1、BS EN ISO11138-3:2009ICS 11.080.01NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterilization of healthcare products Biological indicatorsPart 3: Biological indicators for moistheat sterilization processes (ISO11138-3:2006)Copyright European Committee for Stan
2、dardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-This British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30November 2009. BSI 2009ISBN 978 0 580 65850 1Amendments/corrige
3、nda issued since publicationDate CommentsBS EN ISO 11138-3:2009National forewordThis British Standard is the UK implementation of EN ISO11138-3:2009. It is identical to ISO 11138-3:2006. It supersedes BS ENISO 11138-3:2006 which is withdrawn.The UK participation in its preparation was entrusted to T
4、echnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct applicatio
5、n.Compliance with a British Standard cannot confer immunityfrom legal obligations.Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORME
6、N ISO 11138-3May 2009ICS 11.080.01 Supersedes EN ISO 11138-3:2006 English VersionSterilization of health care products - Biological indicators - Part3: Biological indicators for moist heat sterilization processes(ISO 11138-3:2006)Strilisation des produits de sant - Indicateurs biologiques- Partie 3:
7、 Indicateurs biologiques pour la strilisation lachaleur humide (ISO 11138-3:2006)Sterilisation von Produkten fr die Gesundheitsfrsorge -Biologische Indikatoren - Teil 3: Biologische Indikatoren frSterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2006)This European Standard was approved by CEN
8、on 19 April 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may b
9、e obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Ma
10、nagement Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Nor
11、way, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and
12、by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11138-3:2009: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11138-3:2009EN ISO 11138-3:2009 (
13、E) 3 Foreword The text of ISO 11138-3:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11138-3:2009 by Technical Committee CEN/TC 102 “Sterilizers for medical
14、 purposes” 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 November 2009, and conflicting national standards shall be withdrawn at the latest by March 2010
15、. 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 11138-3:2006. This document has been prepared under
16、a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations,
17、 the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
18、 Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 11138-3:2006 has been approved by CEN as a EN ISO 11138-3:2009 without any modification. Copyright European Committee for Standardization Provided by IHS unde
19、r license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11138-3:2009EN ISO 11138-3:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has
20、been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Com
21、munities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requiremen
22、ts of that Directive and associated EFTA regulations. Table ZA Correspondence between this European Standard and Directive 93/42/EEC on medical devices WARNING Other requirements and other EU-directives may be applicable to the product(s) falling within the scope of the standard.“ Clause(s)/sub-clau
23、se(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes4 5, 13 The requirements of ISO 11138-1 apply 5.1 7.2, 7.3 7 7.3 9 10.1 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking perm
24、itted without license from IHS-,-,-BS EN ISO 11138-3:2009ISO 11138-3:2006(E) ISO 2006 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is
25、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 organizations, governmental and non-governmental, in liaison with ISO, also take part
26、in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to pre
27、pare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that
28、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. ISO 11138-3 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the
29、first edition (ISO 11138-3:1995), which has been technically revised. 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
30、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 and formaldehyde sterilization processes Copyright European Committee for Standardization Provided by IHS un
31、der license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11138-3:2009ISO 11138-3:2006(E) iv ISO 2006 All rights reservedIntroduction ISO 11138-1 specifies production, labelling, test methods and performance requirements for the manufacture of b
32、iological indicators including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. This part of ISO 11138 gives specific requirements for those biological indicators intended for use in moist heat sterilization processes. The intent of provid
33、ing requirements in the ISO 11138 series of International Standards is to provide general requirements and requirements for test methods. This series of International Standards represents the current “state-of-the-art” according to the experts representing manufacturers, users and regulatory authori
34、ties 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. Standards exist providing requirements for the validat
35、ion and control of moist heat sterilization (see ISO 17665). NOTE Some countries or regions may have published 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
36、. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11138-3:2009INTERNATIONAL STANDARD ISO 11138-3:2006(E) ISO 2006 All rights reserved 1Sterilization of health care prod
37、ucts Biological indicators Part 3: Biological indicators for moist heat sterilization processes 1 Scope This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of
38、sterilization processes employing moist heat as the sterilizing agent. Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of
39、 ISO 11138 might not be applicable for biological indicators used in such processes. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665. NOTE 2 National or regional regulations may provide requirements for work place safety. 2 Normative ref
40、erences The following referenced documents are indispensable for the application 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 11138-1:2006, Sterilization of health
41、 care products Biological indicators Part 1: General requirements ISO 18472, Sterilization of health care products Biolgical and chemical indicators Test equipment 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11138-1 apply. 4 General requirements
42、The requirements of ISO 11138-1 apply. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11138-3:2009ISO 11138-3:2006(E) 2 ISO 2006 All rights reserved5 Test organism 5.1
43、 The test organisms shall be spores of Geobacillus stearothermophilus or other strains of microorganism of demonstrated equivalent performance as required by this part of ISO 11138. NOTE 1 Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus. NOTE 2 Geobacillus stearot
44、hermophilus ATCC 7953 (NCTC 10007, DSM 22 and CIP 52.81), ATCC 12980 (equivalent to NRRL B-4419), have been found to be suitable. 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
45、hall be determined. NOTE For processes at less than 121 C, microorganisms such as Bacillus subtilis ATCC 35021 (5230) could be used, particularly in sterilization of heat-sensitive liquids. 6 Suspension The requirements of ISO 11138-1 apply. 7 Carrier and primary packaging 7.1 The suitability of the
46、 carrier and primary packaging materials for biological indicators for use in moist heat sterilization processes shall be demonstrated in accordance with the requirements of ISO 11138-1:2006, 5.2 and Annex B. 7.2 The exposure conditions for establishing compliance shall be: a) minimum exposure tempe
47、rature: W 5 C above the manufacturers stated maximum 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
48、 an exception to this part of ISO 11138; c) maximum exposure temperature: as stated by the manufacturer; if not stated by the manufacturer, a temperature of 140 C shall be used; d) exposure time: W 30 min. NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of a moist heat sterilization process. 8 Inoculated carriers and biological indicators The requirements of ISO 11138-1 apply. 9 Population and resistance 9.1 The manufacturer shall state the resistance characteristics in accordance with ISO 11138-1:2006, 6.4
