EN ISO 11138-2-2009 1250 Sterilization of health care products - Biological indicators - Part 2 Biological indicators for ethylene oxide sterilization processes《保健产品的灭菌 生物指示剂 第2部分 .pdf

1、BS EN ISO11138-2:2009ICS 11.080.01NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterilization of healthcare products Biological indicatorsPart 2: Biological indicators forethylene oxide sterilization processes(ISO 11138-2:2006)Copyright European Committee for

2、Standardization 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 65849 5Amendments/cor

3、rigenda issued since publicationDate CommentsBS EN ISO 11138-2:2009National forewordThis British Standard is the UK implementation of EN ISO11138-2:2009. It is identical to ISO 11138-2:2006. It supersedes BS ENISO 11138-2:2006 which is withdrawn.The UK participation in its preparation was entrusted

4、to TechnicalCommittee 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 applic

5、ation.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 N

6、ORMEN ISO 11138-2May 2009ICS 11.080.01 Supersedes EN ISO 11138-2:2006 English VersionSterilization of health care products - Biological indicators - Part2: Biological indicators for ethylene oxide sterilization processes(ISO 11138-2:2006)Strilisation des produits de sant - Indicateurs biologiques- P

7、artie 2: Indicateurs biologiques pour la strilisation loxyde dthylne (ISO 11138-2:2006)Sterilisation von Produkten fr die Gesundheitsfrsorge -Biologische Indikatoren - Teil 2: Biologische Indikatoren frSterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2006)This European Standard was approved by C

8、EN 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 ma

9、y be 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

10、 Management 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,

11、Norway, 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 a

12、nd by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11138-2:2009: 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 11138-2:2009EN ISO 11138-2:200

13、9 (E) 3 Foreword The text of ISO 11138-2:2006 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 11138-2:2009 by Technical Committee CEN/TC 102 “Sterilizers for medi

14、cal 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 2

15、010. 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 11138-2:2006. This document has been prepared und

16、er 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 Regulatio

17、ns, 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, Netherlan

18、ds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 11138-2:2006 has been approved by CEN as a EN ISO 11138-2:2009 without any modification. Copyright European Committee for Standardization Provided by IHS u

19、nder license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11138-2:2009EN ISO 11138-2:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard h

20、as 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

21、Communities 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 Require

22、ments 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-c

23、lause(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 p

24、ermitted without license from IHS-,-,-BS EN ISO 11138-2:2009ISO 11138-2:2006(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

25、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 organizations, governmental and non-governmental, in liaison with ISO, also take pa

26、rt 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

27、prepare 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 th

28、at 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 11138-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces t

29、he first edition (ISO 11138-2:1994), 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 process

30、es 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

31、 under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11138-2:2009ISO 11138-2:2006(E) iv ISO 2006 All rights reservedIntroduction ISO 11138-1 specifies production, labelling, test methods and performance requirements for the manufacture o

32、f biological 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 ethylene oxide sterilization processes. The intent of

33、 providing 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

34、authorities involved in developing the standard. The intent is not to promote the use of biological indicators where such use is not advised, but rather to provide common requirements for the production of those biological indicators that are known to be in use today. Standards exist providing requi

35、rements for the validation and control of ethylene oxide sterilization (see ISO 11135). NOTE Some countries or regions may have published other standards covering requirements for sterilization or biological indicators. Advice on selection, use and interpretation of results when using biological ind

36、icators can be found in ISO 14161. 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 11138-2:2009INTERNATIONAL STANDARD ISO 11138-2:2006(E) ISO 2006 All rights reserved 1

37、Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide 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

38、 use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 C to 65 C. NOTE 1 Requirements for vali

39、dation and control of ethylene oxide sterilization processes are provided by ISO 11135. NOTE 2 National or regional regulations could provide requirements for work place safety. 2 Normative references The following referenced documents are indispensable for the application of this document. For date

40、d 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 care products Biological indicators Part 1: General requirements ISO 18472, Sterilization of health care p

41、roducts Biological 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 The requirements of ISO 11138-1 apply. 5 Test organism 5.1 The test organisms shall be spores of Bacillus

42、atrophaeus, Bacillus subtilis or other strains of microorganisms of demonstrated equivalent performance as required by this part of ISO 11138. NOTE 1 Some strains of Bacillus subtilis have been reclassified as Bacillus atrophaeus. NOTE 2 Bacillus atrophaeus ATCC 9372, NCTC 10073, NCIMB 8058, DSM 227

43、7, NRRL B-4418 and CIP 77.18 have been found to be suitable. 5.2 If a test organism other than Bacillus atrophaeus is used, the suitability of the resistance of that test organism shall be determined. Copyright European Committee for Standardization Provided by IHS under license with CENNot for Resa

44、leNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11138-2:2009ISO 11138-2:2006(E) 2 ISO 2006 All rights reserved6 Suspension The requirements of ISO 11138-1 apply. 7 Carrier and primary packaging 7.1 The suitability of the carrier and primary packaging materials for bi

45、ological indicators for use in ethylene oxide 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 temperature: W 55 C; b) sterilizing agent: ethyl

46、ene oxide gas at a concentration not less than 800 mg/l at W 70 % RH; c) maximum exposure temperature: as stated by the manufacturer; d) exposure time: W 6h. NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of an e

47、thylene oxide 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. 9.2 The viable count shall be stated with

48、increments u 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 W 1,0 106. 9.4 The resistance shall be expressed as the D value in minutes at 54 C and/or 30 C. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes to one decimal place at 54 C or 30 C, or at both temperatures. 9.5 Suspensions, inoculated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D value of not less t