1、July 2017 English price group 19No 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!%guW“2688252www.din.deDIN
2、 EN ISO 11138-1Sterilization of health care products Biological indicators Part 1: General requirements (ISO 111381:2017);English version EN ISO 111381:2017,English translation of DIN EN ISO 11138-1:2017-07Sterilisation von Produkten fr die Gesundheitsfrsorge Biologische Indikatoren Teil 1: Allgemei
3、ne Anforderungen (ISO 111381:2017);Englische Fassung EN ISO 111381:2017,Englische bersetzung von DIN EN ISO 11138-1:2017-07Strilisation des produits de sant Indicateurs biologiques Partie 1: Exigences gnrales (ISO 111381:2017);Version anglaise EN ISO 111381:2017,Traduction anglaise de DIN EN ISO 111
4、38-1:2017-07SupersedesDIN EN ISO 111381:200609 andDIN EN ISO 111381Corrigendum 1:200808www.beuth.deDocument comprises 51 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.06.17 DIN EN ISO 11138-1:2017-07 2 A comma is used as the
5、decimal marker. National foreword This document (EN ISO 11138-1:2017) 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” (Secretariat
6、: 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 063-04-08 AA “Indicators”. DIN EN ISO 11138 consists of the following parts, under the ge
7、neral 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 sterilization
8、 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 follows: ISO 8601 DIN ISO 8601 ISO 11135 DIN EN ISO 11135 ISO 11140-1 DIN EN ISO 11140-1 ISO
9、11737-1:2006 DIN EN ISO 11737-1:2009-09 ISO 13485 DIN EN ISO 13485 ISO 14161:2009 DIN EN ISO 14161:2010-03 ISO 14937 DIN EN ISO 14937 ISO 15223-1 DIN EN ISO 15223-1 ISO 17665-1 DIN EN ISO 17665-1 ISO 18472 DIN EN ISO 18472 ISO 80000 DIN EN ISO 80000 (all parts) IEC 60027 (all parts) DIN EN 60027 (al
10、l parts) Amendments This standard differs from DIN EN ISO 11138-1:2006-09 and DIN EN ISO 11138-1 Corrigendum 1:2008-08 as follows: a) normative references have been updated; b) the terms “FBIO-value” and “packaging system” have been deleted; c) in Clause 4, general manufacturing requirements includi
11、ng Table 1 have been revised; e.g. requirements on traceability have been added; DIN EN ISO 11138-1:2017-07 3 d) in 5.2, requirements on carrier and the primary and secondary packaging have been revised; e) the reference to ISO 11607 regarding the type of packaging of biological indicators has been
12、deleted; f) in 6.1.2 and 6.4.3, general resistance requirements have been revised; g) in 7.4 and 7.5, requirements for software validation and detection systems have been added; h) in Annex B, for determination of growth inhibition by carriers and primary packaging materials exposed to sterilization
13、 processes, the number of probes has been increased and requirements have been revised; i) the standard has been editorially revised. Previous editions DIN EN 866-1: 1997-05 DIN EN ISO 11138-1: 2006-09 DIN EN ISO 11138-1 Corrigendum 1: 2008-08 DIN EN ISO 11138-1:2017-07 4 National Annex NA (informat
14、ive) Bibliography DIN EN 60027 (all parts), Letter symbols to be used in electrical technology 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 11140-1, St
15、erilization of health care products Chemical indicators Part 1: General requirements DIN EN ISO 11737-1:2009-09, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) DIN EN ISO 13485, Medical devices Quality m
16、anagement systems Requirements for regulatory purposes DIN EN ISO 14161:2010-03, Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results (ISO 14161:2009) DIN EN ISO 14937, Sterilization of health care products General requirements for
17、 characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN
18、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 Biological and chemical indicators Test equipment DIN EN ISO 80000
19、 (all parts), Quantities and units DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11138-1 March 2017 ICS 11.080.20 Supersedes EN ISO 11138-1:2006English Version Sterilization of he
20、alth care products - Biological indicators -Part 1: General requirements (ISO 11138-1:2017) Strilisation des produits de sant - Indicateurs biologiques - Partie 1: Exigences gnrales(ISO 11138-1:2017) Sterilisation von Produkten fr die Gesundheitsfrsorge - Biologische Indikatoren - Teil 1: Allgemeine
21、 Anforderungen (ISO 11138-1:2017) 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-
22、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 version in any other language made by translati
23、on 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, Czech Republic, Denmark, Estonia, Finland, F
24、ormer 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 Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZA
25、TION 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 11138-1:2017 EEuropean foreword .3Introduc
26、tion 61 Scope . 72 Normative references 73 Terms and definitions . 74 General manufacturing requirements 104.1 Manufacturing controls 104.1.1 Quality management systems 104.1.2 Traceability 104.1.3 Finished product requirements . 104.1.4 Personnel . 104.2 Test organism 104.2.1 Strain . 104.2.2 Origi
27、nating inoculum for suspension 114.2.3 Test organism count . 114.3 Information to be provided by the manufacturer (labelling) 114.4 Storage and transport 125 Specific manufacturing requirements 135.1 Suspensions 135.2 Carrier, primary and secondary packaging . 135.3 Inoculated carrier 135.4 Biologic
28、al indicators 145.5 Self-contained biological indicators 146 Determination of population and resistance . 146.1 General resistance requirements . 146.2 Test organism 146.3 Population of test organisms . 146.4 Resistance characteristics 156.5 Test conditions . 157 Culture conditions167.1 Incubator .
29、167.2 Growth medium 167.3 Incubation 167.4 Software validation 177.5 Incubation time using detection system 17Annex A (normative) Determination of viable count .18Annex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes .20
30、Annex C (normative) D value determination by survivor curve method .23Annex D (normative) D value determination by fraction negative method 27Annex E (normative) Survival-kill response characteristics 43Annex F (informative) Relationship between components of biological indicators45Bibliography .46C
31、ontents PageDIN EN ISO 11138-1:2017-07 EN ISO 11138-1:2017 (E)2Foreword 5European foreword This document (EN ISO 11138-1:2017) 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 e
32、quipment for processing 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 wit
33、hdrawn at the latest 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 11138-1:2006.
34、The standard is a full technical revision of the previous version. The following amendments have been made in comparison with EN ISO 11138-1:2006: Normative references and bibliography updated; Terms and definitions FBIO-value“ und packaging system“ deleted; General manufacturing requirements (claus
35、e 4) including Table 1 revised, e.g. requirements on traceability added; requirements on carrier and the primary and secondary packaging revised; general resistance requirements (6.1.2 and 6.4.3) revised; requirements on software validation (7.4) and detection systems (7.5) added; for determination
36、of growth inhibition by carriers and primary packaging materials exposed to sterilization processes the number of probes was increased and requirements revised (see Annex B). EN ISO 11138 consists of the following parts, under the general title Sterilization of health care products Biological indica
37、tors: 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 indicators for low-temperature steam
38、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, Estonia, Finland, Former Yu
39、goslav Republic of Macedonia, DIN EN ISO 11138-1:2017-07 EN ISO 11138-1:2017 (E)3 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 Un
40、ited Kingdom. Endorsement notice The text of ISO 11138-1:2017 has been approved by CEN as EN ISO 11138-1:2017 without any modification. DIN EN ISO 11138-1:2017-07 EN ISO 11138-1:2017 (E)4 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards
41、 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 organiza
42、tions, 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 its furt
43、her 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/ direc
44、tives).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 in the
45、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 ISO s
46、pecific 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 Technical Comm
47、ittee ISO/TC 198, Sterilization of health care products.This third edition cancels and replaces the second edition (ISO 11138-1:2006), which has been technically revised.A list of all parts of ISO 11138 can be found on the ISO website.DIN EN ISO 11138-1:2017-07 EN ISO 11138-1:2017 (E)5 IntroductionT
48、his document specifies general requirements for 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. Other parts of ISO 11138 provide additional specific requirements for biological indicators for defined sterilization processes.A graphic description of a biological indicator and its c
