1、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!%gu“2688256www.din.deDIN EN ISO 111
2、38-4Sterilization of health care products Biological indicators Part 4: Biological indicators for dry heat sterilization processes (ISO 111384:2017);English version EN ISO 111384:2017,English translation of DIN EN ISO 11138-4:2017-07Sterilisation von Produkten fr die Gesundheitsfrsorge Biologische I
3、ndikatoren Teil 4: Biologische Indikatoren fr Sterilisationsverfahren mit trockener Hitze (ISO 111384:2017);Englische Fassung EN ISO 111384:2017,Englische bersetzung von DIN EN ISO 11138-4:2017-07Strilisation des produits de sant Indicateurs biologiques Partie 4: Indicateurs biologiques pour la stri
4、lisation la chaleur sche (ISO 111384:2017);Version anglaise EN ISO 111384:2017,Traduction anglaise de DIN EN ISO 11138-4:2017-07SupersedesDIN EN ISO 111384:200609www.beuth.deDocument comprises 17 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be consider
5、ed authoritative.July 201706.17 DIN EN ISO 11138-4:2017-07 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11138-4:2017) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “
6、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 063-0
7、4-08 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 requirements null Part 2: Biological indicators for ethylene oxide sterilization processes null Part 3: Biological indicat
8、ors for moist heat sterilization processes null Part 4: Biological indicators for dry heat sterilization processes null Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes The DIN Standards corresponding to the International Standards referred to in this
9、document are as follows: ISO 11138-1 DIN EN ISO 11138-1 ISO 14161 DIN EN ISO 14161 ISO 18472 DIN EN ISO 18472 ISO 20857 DIN EN ISO 20857 Amendments This standard differs from DIN EN ISO 11138-4:2006-09 as follows: a) in 9.6, the requirements for determining the resistance characteristics have been r
10、evised; b) the standard has been editorially revised. Previous editions DIN 58947-4: 1987-06, 1990-11 DIN EN 866-6: 2000-01 DIN EN ISO 11138-4: 2006-09 DIN EN ISO 11138-4:2017-07 3 National Annex NA (informative) Bibliography DIN EN ISO 11138-1, Sterilization of health care products Biological indic
11、ators Part 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 18472, Sterilization of health care products Biological and chemical indicators Test equipment DIN EN ISO 20857, S
12、terilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11138-4:2017-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11138-4 March 2017 ICS
13、11.080.20 Supersedes EN ISO 11138-4:2006 English Version Sterilization of health care products Biological indicators Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017) Strilisation des produits de sant Indicateurs biologiques Partie 4: Indicateurs biologiques pour
14、la strilisation la chaleur sche (ISO 11138-4:2017) Sterilisation von Produkten fr die Gesundheitsfrsorge Biologische Indikatoren Teil 4: Biologische Indikatoren fr Sterilisationsverfahren mit trockener Hitze(ISO 11138-4:2017) This European Standard was approved by CEN on 19 January 2017. CEN members
15、 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 national standards may be obtained on application
16、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 language and notified to the CEN-CENELEC Management
17、 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, Hungary, Iceland, Ireland, Italy, Latvia, Lit
18、huania, 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 NORMUNG CEN-CENELEC Management Centre: Avenue Mar
19、nix 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 11138-4:2017 E EN ISO 11138-4:2017 (E) 2 Contents Page European foreword . 3 Foreword 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and
20、definitions . 6 4 General requirements . 6 5 Test organism . 6 6 Suspension . 7 7 Carrier and primary packaging 7 8 Inoculated carriers and biological indicators 7 9 Population and resistance . 7 Annex A (normative) Method for determination of resistance to dry heat sterilization . 9 Annex B (normat
21、ive) Calculation of z value . 10 Bibliography . 13 DIN EN ISO 11138-4:2017-07 European foreword This document (EN ISO 11138-4:2017) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products in collaboration with Technical Committee CEN/TC 102 “Sterilizers and associa
22、ted equipment 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 b
23、e withdrawn 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 11138-4:2
24、006. The standard is a full technical revision of the previous version. The following amendments have been made in comparison with EN ISO 11138-4:2006: requirements on determination of resistance characteristics (9.6) revised. EN ISO 11138 consists of the following parts, under the general title Ste
25、rilization 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 processes Part
26、 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, Cyprus,
27、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 the Un
28、ited Kingdom. Endorsement notice The text of ISO 11138-4:2017 has been approved by CEN as EN ISO 11138-4:2017 without any modification. EN ISO 11138-4:2017 (E) 3 DIN EN ISO 11138-4:2017-07 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standard
29、s 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 organiz
30、ations, 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 fur
31、ther 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/ dire
32、ctives).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
33、 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
34、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 Technical Com
35、mittee ISO/TC 198, Sterilization of health care products.This second edition cancels and replaces the first edition (ISO 11138-4:2006), which has been technically revised.A list of all the parts of ISO 11138 can be found on the ISO website.EN ISO 11138-4:2017 (E) 4 DIN EN ISO 11138-4:2017-07 Introdu
36、ctionISO 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 sterilization processes. This document gives specific requirements for
37、those biological indicators intended for use in dry heat 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 promote the
38、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 providing general requirements for the validation and control of dry heat sterilization processeses (se
39、e ISO 20857).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.EN ISO 11138-4:2017 (E) 5
40、DIN EN ISO 11138-4:2017-07 1 ScopeThis document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temp
41、eratures within the range of 120 C to 180 C.NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.NOTE 2 Requirements for work place safety can be provided by national or regional regulations.2 Normative referencesThe following documents are ref
42、erred 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 amendments) applies.ISO 11138-1:2017, Sterilizati
43、on 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 definitions given in ISO 11138-1 apply.ISO and IEC ma
44、intain 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 requirementsThe requirements of ISO 11138-1 apply.5 Test orga
45、nism5.1 The test organisms shall be spores of Bacillus atrophaeus or other strains of microorganisms of demonstrated equivalent performance as required by this document.NOTE 1 Some strains of Bacillus subtilis have been reclassified as Bacillus atrophaeus.EN ISO 11138-4:2017 (E) 6 DIN EN ISO 11138-4
46、:2017-07 NOTE 2 Bacillus atrophaeus CIP 77.18, NCIMB 8058, DSM 675, NRRL B-4418 and ATCC 9372 or Bacillus subtilis, DSM 13019 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
47、SuspensionThe requirements of ISO 11138-1 apply.7 Carrier and primary packaging7.1 The suitability of the carrier and primary packaging materials for biological indicators for use in dry heat sterilization processes shall be demonstrated in accordance with the requirements of ISO 11138-1:2017, 5.2 a
48、nd Annex B.7.2 The exposure conditions to determine compliance shall be the following:a) minimum exposure temperature: greater than or equal to 5 C above the manufacturers stated maximum temperature;b) sterilizing agent: dry heat in ambient air;c) maximum exposure temperature: as stated by the manuf
49、acturer; if not stated by the manufacturer, the maximum exposure temperature shall be greater than or equal to 180 C;d) exposure time: greater than or equal to 30 min.NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of a dry heat sterilization process.8 Inoculated carriers and biological indicatorsThe requirements of
