1、BS EN ISO 11138-2:2017Sterilization of health care products Biological indicatorsPart 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 11138-2:2017 BRITISH STANDARDNational
2、 forewordThis British Standard is the UK implementation of EN ISO 11138-2:2017. It supersedes BS EN ISO 11138-2:2009 which iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of organizations rep
3、resented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0
4、580 89832 7 ICS 11.080.01 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e
5、dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11138-2 March 2017 ICS 11.080.20 Supersedes EN ISO 11138-2:2009English Version Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017) Strilis
6、ation des produits de sant - Indicateurs biologiques - Partie 2: Indicateurs biologiques pour la strilisation loxyde dthylne (ISO 11138-2:2017)Sterilisation von Produkten fr die Gesundheitsfrsorge - Biologische Indikatoren - Teil 2: Biologische Indikatoren fr Sterilisationsverfahren mit Ethylenoxid
7、(ISO 11138-2:2017) This European Standard was approved by CEN on 19 January 2017. 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 standard without any alteration. Up-to-date lists and
8、bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the re
9、sponsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav
10、Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EURO
11、PEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11138-2:2017 EBS EN ISO 11138-2:2017EN ISO 11138-2:2017 (
12、E) 3 European foreword This document (EN ISO 11138-2:2017) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products in collaboration with Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of whic
13、h is held by DIN. 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 September 2017 and conflicting national standards shall be withdrawn at the latest by September 2017. Attention is drawn to the po
14、ssibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11138-2:2009. The standard is a full technical revision of the previous version. T
15、he following amendments have been made in comparison with EN ISO 11138-2:2009: requirements on population and resistance (clause 9) revised, e.g. information to minimum D-value at 30 C deleted; Annex A, in particular A.2.4 step 6 revised; informative Annex B on rationale for the inclusion of a secon
16、d D-value and deletion of the requirement for a minimum D-value at 30 C added; informative Annex ZA respective relationship between this European Standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered was deleted. EN ISO 11138 consists of the following parts, und
17、er the general title Sterilization of health care products Biological indicators: Part 1: General requirements Part 2: Biological indicators for ethylene oxide sterilization processes Part 3: Biological indicators for moist heat sterilization processes Part 4: Biological indicators for dry heat ster
18、ilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bul
19、garia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switze
20、rland, Turkey and the United Kingdom. BS EN ISO 11138-2:2017EN ISO 11138-2:2017 (E) 4 Endorsement notice The text of ISO 11138-2:2017 has been approved by CEN as EN ISO 11138-2:2017 without any modification. BS EN ISO 11138-2:2017ISO 11138-2:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative ref
21、erences 13 Terms and definitions . 14 General requirements . 15 Test organism . 16 Suspension 27 Carrier and primary packaging 28 Inoculated carriers and biological indicators 29 Population and resistance 2Annex A (normative) Method for determination of resistance to ethylene oxide sterilization 4An
22、nex B (informative) Rationale for the inclusion of a second minimum D value specification as a result of changes to the test gas used to evaluate resistance and deletion of the requirement for a minimum D value at 30 C 5Bibliography 6 ISO 2017 All rights reserved iiiContents PageBS EN ISO 11138-2:20
23、17ISO 11138-2:2017(E)ForewordISO (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 s
24、ubject 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 closely with the International Electrotechnical Commission
25、(IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should b
26、e noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).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 for iden
27、tifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the conv
28、enience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Tec
29、hnical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.This third edition cancels and replaces the second edition (ISO 11138-2:2006), which has been technically revis
30、ed.A list of all parts of ISO 11138 can be found on the ISO website.iv ISO 2017 All rights reservedBS EN ISO 11138-2:2017ISO 11138-2:2017(E)IntroductionISO 11138-1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators including inocul
31、ated carriers and suspensions intended for use in validation and monitoring of sterilization processes. This document gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes.The ISO 11138 series represents the current “state-of-the-art”
32、according to the experts representing manufacturers, users and regulatory authorities involved in developing the standard. The intent is not to promote the use of biological indicators where such use is not advised, but rather to provide common requirements for the production of those biological ind
33、icators that are known to be in use today.Standards exist providing requirements for the validation and control of ethylene oxide sterilization (see ISO 11135 and ISO 14937).NOTE It is possible that some countries or regions have published other standards covering requirements for sterilization or b
34、iological indicators.Advice on selection, use and interpretation of results when using biological indicators can be found in ISO 14161. ISO 2017 All rights reserved vBS EN ISO 11138-2:2017BS EN ISO 11138-2:2017Sterilization of health care products Biological indicators Part 2: Biological indicators
35、for ethylene oxide sterilization processes1 ScopeThis document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as
36、the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 C to 65 C.NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.NOTE 2 Na
37、tional or regional regulations can provide requirements for work place safety.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For
38、 undated references, the latest edition of the referenced document (including any amendments) applies.ISO 11138-1:2017, Sterilization of health care products Biological indicators Part 1: General requirementsISO 18472, Sterilization of health care products Biological and chemical indicators Test equ
39、ipment3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 11138-1 apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online brows
40、ing platform: available at h t t p s :/ www .iso .org/ obp/ 4 General requirementsThe requirements of ISO 11138-1 apply.5 Test organism5.1 The test organisms shall be spores of Bacillus atrophaeus, Bacillus subtilis or other strains of microorganisms of demonstrated equivalent performance as require
41、d by this document.NOTE 1 Some strains of Bacillus subtilis have been reclassified as Bacillus atrophaeus.INTERNATIONAL STANDARD ISO 11138-2:2017(E) ISO 2017 All rights reserved 1BS EN ISO 11138-2:2017ISO 11138-2:2017(E)NOTE 2 Bacillus atrophaeus ATCC 9372, NCTC 10073, NCIMB 8058, DSM 2277, NRRL B-4
42、418 and CIP 77.18 have been found to be suitable1).5.2 If a test organism other than Bacillus atrophaeus is used, the suitability of the resistance of that test organism shall be determined.6 SuspensionThe requirements of ISO 11138-1 apply.7 Carrier and primary packaging7.1 The suitability of the ca
43、rrier and primary packaging materials for biological indicators for use in ethylene oxide sterilization processes shall be demonstrated in accordance with the requirements of ISO 11138-1:2017, 5.2 and Annex B.7.2 The exposure conditions to determine compliance shall bea) minimum exposure temperature
44、: greater than or equal to 55 C,b) sterilizing agent: ethylene oxide gas at a concentration not less than 800 mg/l in air at greater thanor equal to 70 % RH,c) maximum exposure temperature: as stated by the biological indicator manufacturer, andd) exposure time: greater than or equal to 6h.NOTE Thes
45、e conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of an ethylene oxide sterilization process.8 Inoculated carriers and biological indicatorsThe requirements of ISO 11138-1 apply.9 Population and resistance9.1 The manufacture
46、r shall state the resistance characteristics in accordance with ISO 11138-1:2017, 6.4.9.2 The viable count shall be stated with increments less than or equal to 0,1 10nper unit (e.g. per ml of suspension, per inoculated carrier or per biological indicator).9.3 For inoculated carriers and biological
47、indicators, the viable count shall be greater than or equal to 1,0 106.9.4 The resistance shall be expressed as the D value in minutes, at 54 C. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes, to one decimal place at 54 C.9.5 Suspensions, ino
48、culated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D value of not less than 2,5 min at 54 C when tested according to the conditions in Annex A using test gas mixtures (see Annex B). Other microorganisms shall have D values supporting the application.1) These
49、 are examples of suitable products available commercially. This information is given for the convenienceof users of this document and does not constitute an endorsement by ISO of these products.2 ISO 2017 All rights reservedBS EN ISO 11138-2:2017ISO 11138-2:2017(E)9.6 Suspensions, inoculated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D value of not less than 2,0 min at 54 C when tested according to the conditions in Annex A using a test gas consisting of 10
