EN ISO 14161-2009 en Sterilization of health care products - Biological indicators - Guidance for the selection use and interpretation of results《医疗保健产品的消毒 生物指示剂 选择 使用和检验结果解释指南》.pdf

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1、BS EN ISO14161:2009ICS 11.080.01NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterilization of healthcare products Biological indicators Guidance forthe selection, useand interpretationof results (ISO14161:2009)This British Standardwas published under theautho

2、rity of the StandardsPolicy and StrategyCommittee on 31 January2010 BSI 2010ISBN 978 0 580 56912 8Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 14161:2009National forewordThis British Standard is the UK implementation of EN ISO 14161:2009.It supersedes BS EN ISO 14161:2001 whi

3、ch is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations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

4、 provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14161 September 2009 ICS 11.080.01 Supersedes EN ISO 14161:2000English Version Steriliz

5、ation of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) Strilisation des produits de sant - Indicateurs biologiques - Directives gnrales pour la slection, lutilisation et linterprtation des rsultats (ISO 14161:2009) Steri

6、lisation von Produkten fr die Gesundheitsfrsorge - Biologische Indikatoren - Leitfaden fr die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO 14161:2009) This European Standard was approved by CEN on 31 July 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations

7、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 to the CEN Management Centre or to any CEN member. This Europea

8、n 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 Management Centre has the same status as the official versions. CEN members are the natio

9、nal standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and U

10、nited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14161

11、:2009: EBS EN ISO 14161:2009EN ISO 14161:2009 (E) 3 Foreword This document (EN ISO 14161:2009) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which

12、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 March 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility

13、 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 14161:2000. According to the CEN/CENELEC Internal Regulations, the national standards organ

14、izations 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, Norway, Poland, Portugal, Ro

15、mania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14161:2009 has been approved by CEN as a EN ISO 14161:2009 without any modification. BS EN ISO 14161:2009ISO 14161:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword .v Introd

16、uctionvi 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 General .5 5 Characteristics of biological indicators 7 5.1 General .7 5.2 Test organism suspension for direct inoculation of products.7 5.3 Inoculated carriers 8 5.4 Self-contained biological indicators8 5.5 Other biological ind

17、icators.9 6 Selection of supplier .9 6.1 General .9 6.2 Documentation 10 7 Biological indicators in process development.11 7.1 General .11 7.2 Overkill approach 12 7.3 Combined biological indicator and bioburden method.12 7.4 Bioburden method.13 8 Biological indicators in sterilization validation14

18、8.1 General .14 8.2 Placement and handling of biological indicators 14 8.3 Sterilizer qualification .14 8.4 Performance qualification 14 8.5 Review and approval of validation 15 8.6 Requalification.15 9 Biological indicators in routine monitoring15 9.1 General .15 9.2 Placement and handling of biolo

19、gical indicators 15 9.3 Process challenge device (PCD)16 10 Results16 10.1 General .16 10.2 Interpretation of results 16 11 Application of biological indicator standards 17 11.1 General assessment of biological indicator performance by the user17 11.2 Nominal population of test organism17 11.3 Resis

20、tance determination.18 11.4 z value determination 20 11.5 F(T, z)equivalent sterilization value determination .22 11.6 Establishing spore-log-reduction (SLR) .23 11.7 Sterility assurance level (SAL) calculation.23 11.8 Test equipment 24 12 Culture conditions.24 12.1 General .24 12.2 Incubation tempe

21、rature.24 BS EN ISO 14161:2009ISO 14161:2009(E) iv ISO 2009 All rights reserved12.3 Incubation period.25 12.4 Choice of growth medium.25 13 Third-party requirements 26 13.1 General26 13.2 Minimum requirements for replicates and total number of biological indicators 26 13.3 Test equipment 26 14 Perso

22、nnel training .27 15 Storage and handling 27 16 Disposal of biological indicators .27 Annex A (informative) Microbiological inactivation kinetics and enumeration techniques28 Annex B (informative) Process challenge devices 34 Annex C (informative) Formulae for fraction negative methods for D value c

23、alculations 35 Annex D (informative) Examples of documentation for biological indicators prepared by the user .50 Annex E (informative) Calculation of z value54 Annex F (informative) D value determination by survivor curve method57 Annex G (informative) Survival-kill response characteristics 61 Bibl

24、iography 62 BS EN ISO 14161:2009ISO 14161:2009(E) ISO 2009 All rights reserved vForeword ISO (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

25、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 in the work. ISO collaborates

26、 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 prepare International Standards.

27、 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 some of the elements of this

28、document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14161 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 14161:2000),

29、 which has been technically revised. BS EN ISO 14161:2009ISO 14161:2009(E) vi ISO 2009 All rights reservedIntroduction This International Standard provides guidance regarding the selection, use and interpretation of results of biological indicators when used to develop, validate and monitor steriliz

30、ation processes. The procedures described in this International Standard are of a general nature and do not, of themselves, constitute a comprehensive development, validation or monitoring programme with regard to the sterilization of health care products. The intent of this International Standard i

31、s not to mandate the use of biological indicators in a process but, if they are used, to provide guidance for their proper selection and use in order to obviate misleading results. In this International Standard, users will find guidance on selection of the correct biological indicator for their par

32、ticular sterilization process and critical parameters as well as guidance on its appropriate use. The user should select a biological indicator that is appropriate for the particular process to be used. There is a wide variety of sterilization processes in common use, and biological indicator manufa

33、cturers are not able to foresee all possible uses of their product. Manufacturers, therefore, label biological indicators according to their intended use. It is the responsibility of the users of biological indicators to select, use, recover and interpret the results as appropriate for the particula

34、r sterilization process used. The certified performance of a biological indicator can be adversely affected by the conditions of storage and transport prior to its use, by the use of the biological indicator or by the sterilizer process parameters. In addition, the incubation procedure used after ex

35、posure to the process, including outgrowth temperature and culture medium type, supplier and specific lot, can affect measured resistance as a function of recovery and growth. For these reasons, the recommendations of the biological indicator manufacturer for storage and use should be followed. Afte

36、r exposure, biological indicators should be aseptically transferred (if applicable) and incubated as specified by the biological indicator manufacturer. It should be noted that biological indicators are not intended to indicate that the products in the load being sterilized are sterile. Biological i

37、ndicators are utilized to test the effectiveness of a given sterilization process and the equipment used, by assessing microbial lethality according to the concept of sterility assurance level. Suitably trained personnel should conduct these studies. BS EN ISO 14161:2009INTERNATIONAL STANDARD ISO 14

38、161:2009(E) ISO 2009 All rights reserved 1Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results 1 Scope This International Standard provides guidance for the selection, use and interpretation of results from application of biologica

39、l indicators when used in the development, validation and routine monitoring of sterilization processes. This International Standard applies to biological indicators for which International Standards exist. NOTE 1 See, for example, the ISO 11138 series. NOTE 2 The general information provided in thi

40、s International Standard can have useful application for processes and biological indicators not currently addressed by existing International Standards, e.g., new and developing sterilization processes. This International Standard does not consider those processes that rely solely on physical remov

41、al of microorganisms, e.g., filtration. This International Standard is not intended to apply to combination processes using, for example, washer disinfectors or flushing and steaming of pipelines. This International Standard is not intended to apply to liquid sterilization processes. 2 Normative ref

42、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 11135-1, Sterilization of health care

43、 products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11138-1:2006, Sterilization of health care products Biological indicators Part 1: General requirements ISO 11138-2, Sterilization of health care products B

44、iological indicators Part 2: Biological indicators for ethylene oxide sterilization processes ISO 11138-3, Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes ISO 11138-4, Sterilization of health care products Biological in

45、dicators Part 4: Biological indicators for dry heat sterilization processes ISO 11138-5, Sterilization of health care products Biological indicators Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes ISO 11737-1, Sterilization of medical devices Microbio

46、logical methods Part 1: Determination of a population of microorganisms on products BS EN ISO 14161:2009ISO 14161:2009(E) 2 ISO 2009 All rights reservedISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation an

47、d routine control of a sterilization process for medical devices ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 18472:2006, Sterilization of health care products

48、 Biological and chemical indicators Test equipment 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accreditation procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks

49、NOTE 1 See ISO/IEC 170113. NOTE 2 Accreditation does not itself qualify the laboratory to approve any particular product. However, accreditation can be relevant to approval and certification authorities when they decide whether or not to accept data produced by a given laboratory in connection with their own activities. 3.2 aseptic technique conditions and procedures used to exclude the introduction of microbial contamination 3.3 bioburden population of viable microorganisms on or in a product and/or st