1、July 2017 English price group 10No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.080.20!%guY“2688254www.din.deDIN
2、 EN ISO 11138-2Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 111382:2017);English version EN ISO 111382:2017,English translation of DIN EN ISO 11138-2:2017-07Sterilisation von Produkten fr die Gesundheitsfrso
3、rge Biologische Indikatoren Teil 2: Biologische Indikatoren fr Sterilisationsverfahren mit Ethylenoxid (ISO 111382:2017);Englische Fassung EN ISO 111382:2017,Englische bersetzung von DIN EN ISO 11138-2:2017-07Strilisation des produits de sant Indicateurs biologiques Partie 2: Indicateurs biologiques
4、 pour la strilisation loxyde dthylne (ISO 111382:2017);Version anglaise EN ISO 111382:2017,Traduction anglaise de DIN EN ISO 11138-2:2017-07SupersedesDIN EN ISO 111382:200909www.beuth.deDocument comprises 15 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall
5、 be considered authoritative.06.17 DIN EN ISO 11138-2:2017-07 2 A comma is used as the decimal marker. National 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 10
6、2 “Sterilizers and associated equipment for processing of medical devices” (Secretariat: DIN, Germany), with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 06
7、3-04-08 AA “Indicators”. DIN EN ISO 11138 consists of the following parts, under 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 mois
8、t heat sterilization processes Part 4: Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes The DIN Standards corresponding to the International Standards referred to in this document are as follow
9、s: ISO 11135 DIN EN ISO 11135 ISO 11138-1 DIN EN ISO 11138-1 ISO 14161 DIN EN ISO 14161 ISO 14937 DIN EN ISO 14937 ISO 18472 DIN EN ISO 14872 Amendments This standard differs from DIN EN ISO 11138-2:2009-09 as follows: a) in Clause 9, requirements on population and resistance have been revised, e.g.
10、 information on minimum D-value at 30 C has been deleted; b) Annex A, in particular A.2.4, step 6, has been revised; c) informative Annex B on rationale for the inclusion of a second D-value and deletion of the requirement for a minimum D-value at 30 C has been added; d) Annex ZA (informative) “Rela
11、tionship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been deleted; e) the standard has been editorially revised. Previous editions DIN EN 886-2: 1997-05 DIN EN 886-8: 2000-02 DIN EN ISO 11138-2: 2006-10, 2009-09 DIN EN ISO 11138-2:2017-07 3 National A
12、nnex NA (informative) Bibliography DIN EN ISO 11135, Sterilization of health care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11138-1, Sterilization of health care products Biological indicators Pa
13、rt 1: General requirements DIN EN ISO 14161, Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results DIN EN ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the deve
14、lopment, validation and routine control of a sterilization process for medical devices DIN EN ISO 18472, Sterilization of health care products Biological and chemical indicators Test equipment DIN EN ISO 11138-2:2017-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE
15、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) Strilisation des produits de sant - Indicateurs biolog
16、iques - 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 (ISO 11138-2:2017) This European Standard was a
17、pproved 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 bibliographical references concerning such nati
18、onal 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 responsibility of a CEN member into its own langu
19、age 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 Republic of Macedonia, France, Germany, Greece,
20、 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 EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NOR
21、MUNG 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 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitio
22、ns . 64 General requirements . 65 Test organism . 66 Suspension 77 Carrier and primary packaging 78 Inoculated carriers and biological indicators 79 Population and resistance 7Annex A (normative) Method for determination of resistance to ethylene oxide sterilization 9Annex B (informative) Rationale
23、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 . 10Bibliography . 11Contents PageForeword .4DIN EN ISO 11138-2:2017-07 EN ISO 11138-2:2017 (E) 2 European fore
24、word 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 which is held by DIN.
25、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 possibility that som
26、e 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. The following amend
27、ments 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 second D-value and dele
28、tion 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, under the general tit
29、le 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 sterilization processe
30、s 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, Bulgaria, Croatia, Cy
31、prus, 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, Switzerland, Turkey and
32、the United Kingdom. Endorsement notice The text of ISO 11138-2:2017 has been approved by CEN as EN ISO 11138-2:2017 without any modification. DIN EN ISO 11138-2:2017-07 EN ISO 11138-2:2017 (E)3 ForewordISO (the International Organization for Standardization) is a worldwide federation of national sta
33、ndards 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 technical committee has been established has the right to be represented on that committee. International or
34、ganizations, 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 matters of electrotechnical standardization.The procedures used to develop this document and those intended for it
35、s 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 be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/
36、 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 identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be i
37、n 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 convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of
38、 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 Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technica
39、l 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 revised.A list of all parts of ISO 11138 can be found on the ISO website.DIN EN ISO 11138-2:2017-07 EN ISO 11138-2:2017 (E) 4 Introd
40、uctionISO 11138-1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. This document gives specific requirements
41、for those biological indicators intended for use in ethylene oxide sterilization processes.The ISO 11138 series represents the current “state-of-the-art” according to the experts representing manufacturers, users and regulatory authorities involved in developing the standard. The intent is not to pr
42、omote the use of biological indicators where such use is not advised, but rather to provide common requirements for the production of those biological indicators that are known to be in use today.Standards exist providing requirements for the validation and control of ethylene oxide sterilization (s
43、ee ISO 11135 and ISO 14937).NOTE It is possible that some countries or regions have published other standards covering requirements for sterilization or biological indicators.Advice on selection, use and interpretation of results when using biological indicators can be found in ISO 14161.DIN EN ISO
44、11138-2:2017-07 EN ISO 11138-2:2017 (E)5 1 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 t
45、he 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 Nat
46、ional 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
47、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 equi
48、pment3 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 browsing platform: available at h t t p s :/ www .iso .org/ obp/ 4 General require
