1、BS EN ISO 11138-1:2017Sterilization of health care products Biological indicatorsPart 1: General requirements (ISO 11138-1:2017)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 11138-1:2017 BRITISH STANDARDNational forewordThis British Standard is the UK imp
2、lementation of EN ISO 11138-1:2017. It supersedes BS EN ISO 11138-1:2006 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 represented on this committee can be obtained o
3、n 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 89831 0 ICS 11.080.20; 11.080.01 Complia
4、nce 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 dEUROPEAN STANDARD NORME EUROPENN
5、E EUROPISCHE NORM EN ISO 11138-1 March 2017 ICS 11.080.20 Supersedes EN ISO 11138-1:2006English Version Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017) Strilisation des produits de sant - Indicateurs biologiques - Partie 1: Exigences gn
6、rales (ISO 11138-1:2017) Sterilisation von Produkten fr die Gesundheitsfrsorge - Biologische Indikatoren - Teil 1: Allgemeine 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 whic
7、h 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 to the CEN-CENELEC Management Centre or to any CEN member. This Eur
8、opean 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 Centre has the same status as the official versions. CEN members a
9、re 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, R
10、omania, 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 Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any
11、form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11138-1:2017 EBS EN ISO 11138-1:2017EN ISO 11138-1:2017 (E) 3 European foreword This document (EN ISO 11138-1:2017) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products in collabo
12、ration with Technical Committee CEN/TC 102 “Sterilizers and associated 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
13、latest by September 2017 and conflicting national standards shall be 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 o
14、r all such patent rights. This document supersedes EN ISO 11138-1:2006. 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“
15、und packaging system“ deleted; General manufacturing requirements (clause 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 softwar
16、e validation (7.4) and detection systems (7.5) added; for determination 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 t
17、he 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 moist heat sterilization processes Part 4: Biological indicators for dry heat steriliz
18、ation processes Part 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, Bulgari
19、a, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, BS EN ISO 11138-1:2017EN ISO 11138-1:2017 (E) 4 France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbi
20、a, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11138-1:2017 has been approved by CEN as EN ISO 11138-1:2017 without any modification. BS EN ISO 11138-1:2017ISO 11138-1:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative referen
21、ces 13 Terms and definitions . 14 General manufacturing requirements . 44.1 Manufacturing controls . 44.1.1 Quality management systems . 44.1.2 Traceability . 44.1.3 Finished product requirements 44.1.4 Personnel 44.2 Test organism . 44.2.1 Strain 44.2.2 Originating inoculum for suspension. 54.2.3 T
22、est organism count 54.3 Information to be provided by the manufacturer (labelling) . 54.4 Storage and transport . 65 Specific manufacturing requirements . 75.1 Suspensions . 75.2 Carrier, primary and secondary packaging 75.3 Inoculated carrier . 75.4 Biological indicators . 85.5 Self-contained biolo
23、gical indicators . 86 Determination of population and resistance 86.1 General resistance requirements 86.2 Test organism . 86.3 Population of test organisms 86.4 Resistance characteristics . 96.5 Test conditions 97 Culture conditions107.1 Incubator . 107.2 Growth medium 107.3 Incubation 107.4 Softwa
24、re validation 117.5 Incubation time using detection system 11Annex A (normative) Determination of viable count .12Annex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes .14Annex C (normative) D value determination by surv
25、ivor curve method .17Annex D (normative) D value determination by fraction negative method 21Annex E (normative) Survival-kill response characteristics 37Annex F (informative) Relationship between components of biological indicators39Bibliography .40 ISO 2017 All rights reserved iiiContents PageBS E
26、N ISO 11138-1:2017ISO 11138-1:2017(E)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 i
27、nterested 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 liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechn
28、ical 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 Directives, Part 1. In particular the different approval criteria needed for the different types of ISO do
29、cuments 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 that some of the elements of this document may be the subject of patent rights. ISO shall not be held resp
30、onsible 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 declarations received (see www .iso .org/ patents).Any trade name used in this document is information gi
31、ven 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 conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) princ
32、iples 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 products.This third edition cancels and replaces the second edition (ISO 11138-1:2006), which has been t
33、echnically revised.A list of all parts of ISO 11138 can be found on the ISO website.iv ISO 2017 All rights reservedBS EN ISO 11138-1:2017ISO 11138-1:2017(E)IntroductionThis document specifies general requirements for production, labelling, test methods and performance requirements for the manufactur
34、e 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
35、a biological indicator and its components is presented in Table F.1. The presentation includes the two types of biological indicators which are covered by ISO 11138 (all parts). This shows that inoculated carriers can be presented directly to the sterilizing agent without prior packaging, or include
36、d in a primary package that permits access by the sterilizing agent.The resistance characteristics depend on the type of test organism, its numbers, the method of preparation, the substrate upon which it is inoculated, environmental conditions during inoculation and drying and the effects of the pri
37、mary package. Advice on selection, use and interpretation of results of biological indicators can be found in ISO 14161.For any individual sterilization process, including those covered in relevant parts of ISO 11138, the resistance of the biological indicator will also depend on its microenvironmen
38、t during testing. In theory, this could lead to an infinite variation in the preparation of biological indicators. Moreover, a sterilization process could be manipulated in infinite variety to suit each possible set of conditions to which products could be exposed. It has, therefore, been a routine
39、practice to manufacture biological indicators that, when exposed to a set of conditions in a defined sterilization process, provide resistance characteristics expressed as D values and, where relevant, z values. Such values are set out in the relevant parts of ISO 11138.The ISO 11138 series represen
40、ts the current “state-of-the-art” according to the experts representing manufacturers, users and regulatory authorities involved in developing this document.Biological indicators for specific sterilization processes not covered by reference test conditions in relevant parts of ISO 11138 should compl
41、y with the general requirements in this document, including the resistance testing procedures. Such biological indicators might not be well enough described, or might be used for novel sterilization processes, or might be represented by isolated bioburden microorganisms. If microorganisms other than
42、 risk group 1 (WHO 2004) are included in these biological indicators, appropriate safety measures (e.g. containment) are necessary.Standards exist providing requirements for the validation and control of sterilization processes (see Bibliography).NOTE It is possible that some countries or regions ha
43、ve published other standards covering requirements for sterilization or biological indicators (see Bibliography). ISO 2017 All rights reserved vBS EN ISO 11138-1:2017BS EN ISO 11138-1:2017Sterilization of health care products Biological indicators Part 1: General requirements1 ScopeThis document spe
44、cifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.This document specifies ba
45、sic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.NOTE National or regional regulation
46、s can apply.This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flus
47、hing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.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 re
48、ferences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 11135, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization proce
49、ss for medical devicesISO 11737-1:2006, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on productsISO 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 for medical devicesISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterili
