1、July 2017 English price group 11No 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!%guZ“2688255www.din.deDIN
2、 EN ISO 11138-3Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes (ISO 111383:2017);English version EN ISO 111383:2017,English translation of DIN EN ISO 11138-3:2017-07Sterilisation von Produkten fr die Gesundheitsfrsorge
3、Biologische Indikatoren Teil 3: Biologische Indikatoren fr Sterilisationsverfahren mit feuchter Hitze (ISO 111383:2017);Englische Fassung EN ISO 111383:2017,Englische bersetzung von DIN EN ISO 11138-3:2017-07Strilisation des produits de sant Indicateurs biologiques Partie 3: Indicateurs biologiques
4、pour la strilisation la chaleur humide (ISO 111383:2017);Version anglaise EN ISO 111383:2017,Traduction anglaise de DIN EN ISO 11138-3:2017-07SupersedesDIN EN ISO 111383:200909www.beuth.deDocument comprises 17 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original sha
5、ll be considered authoritative.06.17 DIN EN ISO 11138-3:2017-07 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11138-3:2017) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC
6、102 “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
7、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: Part 1: General requirements Part 2: Biological indicators for ethylene oxide sterilization processes Part 3: Biological indicators for mo
8、ist 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 foll
9、ows: ISO 11138-1 DIN EN ISO 11138-1 ISO 14161 DIN EN ISO 14161 ISO 17665-1 DIN EN ISO 17665-1 ISO 18472 DIN EN ISO 18472 Amendments This standard differs from DIN EN ISO 11138-3:2009-09 as follows: a) Clause 9 containing requirements for population and resistance has been revised; b) Annex A, in par
10、ticular A.2.4, step 4, has been revised; c) Annex ZA (informative) “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been deleted; d) the standard has been editorially revised. Previous editions DIN EN 866-3: 1997-05 DIN EN 866-7: 2000-01 DIN
11、EN ISO 11138-3: 2006-10, 2009-09 DIN EN ISO 11138-3:2017-07 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 care products Biological indicators Guidan
12、ce for the selection, use and interpretation of results DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 18472, Sterilization of health care products Bio
13、logical and chemical indicators Test equipment DIN EN ISO 11138-3:2017-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11138-3 March 2017 ICS 11.080.20 Supersedes EN ISO 11138-3:2009English Version Sterilization of health care products - Biological indi
14、cators -Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017) Strilisation des produits de sant - Indicateurs biologiques - Partie 3: Indicateurs biologiques pour la strilisation la chaleur humide (ISO 11138-3:2017) Sterilisation von Produkten fr die Gesundheitsfrso
15、rge - Biologische Indikatoren - Teil 3: Biologische Indikatoren fr Sterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2017) 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
16、 giving this European Standard the status of a national 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
17、 official versions (English, French, German). A version 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 bodi
18、es of Austria, Belgium, Bulgaria, 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, Slov
19、enia, Spain, Sweden, Switzerland, Turkey and United Kingdom. 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
20、 worldwide for CEN national Members. Ref. No. EN ISO 11138-3:2017 EEuropean foreword . 3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 General requirements . 65 Test organism . 66 Suspension 77 Carrier and primary packaging 78 Inoculated carriers and biological indicat
21、ors 79 Population and resistance 7Annex A (normative) Method for determination of resistance to moist heat sterilization . 9Annex B (normative) Calculation of z value and coefficient of determination, r2. 10Bibliography . 13Contents PageDIN EN ISO 11138-3:2017-07 EN ISO 11138-3:2017 (E) 2Foreword 4E
22、uropean foreword This document (EN ISO 11138-3:2017) 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 h
23、eld 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 possibil
24、ity 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 11138-3:2009. The standard is a full technical revision of the previous version. The fol
25、lowing amendments have been made in comparison with EN ISO 11138-3:2009: requirements on population and resistance (clause 9) revised; Annex A, in particular A.2.4 step 4 revised; informative Annex ZA respective relationship between this European Standard and the essential requirements of Directive
26、93/42/EEC OJ L 169 aimed to be covered was deleted. 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: Biologi
27、cal indicators for moist heat sterilization processes Part 4: Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes According to the CEN-CENELEC Internal Regulations, the national standards organiza
28、tions of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Mal
29、ta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11138-3:2017 has been approved by CEN as EN ISO 11138-3:2017 without any modification. DIN EN ISO 11138-3:2017-07 EN ISO 11138
30、-3:2017 (E) 3 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 subject
31、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 (IEC) o
32、n 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 be noted
33、. 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 identifying
34、 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 convenience
35、 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 Technical
36、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 11138-3:2006), which has been technically revised.A li
37、st of all parts of ISO 11138 can be found on the ISO website.DIN EN ISO 11138-3:2017-07 EN ISO 11138-3:2017 (E) 4 IntroductionThis document specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspen
38、sions intended for use in validation and monitoring of sterilization processes. This document gives specific requirements for those biological indicators intended for use in moist heat sterilization processes.Moist heat as the sterilizing agent is defined in this document as dry saturated steam. Whi
39、le air-steam mixtures can be used in moist heat sterilization processes, the methods and performance requirements of this document might not be applicable for biological indicators used in such processes.The ISO 11138 series represents the current “state-of-the-art” according to the experts represen
40、ting 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 to provide common requirements for the production of those biological indicators known to be in use today.Standar
41、ds exist providing requirements for the validation and control of moist heat sterilization (see ISO 17665 series).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 interpreta
42、tion of results when using biological indicators can be found in ISO 14161.DIN EN ISO 11138-3:2017-07 EN ISO 11138-3:2017 (E) 5 1 ScopeThis document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the p
43、erformance of sterilization processes employing moist heat as the sterilizing agent.NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.NOTE 2 National or regional regulations can provide requirements for work place safety.2 Norma
44、tive 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 undated references, the latest edition of the referenced document (including any ame
45、ndments) 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 equipment3 Terms and definitionsFor the purposes of this document, the terms and definit
46、ions 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 :/ www .iso .org/ obp4 General requirementsThe req
47、uirements of ISO 11138-1 apply.5 Test organism5.1 The test organisms shall be spores of Geobacillus stearothermophilus or other strains of microorganism of demonstrated equivalent performance as required by this document.NOTE 1 Bacillus stearothermophilus has been reclassified as Geobacillus stearot
48、hermophilus.DIN EN ISO 11138-3:2017-07 EN ISO 11138-3:2017 (E) 6 NOTE 2 Geobacillus stearothermophilus ATCC 7953 (NCTC 10007, DSM 22 and CIP 52.81), ATCC 12980 (equivalent to NRRL B-4419) have been found to be suitable1)12.5.2 If a test organism other than Geobacillus stearothermophilus or Bacillus subtilis ATCC 35021 (5230) is used, the suitability of the resistance of that test organism s
