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1、BRITISH STANDARD BS EN ISO 11137-2:2007 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose The European Standard EN ISO 11137-2:2007 has the status of a British Standard ICS 11.080.01 ? Licensed Copy: London South Bank University, London South Bank University
2、, Mon Jul 16 04:04:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 11137-2:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 June 2007 BSI 2007 ISBN 978 0 580 53286 3 National foreword This British Standard was published by BSI.
3、 It is the UK implementation of EN ISO 11137-2:2007. It is identical with ISO 11137-2:2006. Together with BS EN ISO 11137-1:2006 and BS EN ISO 11137-3:2006, it supersedes BS EN 552:1994 which will be withdrawn on 1 April 2009. NOTE EN 552:1994 was partially superseded by EN ISO 11137-2:2006, which w
4、as not adopted as a British Standard. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include
5、 all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank U
6、niversity, Mon Jul 16 04:04:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11137-2 May 2007 ICS 11.080.01Supersedes EN 552:1994, EN ISO 11137-2:2006 English Version Sterilization of health care products - Radiation - Part 2: Establishing the st
7、erilization dose (ISO 11137-2:2006, corrected version 2006-08-01) Strilisation des produits de sant - Irradiation - Partie 2: tablissement de la dose strilisante (ISO 11137-2:2006, version corrige 2006-08-01) Sterilisation von Produkten fr die Gesundheitsfrsorge - Strahlen - Teil 2: Festlegung der S
8、terilisationsdosis (ISO 11137-2:2006, korrigierte fassung 2006-08-01) This European Standard was approved by CEN on 12 May 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standar
9、d without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other la
10、nguage made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Fin
11、land, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES
12、KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11137-2:2007: E Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16
13、 04:04:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Foreword The text of ISO 11137-2:2006, corrected version 2006-08-01 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as
14、EN ISO 11137-2:2007 by Technical Committee CEN/TC 204 “Sterilization of medical devices“, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2007, an
15、d conflicting national standards shall be withdrawn at the latest by May 2010. This document supersedes EN 552:1994 and EN ISO 11137-2:2006 together with all parts of EN ISO 11137. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Ass
16、ociation, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound
17、to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Swit
18、zerland and United Kingdom. Endorsement notice The text of ISO 11137-2:2006, corrected version 2006-08-01 has been approved by CEN as EN ISO 11137-2:2007 without any modifications. EN ISO 11137-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:39 GMT+
19、00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 11137-2:2006(E) INTERNATIONAL STANDARD ISO 11137-2 First edition 2006-04-15 Corrected version 2006-08-01 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose Strilisation des produits de sant Irradiati
20、on Partie 2: tablissement de la dose strilisante EN ISO 11137-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:0
21、4:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Contents Page Foreword. v Introduction. vi 1 Scope 1 2 Normative references1 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 sterili
22、zation dose auditing 4 4.1 General4 4.2 Defining product families4 4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit .5 4.4 Maintaining product families6 4.5 Effect of failure of establishment of sterilization dose
23、or of a sterilization dose audit on a product family7 5 Selection and testing of 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 establis
24、hment.9 7 Method 1: dose setting using bioburden information .10 7.1 Rationale.10 7.2 Procedure for Method 1 for product with an average bioburden W W 1,0 for multiple production batches11 7.3 Procedure for Method 1 for product with an average bioburden W W 1,0 for a single production batch16 7.4 Pr
25、ocedure for Method 1 for product with an average bioburden in the range 0,1 to 0,9 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
26、.3 Procedure for Method 2B22 9 Method VDmax Substantiation of 25 kGy or 15 kGy as the sterilization dose.25 9.1 Rationale.25 9.2 Procedure for Method VDmax25 for multiple production batches.26 9.3 Procedure for Method VDmax25 for a single production batch .29 9.4 Procedure for Method VDmax15 for mul
27、tiple production batches.30 9.5 Procedure for Method VDmax15 for a single production batch .33 10 Auditing sterilization dose34 10.1 Purpose and frequency.34 EN ISO 11137-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:39 GMT+00:00 2007, Uncontrolle
28、d Copy, (c) BSI iv 10.2 Procedure for auditing a sterilization dose established using Method 1 or Method 235 10.3 Procedure for auditing a sterilization dose substantiated using VDmax.37 11 Worked examples41 11.1 Worked examples for Method 1.41 11.2 Worked examples for Method 2.44 11.3 Worked exampl
29、es for Method VDmax53 11.4 Worked example of a sterilization dose 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 wh
30、ich necessitated augmentation of the sterilization dose.56 11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax25.58 Bibliography .59 EN ISO 11137-2:2007 Annex ZA (informative) Relationship between this International Standard and the Essential .
31、61 Requirements of EU Directives 90/385/EEC of 20 June 1990 concerning active implantable medical devices, 93/42/EEC of 14 June 1993 concerning medical devices and 98/79/EC of 7 December 1988 concerning in vitro diagnostic medical devices Licensed Copy: London South Bank University, London South Ban
32、k University, Mon Jul 16 04:04:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI v Foreword 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 I
33、SO technical committees. Each member body interested in a subject for which a 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
34、closely with the International Electrotechnical Commission (IEC) on all matters 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.
35、Draft International Standards adopted by the technical committees are circulated 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 d
36、ocument may be the subject of patent rights. ISO shall not be held responsible 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
37、replaces ISO 11137:1995. ISO 11137 consists of the following parts, under the 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
38、 Part 3: Guidance on dosimetric aspects This corrected version of ISO 11137-2:2006 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,
39、 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. EN ISO 11137-2:2007 Licensed Copy: London South Bank University, London South Bank University, Mon Jul 16 04:04:39 GMT+00:00 2007, Uncontrolled Copy, (c) BSI vi Introduction This part of ISO 11137 describes methods that may
40、be used to establish the sterilization dose in accordance with one 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 bas
41、is of the dose setting methods described in this part of ISO 11137 (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
42、; Davis, Strawderman and Whitby, 1984 9) which formed the basis of 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 inactiva
43、tion of the microbial population in its natural state on product. 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 u
44、nique D10 value. In the model, the probability that an item will possess 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 D10 values of the microorganisms. The methods involve pe
45、rformance of tests of sterility on product items that have received 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 i
46、f, on performing a dose setting exercise, the derived sterilization dose for an SAL of 106 is 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 techni
47、ques demonstrated that the underlying principles were soundly based (Kowalski, Aoshuang and Tallentire, 2000) 13 and field trials confirmed that Method VDmax is effective in substantiating 25 kGy for a wide variety of medical devices manufactured and assembled in different ways (Kowalski et al., 200
48、2) 16. A standardized procedure for the use of VDmax for substantiation 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 TIR2
49、7:2001) 5, a text on which the method described herein is largely based. Method VDmax is 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 the sterilization dose. The outcomes of these tests are used to substan