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!%h1“2691490www.din.deDIN
2、EN ISO 11138-5Sterilization of health care products Biological indicators Part 5: Biological indicators for lowtemperature steam and formaldehyde sterilization processes (ISO 111385:2017);English version EN ISO 111385:2017,English translation of DIN EN ISO 11138-5:2017-07Sterilisation von Produkten
3、fr die Gesundheitsfrsorge Biologische Indikatoren Teil 5: Biologische Indikatoren fr Sterilisationsverfahren mit NiedertemperaturDampfFormaldehyd (ISO 111385:2017);Englische Fassung EN ISO 111385:2017,Englische bersetzung von DIN EN ISO 11138-5:2017-07Strilisation des produits de sant Indicateurs bi
4、ologiques Partie 5: Indicateurs biologiques pour la strilisation la vapeur deau et au formaldhyde basse temprature (ISO 111385:2017);Version anglaise EN ISO 111385:2017,Traduction anglaise de DIN EN ISO 11138-5:2017-07SupersedesDIN EN ISO 111385:200609 andDIN EN ISO 111385Corrigendum 1:200709www.beu
5、th.deDocument comprises 16 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.07.17 DIN EN ISO 11138-5:2017-07 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11138-5:2017) has been prepared by Tec
6、hnical 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” (Secretariat: DIN, Germany), with the active participation of German experts. The responsible German body
7、involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-08 AA “Indicators”. DIN EN ISO 11138 consists of the following parts, under the general title Sterilization of health care products Biological indicators: null Part 1: General
8、requirements null Part 2: Biological indicators for ethylene oxide sterilization processes null Part 3: Biological indicators for moist heat sterilization processes null Part 4: Biological indicators for dry heat sterilization processes null Part 5: Biological indicators for low-temperature steam an
9、d formaldehyde sterilization processes The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 11138-1 DIN EN ISO 11138-1 ISO 14161 DIN EN ISO 14161 ISO 14937 DIN EN ISO 14937 ISO 25424 DIN EN ISO 25424 Amendments This standard differs from DIN
10、 EN ISO 11138-5:2006-09 and DIN EN ISO 11138-5 Corrigendum 1: 2007-09 as follows: a) in 9.6, the requirements for determining the resistance characteristics have been revised; b) the standard has been editorially revised. Previous editions DIN 58948-14: 1987-01 DIN 58948-18: 1989-10 DIN EN 866-5: 20
11、00-01 DIN EN ISO 11138-5: 2006-09 DIN EN ISO 11138-1 Corrigendum 5: 2007-09 DIN EN ISO 11138-5:2017-07 3 National Annex NA (informative) Bibliography DIN EN ISO 11138-1, Sterilization of health care products Biological indicators Part 1: General requirements DIN EN ISO 14161, Sterilization of health
12、 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 development, validation and routine control of a sterilization process f
13、or medical devices DIN EN ISO 25424, Sterilization of health care products Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11138-5:2017-07 4 This page is intentionally blank EUROPEAN STANDAR
14、D NORME EUROPENNE EUROPISCHE NORM EN ISO 11138-5 March 2017 ICS 11.080.20 Supersedes EN ISO 11138-5:2006 English Version Sterilization of health care products Biological indicators Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017) Str
15、ilisation des produits de sant Indicateurs biologiques Partie 5: Indicateurs biologiques pour la strilisation la vapeur deau et au formaldhyde basse temprature (ISO 11138-5:2017) Sterilisation von Produkten fr die Gesundheitsfrsorge Biologische Indikatoren Teil 5: Biologische Indikatoren fr Sterilis
16、ationsverfahren mit Niedertemperatur- Dampf-Formaldehyd (ISO 11138-5:2017) 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 nationa
17、l standard without any alteration. Up-to-date lists and 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 versio
18、n in any other language made by translation under the responsibility 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, Cze
19、ch 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 United Ki
20、ngdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN 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 1
21、1138-5:2017 E EN ISO 11138-5:2017 (E) 2 Contents Page European foreword . 3 Foreword 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 General requirements . 6 5 Test organism . 7 6 Suspension . 7 7 Carrier and primary packaging 7 8 Inoculated carriers and biological
22、indicators 7 9 Population and resistance . 7 Annex A (normative) Method for determination of resistance to low-temperature steam and formaldehyde . 9 Annex B (informative) Rationale for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators . 11 Bibliography .
23、12 DIN EN ISO 11138-5:2017-07 EN ISO 11138-5:2017 (E) European foreword This document (EN ISO 11138-5:2017) 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 proce
24、ssing of medical devices”, the secretariat of which 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 late
25、st by September 2017. Attention is drawn to the possibility 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 11138-5:2006. The standard is a
26、full technical revision of the previous version. The following amendments have been made in comparison with EN ISO 11138-5:2006: requirements on determination of resistance characteristics (9.6) revised. EN ISO 11138 consists of the following parts, under the general title Sterilization of health ca
27、re 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 processes Part 5: Biological indicato
28、rs 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, Cyprus, Czech Republic, Denmark
29、, 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 the United Kingdom. Endorseme
30、nt notice The text of ISO 11138-5:2017 has been approved by CEN as EN ISO 11138-5:2017 without any modification. 3 DIN EN ISO 11138-5:2017-07 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepa
31、ring 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 organizations, governmental and non-governmental, in l
32、iaison 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 its further maintenance are described in the ISO/IEC D
33、irectives, 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/ directives).Attention is drawn to the possibility t
34、hat 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 in the Introduction and/or on the ISO list of patent
35、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 ISO specific terms and expressions related to confo
36、rmity 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 Technical Committee ISO/TC 198, Sterilization of health care
37、 products.This second edition cancels and replaces the first edition (ISO 11138-5:2006), which has been technically revised.A list of all parts of ISO 11138 can be found on the ISO website.EN ISO 11138-5:2017 (E) 4 DIN EN ISO 11138-5:2017-07 IntroductionISO 11138-1 specifies production, labelling, t
38、est methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring sterilization processes. This document gives specific requirements for those biological indicators intended for use in low
39、-temperature steam and formaldehyde sterilization processes.Annex B gives rationale for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators.The ISO 11138 series represents the current “state-of-the-art” according to the experts representing manufacturers, us
40、ers 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 to provide common requirements for the production of those biological indicators that are known to be in use today.A standard exists pr
41、oviding general requirements for the validation and control of low-temperature steam and formaldehyde sterilization processes (see ISO 25424).NOTE It is possible that some countries or regions have published other standards covering requirements for sterilization or biological indicators.Advice on s
42、election, use and interpretation of results when using biological indicators can be found in ISO 14161.EN ISO 11138-5:2017 (E) 5 DIN EN ISO 11138-5:2017-07 1 ScopeThis document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intende
43、d for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.NOTE 2 Requirements f
44、or work place safety can be provided by national or regional regulations.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 unda
45、ted 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 requirements3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO
46、11138-1 and the following 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/ 3.1low-temperature steam
47、and formaldehyde sterilizationprocess incorporating forced air removal, which allows exposure of wrapped goods to steam at sub-atmospheric pressure, and thus at temperatures less than 100 C, with the admission of formaldehyde gas, keeping the sterilizing agent in a steady state throughout the hold t
48、ime4 General requirementsThe requirements of ISO 11138-1 apply.EN ISO 11138-5:2017 (E) 6 DIN EN ISO 11138-5:2017-07 5 Test organism5.1 The test organisms shall be spores of Geobacillus stearothermophilus or other strains of microorganisms of demonstrated equivalent performance as required by this do
49、cument.NOTE 1 Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus.NOTE 2 Geobacillus stearothermophilus NCIB 8224, DSM 6790, ATCC 7953, ATCC 10149 and ATCC 12980 have been found to be suitable1).5.2 If a test organism other than Geobacillus stearothermophilus is used, the suitability of the resistance of that test organism shall be determined.6 SuspensionThe require
