1、BS EN ISO 11138-3:2017Sterilization of healthcare products BiologicalindicatorsPart 3: Biological indicators for moist heatsterilization processes (ISO 11138-3:2017)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 11138-3:2017 BRITISH STANDARDNational forewo
2、rdThis British Standard is the UK implementation of EN ISO 11138-3:2017. It supersedes BS EN ISO 11138-3:2009 which iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of organizations represente
3、d on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 898
4、33 4 ICS 11.080.01 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPE
5、AN 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 indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017) Strilisation des p
6、roduits de sant - Indicateurs biologiques - Partie 3: Indicateurs biologiques pour la strilisation la chaleur humide (ISO 11138-3:2017) Sterilisation von Produkten fr die Gesundheitsfrsorge - Biologische Indikatoren - Teil 3: Biologische Indikatoren fr Sterilisationsverfahren mit feuchter Hitze (ISO
7、 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 giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibl
8、iographical 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 translation under the respon
9、sibility 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, Former Yugoslav Repu
10、blic 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 STANDARDIZATION COMIT EUROPEN
11、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 11138-3:2017 EBS EN ISO 11138-3:2017EN ISO 11138-3:2017 (E) 3
12、 European 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
13、 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 latest by September 2017. Attention is drawn to the possib
14、ility 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 f
15、ollowing 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 Directiv
16、e 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: Biolo
17、gical 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 organi
18、zations 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, M
19、alta, 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. BS EN ISO 11138-3:2017ISO 11138-3:201
20、7(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 General requirements . 15 Test organism . 16 Suspension 27 Carrier and primary packaging 28 Inoculated carriers and biological indicators 29 Population and resistance 2Annex A (normative) Method for determin
21、ation of resistance to moist heat sterilization . 4Annex B (normative) Calculation of z value and coefficient of determination, r25Bibliography 8 ISO 2017 All rights reserved iiiContents PageBS EN ISO 11138-3:2017ISO 11138-3:2017(E)ForewordISO (the International Organization for Standardization) is
22、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 for which a technical committee has been established has the right to be represent
23、ed 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) on all matters of electrotechnical standardization.The procedures used to develop t
24、his 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. This document was drafted in accordance with the editorial rules of the ISO/IEC
25、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 any or all such patent rights. Details of any patent rights identified during the
26、 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 of users and does not constitute an endorsement.For an explanation on the volunta
27、ry 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 Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.
28、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 list of all parts of ISO 11138 can be found on the ISO website.iv ISO 2017 All right
29、s reservedBS EN ISO 11138-3:2017ISO 11138-3:2017(E)IntroductionThis document 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 steriliz
30、ation 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. While air-steam mixtures can be used in moist heat sterilization p
31、rocesses, 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 representing manufacturers, users and regulatory authorities involved i
32、n 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.Standards exist providing requirements for the validation and control
33、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 interpretation of results when using biological indicators can be found i
34、n ISO 14161. ISO 2017 All rights reserved vBS EN ISO 11138-3:2017BS EN ISO 11138-3:2017Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes1 ScopeThis document specifies requirements for test organisms, suspensions, inoculat
35、ed carriers, biological indicators and test methods intended for use in assessing the performance 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
36、National 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. F
37、or 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 e
38、quipment3 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 bro
39、wsing platform: available at h t t p :/ www .iso .org/ obp4 General requirementsThe requirements 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 d
40、ocument.NOTE 1 Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus.INTERNATIONAL STANDARD ISO 11138-3:2017(E) ISO 2017 All rights reserved 1BS EN ISO 11138-3:2017ISO 11138-3:2017(E)NOTE 2 Geobacillus stearothermophilus ATCC 7953 (NCTC 10007, DSM 22 and CIP 52.81), ATC
41、C 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 shall be determined.NOTE For processes at less than 121 C, m
42、icroorganisms such as Bacillus subtilis ATCC 35021 (5230) could be used, particularly in sterilization of heat-sensitive liquids.6 SuspensionThe requirements of ISO 11138-1 apply.7 Carrier and primary packaging7.1 The suitability of the carrier and primary packaging materials for biological indicato
43、rs for use in moist heat sterilization processes shall be demonstrated in accordance with the requirements of ISO 11138-1:2017, 5.2 and Annex B.7.2 The exposure conditions to determine compliance shall bea) minimum exposure temperature: greater than or equal to 5 C above the manufacturers stated max
44、imum exposure temperature,b) sterilizing agent: dry saturated steam; if the biological indicator is intended for use in a moist heat process not using dry saturated steam, e.g. an air/steam mixture, the appropriate air steam mixture should be used and noted as an exception to this document,c) maximu
45、m exposure temperature: as stated by the manufacturer; if not stated by the manufacturer, a temperature of 140 C shall be used, andd) 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 p
46、ractical limits of a moist heat sterilization process.8 Inoculated carriers and biological indicatorsThe requirements of ISO 11138-1 apply.9 Population and resistance9.1 The manufacturer shall state the resistance characteristics in accordance with ISO 11138-1:2017, 6.4.9.2 The viable count shall be
47、 stated with increments less than or equal to 0,1 10nper unit (e.g. per ml of suspension, per inoculated carrier or per biological indicator).9.3 For inoculated carriers and biological indicators, the viable count shall be greater than or equal to 1,0 105.1) These are examples of suitable products a
48、vailable commercially. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of these products.2 ISO 2017 All rights reservedBS EN ISO 11138-3:2017ISO 11138-3:2017(E)9.4 The resistance shall be expressed as the D value in minutes at 121
49、 C. Additional temperature(s) may be selected by the manufacturer. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes to one decimal place at 121 C.9.5 Suspensions, inoculated carriers or biological indicators containing Geobacillus stearothermophilus spores shall have a D121value of greater than or equal to 1,5 min when tested according to the conditions given in Annex A. Other microorganisms shall have D values supporting the application. The z value
