.5, 27.5, 30, 32.5 and 35 kGy 30 9 Worked examples . 64 9.1 Substantiation of a selected sterilization dose of 17.5 kGy (SIP less
29、than 1.0) 64 9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1.0) . 66 9.3 Sterilization dose audit for a sterilization dose substantiated using Method VDmax22.5, the findings from which necessitated augmentation of the sterilization dose . 67 Bibliography 69 Tables Table
30、 1 Nature of product items for sterilization dose substantiation and for sterilization dose auditing . 10 Table 2 Examples for calculation of SIP . 11 Table 3 Upper limit of average bioburden for selection of a given sterilization dose . 16 Table 4 Table in Clause 8 corresponding to the selected ste
31、rilization dose 16 Table 5 17.5 kGy selected sterilization dose for which the upper limit of average bioburden is 9.0 . 31 Table 6 20 kGy selected sterilization dose for which the upper limit of average bioburden is 45 32 Table 7 22,5 kGy selected sterilization dose for which the upper limit of aver
32、age bioburden is 220 35 Table 8 27.5 kGy selected sterilization dose for which the upper limit of average bioburden is 5,000 . 39 Table 9 30 kGy selected sterilization dose for which the upper limit of average bioburden is 23,000 . 44 Table 10 32.5 kGy selected sterilization dose for which the upper
33、 limit of average bioburden is 100,000 . 50 Table 11 35 kGy selected sterilization dose for which the upper limit of average bioburden is 440,000 . 57 Table 12 Method VDmax17.5substantiation (SIP less than 1.0) . 65 Table 13 Method VDmax30substantiation (SIP equal to 1.0) . 66 Table 14 Sterilization
34、 dose audit following which augmentation of the sterilization dose was required (selected sterilization dose substantiated using Method VDmax22.5) . 67 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR13004:2013 vii Glossary of equivalent standards International Stand
35、ards adopted in the United States may include normative references 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. desig
36、nation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf viii 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR13004:2013 Committee representation Association for the Advancement of Medical Instrumentation Radiation Sterilizat
37、ion Working Group The adoption of ISO Technical Specification (TS) 13004, as an AAMI Technical Information Report was initiated by 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 Stan
38、dardization (ISO). U.S. representatives from the AAMI Radiation Sterilization Working Group (U.S Sub-TAG for ISO/TC 198/WG 2, Radiation Sterilization) played an active role in developing the ISO Technical Specification. At the time this document was published, the AAMI Sterilization Standards Commit
39、tee 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 Patr
40、ick McCormick, Bausch hence the documents are harmonized to a large degree. All the revisions to Method VDmax25and Method VDmax15incorporated into ISO 11137-2:2012 are also incorporated into ISO/TS 13004. AAMI TIR33:2005, Sterilization of health care products Radiation Substantiation of a sterilizat
41、ion dose: Method VDmaxwas foundational for the development of ISO/TS13004. TIR33:2005 includes the doses of the TS and also includes 25 and 15 kGy. However, it has not benefited from the revisions to Method VDmaxSDprovided in ISO 11137-2:2013, 3ndEdition and in the development of ISO/TS13004. For ex
42、ample, there are multiple clauses in Method VDmaxSDwith parallel but slightly differing requirements, e.g., multiple batch and single batch; original and confirmatory verification dose experiments; and dose auditing procedures. In the ISO revision process, these parallel sections were harmonized to
43、provide improved clarity, readability and precision of terminology. Of particular note is the harmonization of parallel sections specifying dose tolerances and interpretation of results for verification dose experiments and dose audits. A revision of TIR33 is currently planned by ST/WG2. AAMI and AN
44、SI procedures require that standards be reviewed and, if necessary, revised every five years to reflect technological advances that may have occurred since publication. AAMI (and ANSI) have adopted other ISO standards. See the Glossary of Equivalent Standards for a list of ISO standards adopted by A
45、AMI that gives the corresponding U.S. designation and the level of equivalency with the ISO standard. As used within the context of this document, “shall” indicates requirements strictly to be followed to conform to the standard. “Should” indicates that among several possibilities, one is recommende
46、d as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited. “May” is used to indicate that a course
47、of action is permissible within the limits of the standard. “Can” is used as a statement of possibility and capability. Finally, “must” is used only to describe “unavoidable” situations, including those mandated by government regulation. The concepts incorporated in this document should not be consi
48、dered inflexible or static. This standard, like any other, must be reviewed and updated periodically to assimilate progressive technological developments. To remain relevant, it must be modified as technological advances are made and as new data come to light. Suggestions for improving this document
49、 are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. NOTE Beginning with the ISO foreword on page xii, this AAMI TIR is identical to ISO/TS 13004:2013. xii 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR13004:2013 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prep
