1、March 2010 Translation by DIN-Sprachendienst.English price group 26No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、11.080.20!$“1619897www.din.deDDIN EN ISO 14161Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results(ISO 14161:2009)English translation of DIN EN ISO 14161:2010-03Sterilisation von Produkten fr die Gesundheitsfrsorge Biologische Indi
3、katoren Leitfaden fr die Auswahl, Verwendung und Interpretation von Ergebnissen(ISO 14161:2009)Englische bersetzung von DIN EN ISO 14161:2010-03Strilisation des produits de sant Indicateurs biologiques Directives gnrales pour la slction, lutilisation et linterprtation des rsultats(ISO 14161:2009)Tra
4、duction anglaise de DIN EN ISO 14161:2010-03SupersedesDIN EN ISO 14161:2001-02www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 72 pages03.10 DIN EN ISO 14161:2010-03 2 A comma is used as the decimal marker. National foreword This standar
5、d 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” (Secretariat: DIN, Germany), with the active participation of German experts. The responsible German body involved in
6、its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-04-08 AA Indikatoren. ISO 14161:2009-09 contains the following errors: Errors identified in ISO 14161:2009-09: To be corrected to: under 11.3.3 a) “exposure periods” “exposure conditions” parenthe
7、ses are missing from equation (5) on page 20 of ISO 14161 =rnNtDlnloglog10010=rnNtDlnloglog10010the indices “i” should be subscripts in equation (C.2) on page 37 of ISO 14161 nirinr+=11iii iiiiinrnr+=11 in the explanation to equation (C.14) on page 43 of ISO 14161 the index below the sigma sign is n
8、ot correct Where 11ikir Where =11kiir in equation (C.22) in C.3.3.3.2 on page 47 of ISO 14161 the logarithm is incorrect aNt1lnloglog100aNt1lnloglog10010in E.4 on page 55 of ISO 14161 reference is made to the wrong equation “The z valueusing Equation (E.7)” “The z valueusing Equation (E.6)”in E.5 on
9、 page 56 of ISO 14161 reference is made to the wrong equation “The coefficient of determination “The coefficient of determination Readers should note that all of the corrections have been made in the German version of this standard (DIN EN ISO 14161), and correspondingly in this English version. ISO
10、 has been informed and Germany has made a proposal for a Corrigendum to ISO 14161:2009-09. Amendments This standard differs from DIN EN ISO 14161:2001-02 as follows: a) Terminology has been harmonized with current standards on biological indicators (see ISO 11138-1 and ISO/TS 11139). b) Subclauses o
11、n the interpretation of results and resistance determination have been modified. using Equation (E.9)” using Equation (E.8)” DIN EN ISO 14161:2010-03 3 c) Requirements for z value determination, equivalent sterilization value determination and establishing spore-log-reduction (SLR) are now specified
12、. d) Table 1 giving test methods and requirements for indicators has been revised. e) Annex C on calculating the D value using fraction negative analysis has been revised. f) Informative annexes on calculating the z value and on D value determination by the survivor curve method have been included.
13、g) The standard has been editorially revised. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 9000 DIN EN ISO 9000 ISO 9001 DIN EN ISO 9001 ISO 11135-1 DIN EN ISO 11135-1 ISO 11138-1 DIN EN ISO 11138-1 ISO 11138-2 DIN EN ISO 11138-2 ISO
14、 11138-3 DIN EN ISO 11138-3 ISO 11138-4 DIN EN ISO 11138-4 ISO 11138-5 DIN EN ISO 11138-5 ISO 11737-1 DIN EN ISO 11737-1 ISO 11737-2 DIN EN ISO 11737-2 ISO 13485 DIN EN ISO 13485 ISO 14937 DIN EN ISO 14937 ISO 17665-1 DIN EN ISO 17665-1 ISO 18472 DIN EN ISO 18472 ISO 19011 DIN EN ISO 19011 ISO 20857
15、 DIN EN ISO 20857 (at present at draft stage) ISO/IEC 17011 DIN EN ISO/IEC 17011 ISO/IEC 17025 DIN EN ISO/IEC 17025 Previous editions DIN EN ISO 14161: 2001-02 DIN EN ISO 14161:2010-03 4 National Annex NA (informative) Bibliography DIN EN ISO 9000, Quality management systems Fundamentals and vocabul
16、ary DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11138-1, Sterilization of health ca
17、re products Biological indicators Part 1: General requirements DIN EN ISO 11138-2, Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes DIN EN ISO 11138-3, Sterilization of health care products Biological indicators Part
18、 3: Biological indicators for moist heat sterilization processes DIN EN ISO 11138-4, Sterilization of health care products Biological indicators Part 4: Biological indicators for dry heat sterilization processes DIN EN ISO 11138-5, Sterilization of health care products Biological indicators Part 5:
19、Biological indicators for low-temperature steam and formaldehyde sterilization processes DIN EN ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products DIN EN ISO 11737-2, Sterilization of medical devices Microbiologic
20、al methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14937, Sterilization of health care products General requirements for
21、characterization of a sterilizing agent and the development, validation and routine control of a sterilization process DIN EN 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
22、devices DIN EN ISO 18472, Sterilization of health care products Biological and chemical indicators Test equipment DIN EN ISO 19011, Guidelines for quality and/or environmental management systems auditing DIN EN ISO 20857, Sterilization of health care products Dry heat Requirements for the developmen
23、t, validation and routine control of a sterilization process for medical devices (at present at draft stage) DIN EN ISO/IEC 17011, Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies DIN EN ISO/IEC 17025, General requirements for the competenc
24、e of testing and calibration laboratories EUROPEAN 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 interpretation of resu
25、lts (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, Verwendung
26、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 without any alt
27、eration. 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 language made by tr
28、anslation 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, France, Ger
29、many, 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 KOMITEE FR NORMUN
30、G 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: EDIN EN ISO 14161:2010-03 EN ISO 14161:2009 (E) Contents Page Foreword4 Introduction .5 1 Scope 6 2 Normati
31、ve references 6 3 Terms and definitions .7 4 General. 10 5 Characteristics of biological indicators . 12 5.1 General. 12 5.2 Test organism suspension for direct inoculation of products 12 5.3 Inoculated carriers 13 5.4 Self-contained biological indicators. 13 5.5 Other biological indicators 14 6 Sel
32、ection of supplier 14 6.1 General. 14 6.2 Documentation 15 7 Biological indicators in process development 16 7.1 General. 16 7.2 Overkill approach 17 7.3 Combined biological indicator and bioburden method 17 7.4 Bioburden method 18 8 Biological indicators in sterilization validation .19 8.1 General.
33、 19 8.2 Placement and handling of biological indicators 19 8.3 Sterilizer qualification 19 8.4 Performance qualification 20 8.5 Review and approval of validation 20 8.6 Requalification 20 9 Biological indicators in routine monitoring .20 9.1 General. 20 9.2 Placement and handling of biological indic
34、ators 21 9.3 Process challenge device (PCD). 21 10 Results . 21 10.1 General. 21 10.2 Interpretation of results . 21 11 Application of biological indicator standards . 22 11.1 General assessment of biological indicator performance by the user. 22 11.2 Nominal population of test organism . 22 11.3 Re
35、sistance determination 23 11.4 z value determination . 25 11.5 F(T, z)equivalent sterilization value determination 27 11.6 Establishing spore-log-reduction (SLR). 28 11.7 Sterility assurance level (SAL) calculation 28 11.8 Test equipment . 29 12 Culture conditions 29 12.1 General. 29 2 DIN EN ISO 14
36、161:2010-03 EN ISO 14161:2009 (E) 12.2 Incubation temperature.29 12.3 Incubation period 30 12.4 Choice of growth medium 30 13 Third-party requirements31 13.1 General .31 13.2 Minimum requirements for replicates and total number of biological indicators 31 13.3 Test equipment31 14 Personnel training.
37、32 15 Storage and handling32 16 Disposal of biological indicators .32 Annex A (informative) Microbiological inactivation kinetics and enumeration techniques .33 Annex B (informative) Process challenge devices39 Annex C (informative) Formulae for fraction negative methods for D value calculations (ad
38、apted from ISO 11138-1:2006, Annex D) 40 Annex D (informative) Examples of documentation for biological indicators prepared by the user.55 Annex E (informative) Calculation of z value (adapted from ISO 11138-3:2006, Annex B)59 Annex F (informative) D value determination by survivor curve method (ada
39、pted from ISO 11138-1:2006, Annex C) .62 Annex G (informative) Survival-kill response characteristics (adapted from ISO 11138-1:2006, Annex E) .66 Bibliography67 3DIN EN ISO 14161:2010-03 EN ISO 14161:2009 (E) 4 Foreword This European Standard shall be given the status of a national standard, either
40、 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 that some of the elements of this document may be the subject of patent rights. CEN and/or CEN
41、ELEC 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 organizations of the following countries are bound to implement this European Standard: Austria, Bel
42、gium, 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 the United Kingdom. Endorsement notic
43、e The text of ISO 14161:2009 has been approved by CEN as a EN ISO 14161:2009 without any modification. This document (EN ISO 14161:2009) has been prepared by Technical Committee ISO/TC 198 “Sterilization of purposes” the secretariat of which is held by DIN. health care products” in collaboration wit
44、h Technical Committee CEN/TC 102 “Sterilizers for medical DIN EN ISO 14161:2010-03 EN ISO 14161:2009 (E) 5Introduction This International Standard provides guidance regarding the selection, use and interpretation of results of biological indicators when used to develop, validate and monitor steriliz
45、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
46、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
47、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
48、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 particular sterilization process used. The certified performance of a biological indicator can be adversely affected by the c
