SANS 11137-2-2007 Sterilization of health care products - Radiation Part 2 Establishing the sterilization dose《保健品消毒 辐射 第2部分 确定消毒使用剂量》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-19691-2 SANS 11137-2:2007Edition 1 ISO 11137-2:2006Edition 1SOUTH AFRICAN NATIONAL STANDARD Sterilization of health care products Radiatio

4、n Part 2: Establishing the sterilization dose This national standard is the identical implementation of ISO 11137-2:2006 and is adopted with the permission of the International Organization for Standardization. Published by Standards South Africa 1 dr lategan road groenkloof private bag x191 pretori

5、a 0001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 11137-2:2007 Edition 1 ISO 11137-2:2006 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee StanSA SC 5140.

6、37D, Medical devices Sterilization of healthcare products, in accordance with procedures of Standards South Africa, in compliance with annex 3 of the WTO/TBT agreement. This part of SANS 11137 was published in May 2007. This SANS document supersedes SANS 11137:2006 (edition 1, ISO tech. corr. 1, and

7、 ISO amdt 1) in part. Reference numberISO 11137-2:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11137-2First edition2006-04-15Corrected version2006-08-01Sterilization of health care products Radiation Part 2: Establishing the sterilization dose Strilisation des produits de sant Irradiation Partie 2: tabl

8、issement de la dose strilisante SANS 11137-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-2:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be pri

9、nted or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no l

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11、s suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or

12、by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-

13、mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reservedSANS 11137-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-2:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword. v Intro

14、duction . vi 1 Scope 1 2 Normative references 1 3 Abbreviations, terms and definitions 1 3.1 Abbreviations.1 3.2 Terms 3 4 Definition and maintenance of product families for dose setting, dose substantiation and sterilization dose auditing 4 4.1 General4 4.2 Defining product families4 4.3 Designatio

15、n of product to represent a product family for performance of a verification dose experiment or sterilization dose audit .5 4.4 Maintaining product families 6 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 o

16、f product for establishing and verifying the sterilization dose .7 5.1 Nature of product.7 5.2 Sample item portion (SIP) .8 5.3 Manner of sampling.8 5.4 Microbiological testing9 5.5 Irradiation .9 6 Methods of dose establishment.9 7 Method 1: dose setting using bioburden information .10 7.1 Rational

17、e.10 7.2 Procedure for Method 1 for product with an average bioburden W 1,0 for multiple production batches11 7.3 Procedure for Method 1 for product with an average bioburden W 1,0 for a single production batch16 7.4 Procedure for Method 1 for product with an average bioburden in the range 0,1 to 0,

18、9 for multiple or single production batches.18 8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor18 8.1 Rationale.18 8.2 Procedure for Method 2A19 8.3 Procedure for Method 2B22 9 Method VDmax Substantiation of 25 kGy or 15 kGy as

19、 the sterilization dose.25 9.1 Rationale.25 9.2 Procedure for Method VDmax25for multiple production batches .26 9.3 Procedure for Method VDmax25for a single production batch .29 9.4 Procedure for Method VDmax15for multiple production batches .30 9.5 Procedure for Method VDmax15for a single productio

20、n batch .33 10 Auditing sterilization dose34 10.1 Purpose and frequency.34 SANS 11137-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-2:2006(E) iv ISO 2006 All rights reserved10.2 Procedure for auditing a sterilization dose es

21、tablished using Method 1 or Method 2 35 10.3 Procedure for auditing a sterilization dose substantiated using VDmax. 37 11 Worked examples 41 11.1 Worked examples for Method 1. 41 11.2 Worked examples for Method 2. 44 11.3 Worked examples for Method VDmax53 11.4 Worked example of a sterilization dose

22、 audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose. 55 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. 56 11.6

23、 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25. 58 Bibliography . 59 SANS 11137-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-2:2006(E) ISO 2006 All rights reserved

24、vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a

25、technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matter

26、s of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulat

27、ed to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible

28、 for identifying any or all such patent rights. ISO 11137-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This first edition, together with ISO 11137-1 and ISO 11137-3, cancels and replaces ISO 11137:1995. ISO 11137 consists of the following parts, under the

29、general title Sterilization of health care products Radiation: Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices Part 2: Establishing the sterilization dose Part 3: Guidance on dosimetric aspects This corrected version of ISO 11137-2:

30、2006 incorporates changes in the following subclauses: 4.3.1.3, 5.1.1, 7.1, 7.2.3.2, 7.3.4.2, 7.4, 8.1, 8.2.3.1.1, 8.2.3.3.1, 8.2.6.3, 8.3.3.3.1, 8.3.6.3, 9.2.3.2, 9.2.4, 9.3.4.2, 9.3.5, 9.3.6.2, 9.4.1.2, 9.4.3.2, 9.4.5.2, 9.5.2.2, 9.5.4.2, 9.5.6.2, 10.2.5.2, 10.2.6.1, 10.3.3.2, 10.3.6.4.2, 11.3. SA

31、NS 11137-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-2:2006(E) vi ISO 2006 All rights reservedIntroduction This part of ISO 11137 describes methods that may be used to establish the sterilization dose in accordance with on

32、e of the two approaches specified in 8.2 of ISO 11137-1:2006. The methods used in these approaches are: a) dose setting to obtain a product-specific dose; b) dose substantiation to verify a preselected dose of 25 kGy or 15 kGy. The basis of the dose setting methods described in this part of ISO 1113

33、7 (Methods 1 and 2) owe much to the ideas first propounded by Tallentire (Tallentire, 1973 17; Tallentire, Dwyer and Ley, 1971 18; Tallentire and Khan, 1978 19). Subsequently, standardized protocols were developed (Davis et al., 1981 8; Davis, Strawderman and Whitby, 1984 9) which formed the basis o

34、f the dose setting methods detailed in the AAMI Recommended Practice for Sterilization by Gamma Radiation (AAMI 1984, 1991 4, 6). Methods 1 and 2 and the associated sterilization dose audit procedures use data derived from the inactivation of the microbial population in its natural state on product.

35、 The methods are based on a probability model for the inactivation of microbial populations. The probability model, as applied to bioburden made up of a mixture of various microbial species, assumes that each such species has its own unique D10value. In the model, the probability that an item will p

36、ossess a surviving microorganism after exposure to a given dose of radiation is defined in terms of the initial number of microorganisms on the item prior to irradiation and the D10values of the microorganisms. The methods involve performance of tests of sterility on product items that have received

37、 doses of radiation lower than the sterilization dose. The outcome of these tests is used to predict the dose needed to achieve a predetermined sterility assurance level, SAL. Methods 1 and 2 may also be used to substantiate 25 kGy if, on performing a dose setting exercise, the derived sterilization

38、 dose for an SAL of 106is u 25 kGy. The basis of the method devised specifically for substantiation of 25 kGy, Method VDmax, was put forward by Kowalski and Tallentire (1999) 14. Subsequent evaluations involving computational techniques demonstrated that the underlying principles were soundly based

39、(Kowalski, Aoshuang and Tallentire, 2000) 13and field trials confirmed that Method VDmaxis effective in substantiating 25 kGy for a wide variety of medical devices manufactured and assembled in different ways (Kowalski et al., 2002) 16. A standardized procedure for the use of VDmaxfor substantiation

40、 of a sterilization dose of 25 kGy has been published in the AAMI Technical Information Report Sterilization of health care products Radiation sterilization Substantiation of 25 kGy as a sterilization dose Method VDmax(AAMI TIR27:2001) 5, a text on which the method described herein is largely based.

41、 Method VDmaxis founded on dose setting Method 1 and, as such, it possesses the high level of conservativeness characteristic of Method 1. In a similar manner to the dose setting methods, it involves performance of tests of sterility on product items that have received a dose of radiation lower than

42、 the sterilization dose. The outcomes of these tests are used to substantiate that 25 kGy achieves an SAL of 106. To link the use of VDmaxfor the substantiation of a particular preselected sterilization dose, the numerical value of the latter, expressed in kGy, is included as a superscript to the VD

43、maxsymbol. Thus, for substantiation of a sterilization dose of 25 kGy the method is designated VDmax25. Method VDmax15is based on the same principles as Method VDmax25described above. The test procedure is the same as Method VDmax25, but VDmax15is limited to product with average bioburden u 1,5. The

44、 outcomes of these tests are used to substantiate that 15 kGy achieves a sterility assurance level of 106. This part of ISO 11137 also describes methods that may be used to carry out sterilization dose audits in accordance with ISO 11137-1:2006, Clause 12. Following establishment of the sterilizatio

45、n dose, sterilization dose audits are performed routinely to confirm that the sterilization dose continues to achieve the desired SAL. SANS 11137-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 11137-2:2006(E)

46、 ISO 2006 All rights reserved 1Sterilization of health care products Radiation Part 2: Establishing the sterilization dose 1 Scope This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 2

47、5 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 106. This part of ISO 11137 also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establ

48、ishment and dose auditing. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

49、 ISO 11137-1:2006, Sterilization of health care products Radiation Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination of the population of microorganisms on product ISO 11737-2, Sterilization of medical devices Microbiological methods Part 2: Test of sterility performed in the validation of a sterilization process ISO 13485, Med