BS EN ISO 14161-2009 Sterilization of health care products - Biological indicators - Guidance for the selection use and interpretation of results《医疗保健产品的灭菌 生物指示器 选择、使用和检验结果解释用指南》.pdf

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)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STAND

2、ARDS, 01/04/2010 06:43, Uncontrolled Copy, (c) BSIThis British Standardwas published under theauthority 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 Br

3、itish Standard is the UK implementation of EN ISO 14161:2009.It supersedes BS EN ISO 14161:2001 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations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

4、 obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA S

5、TANDARDS, 01/04/2010 06:43, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14161 September 2009 ICS 11.080.01 Supersedes EN ISO 14161:2000English Version Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpreta

6、tion 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) Sterilisation von Produkten fr die Gesundheitsfrsorge - Biologische Indikatoren - Leitfaden fr die Auswahl,

7、 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 which stipulate the conditions for giving this European Standard the status of a national standard wit

8、hout 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 European Standard exists in three official versions (English, French, German). A version in any other languag

9、e 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 national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,

10、 France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMIT

11、EE 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 14161:2009: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 06:43, Uncontrolled Copy, (c

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

14、at 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 organiza

15、tions 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, Roman

16、ia, 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. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 06:43, Uncontrolled Copy, (c) BSIBS EN

17、ISO 14161:2009ISO 14161:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword .v Introductionvi 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 product

18、s.7 5.3 Inoculated carriers 8 5.4 Self-contained biological indicators8 5.5 Other biological indicators.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 bi

19、oburden method.12 7.4 Bioburden method.13 8 Biological indicators in sterilization validation14 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 B

20、iological indicators in routine monitoring15 9.1 General .15 9.2 Placement and handling of biological 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 biol

21、ogical indicator performance by the user17 11.2 Nominal population of test organism17 11.3 Resistance 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) calcu

22、lation.23 11.8 Test equipment 24 12 Culture conditions.24 12.1 General .24 12.2 Incubation temperature.24 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 06:43, Uncontrolled Copy, (c) BSIBS EN ISO 14161:2009ISO 14161:2009(E) iv ISO 2009 All rights reserved12.3 Incubation period.25

23、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 Personnel training .27 15 Storage and handling 27 16 Disposal of biological indicators .27 Annex A (informativ

24、e) Microbiological inactivation kinetics and enumeration techniques28 Annex B (informative) Process challenge devices 34 Annex C (informative) Formulae for fraction negative methods for D value calculations 35 Annex D (informative) Examples of documentation for biological indicators prepared by the

25、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 Bibliography 62 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 06:43, Uncontrolled Copy, (

26、c) BSIBS 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 ISO te

27、chnical 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 close

28、ly 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. Draft

29、 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 docume

30、nt 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), which

31、 has been technically revised. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 06:43, Uncontrolled Copy, (c) BSIBS EN ISO 14161:2009ISO 14161:2009(E) vi ISO 2009 All rights reservedIntroduction This International Standard provides guidance regarding the selection, use and interpret

32、ation of results of biological indicators when used to develop, validate and monitor sterilization 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 reg

33、ard to the sterilization of health care products. The intent of this International Standard is 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 Stan

34、dard, users will find guidance on selection of the correct biological indicator for their particular 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. Ther

35、e is a wide variety of sterilization processes in common use, and biological indicator manufacturers 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

36、indicators to select, use, recover and interpret the results as appropriate for the particular 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

37、 or by the sterilizer process parameters. In addition, the incubation procedure used after exposure 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 recommen

38、dations of the biological indicator manufacturer for storage and use should be followed. After 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

39、intended to indicate that the products in the load being sterilized are sterile. Biological indicators 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 trai

40、ned personnel should conduct these studies. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 06:43, Uncontrolled Copy, (c) BSIBS EN ISO 14161:2009INTERNATIONAL STANDARD ISO 14161:2009(E) ISO 2009 All rights reserved 1Sterilization of health care products Biological indicators Guidan

41、ce 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 biological indicators when used in the development, validation and routine monitoring of sterilization processes. Thi

42、s 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 this International Standard can have useful application for processes and biological indicators not currently a

43、ddressed by existing International Standards, e.g., new and developing sterilization processes. This International Standard does not consider those processes that rely solely on physical removal of microorganisms, e.g., filtration. This International Standard is not intended to apply to combination

44、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 references The following referenced documents are indispensable for the application of this document. For dated

45、 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 products Ethylene oxide Part 1: Requirements for development, validation and routine control of a steriliza

46、tion 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 Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes ISO 11138-3, S

47、terilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes ISO 11138-4, Sterilization of health care products Biological indicators Part 4: Biological indicators for dry heat sterilization processes ISO 11138-5, Sterilization of he

48、alth care products Biological indicators Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products Licensed Copy: Wang Bin,

49、 ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 06:43, Uncontrolled Copy, (c) BSIBS 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 and 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 proc