DIN EN ISO 15882-2008 Sterilization of health care products - Chemical indicators - Guidance for selection use and interpretation of results (ISO 15882 2008) English version of DIN.pdf

1、December 2008DEUTSCHE NORM English price group 16No part of this standard 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 11.080.01!$Tq3“149781

2、6www.din.deDDIN EN ISO 15882Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results(ISO 15882:2008)English version of DIN EN ISO 15882:2008-12Sterilisation von Produkten fr die Gesundheitsfrsorge Chemische Indikatoren Leitfaden fr die Auswa

3、hl, Verwendung und Interpretation von Ergebnissen(ISO 15882:2008)Englische Fassung DIN EN ISO 15882:2008-12SupersedesDIN EN ISO 15882:2003-10www.beuth.deDocument comprises 39 pagesDIN EN ISO 15882:2008-12 2 National foreword This standard has been prepared by Technical Committee ISO/TC 198 “Steriliz

4、ation of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-04-08

5、AA Indikatoren. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 8601 DIN ISO 8601 ISO 9001 DIN EN ISO 9001 ISO 11135-1 DIN EN ISO 11135-1 ISO/TS 11135-2 DIN ISO/TS 11135-2 ISO 11137-1 DIN EN ISO 11137-1 ISO 11138-2 DIN EN ISO 11138-2 IS

6、O 11138-3 DIN EN ISO 11138-3 ISO 11138-5 DIN EN ISO 11138-5 ISO 11140-1 DIN EN ISO 11140-1 ISO 11140-3 DIN EN ISO 11140-3 ISO 11140-4 DIN EN ISO 11140-4 ISO 14161 DIN EN ISO 14161 ISO 14937 DIN EN ISO 14937 ISO 17665-1 DIN ISO/TS 17665-2 ISO 18472 DIN EN ISO 18472 Amendments This standard differs fr

7、om DIN EN ISO 15882:2003-10 as follows: a) Clause 2 “Normative references” has been deleted. b) Terms and definitions have been supplemented and brought in line with current standards on chemical indicators (see ISO 11140-1 and ISO/TS 11139). c) The class designation of indicators has been brought i

8、n line with the new classification according to DIN EN ISO 11140-1; “class B” has been replaced by “class 2”. d) Table 1 “Variables for sterilization processes” and Table 2 “Test and performance requirements for class 1 process indicators for steam” have been revised. e) Information relating to the

9、labelling of indicators (clause 11) has been extended. f) Informative annexes relating to the explanation of the terms “parameter” and “variable” (Annex B), the rationale for the requirements for integrating indicators (Annex C), specifications for porosity (Annex D) and to the relationship of indic

10、ator components (Annex E) have been added. g) The standard has been editorially revised. Previous editions DIN EN ISO 15882: 2003-10 EN ISO 15882:2008-12 3 National Annex NA (informative) Bibliography DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 11135-1, Sterilization of healt

11、h care products Ethylene oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterili

12、zation process for medical devices 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 3: Biological indicators fo

13、r moist heat sterilization processes DIN EN ISO 11138-5, Sterilization of health care products Biological indicators Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes DIN EN ISO 11140-1, Sterilization of health care products Chemical indicators Part 1:

14、General requirements DIN EN ISO 11140-3, Sterilization of health care products Chemical indicators Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test DIN EN ISO 11140-4, Sterilization of health care products Chemical indicators Part 4: Class 2 indicators as a

15、n alternative to the Bowie and Dick-type test for detection of steam penetration DIN EN ISO 14161, Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results DIN EN ISO 14937, General requirements for characterization of a sterilizing ag

16、ent and the development, validation and routine control of a sterilization process for medical devices 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 devices DIN EN I

17、SO 18472, Sterilization of health care products Biological and chemical indicators Test equipment DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times DIN ISO/TS 11135-2, Sterilization of health care products Ethylene oxide Part 2: Guidance on

18、 the application of ISO 11135-1 DIN ISO/TS 17665-2, Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1 DIN EN ISO 15882:2008-12 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15882 September 2008 ICS 11.080

19、.01 Supersedes EN ISO 15882:2003English Version Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008) Strilisation des produits de sant - Indicateurs chimiques -Directives pour la slection, lutilisation et linterprtat

20、ion des rsultats (ISO 15882:2008) Sterilisation von Produkten fr die Gesundheitsfrsorge - Chemische Indikatoren - Leitfaden fr die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO 15882:2008) This European Standard was approved by CEN on 24 August 2008. CEN members are bound to comply wit

21、h the CEN/CENELEC Internal Regulations 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 Ce

22、ntre or to any CEN member. This European 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 offic

23、ial 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, Norway, Poland, Portugal, Romania, Slovakia, Slov

24、enia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN

25、 national Members. Ref. No. EN ISO 15882:2008: E2 DIN EN ISO 15882:2008-12 EN ISO 15882:2008 (E) Contents Page Foreword .3 Introduction.4 1 Scope5 2 Terms and definitions .5 3 General considerations.7 4 Classes of chemical indicator9 4.1 General .9 4.2 Class 1: Process indicators .9 4.3 Class 2: Ind

26、icators for use in specific tests .10 4.4 Class 3: Single variable indicators10 4.5 Class 4: Multi-variable indicators 12 4.6 Class 5: Integrating indicators.12 4.7 Class 6: Emulating indicators 13 5 Selection of chemical indicators .14 6 Use of chemical indicators.14 6.1 Class 1 process indicators.

27、14 6.2 Class 2 indicators15 6.3 Class 3, 4, 5 and 6 indicators .15 6.4 Indicators for use with process challenge devices .15 7 Interpretation of results from chemical indicators 16 7.1 General .16 7.2 Chemical indicator responses .16 7.3 Chemical indicators showing “fail” response16 8 Chemical indic

28、ators in sterility assurance procedures.16 8.1 General .16 8.2 Record keeping17 9 Personnel training.17 10 Storage and handling18 11 Labelling.18 11.1 General .18 11.2 Indicator marking 18 11.3 Process marking18 11.4 Package marking.18 Annex A (informative) Background on the Bowie and Dick test20 An

29、nex B (informative) Explanation of the terms “parameter” and “variable”23 Annex C (informative) Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators (BIs) specified in the ISO 11138 series and microbial inactivation (derived from ISO 11

30、140-1).24 Annex D (informative) Specifications for porosity 31 Annex E (informative) Figure showing relationship of indicator components.33 Bibliography34 3 DIN EN ISO 15882:2008-12 EN ISO 15882:2008 (E) Foreword This document (EN ISO 15882:2008) has been prepared by Technical Committee ISO/TC 198 “

31、Sterilization of health care products“ in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical 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 endorsemen

32、t, at the latest by March 2009, and conflicting national standards shall be withdrawn at the latest by March 2009. 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 an

33、y or all such patent rights. This document supersedes EN ISO 15882:2003. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Esto

34、nia, 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 notice The text of ISO 15882:2008 has been approved by CEN

35、 as a EN ISO 15882:2008 without any modification. Introduction This International Standard provides guidance for users regarding the selection, use and interpretation of results of chemical indicators intended for use with sterilization processes employing steam, dry heat, ethylene oxide, or radiati

36、on, low temperature steam and formaldehyde (LTSF), or vapourized hydrogen peroxide as documented in ISO 11140-1 13. The ISO 11140 12, 13, 14, 15, 16series of standards specifies performance requirements for chemical indicators. These standards are intended primarily for the use of manufacturers of c

37、hemical indicators. The guidance in this document is of a general nature; chemical indicators do not, of themselves, constitute a comprehensive monitoring programme with regard to the sterilization of health care products. Users attention is drawn to the requirements for validation of sterilization

38、processes specified in ISO 14937 18for general processes, the ISO 17665 19, 20series for moist heat sterilization, the ISO 11135 5, 6series for ethylene oxide sterilization, ISO 11137-1 7for radiation sterilization and ISO 20857 22for dry heat sterilization. The actual use/frequency of chemical indi

39、cators might be regulated by international and or national standards as well as by local regulatory authorities. The need for convenient and rapid means of detecting sterilization problems occurring during sterilization processes has brought about the development of sterilization process monitors ge

40、nerally referred to as “chemical indicators.” In this International Standard, users will find guidance on selection of the correct chemical indicator for their particular sterilization process and critical parameters as well as guidance on its appropriate use. The complexity of modern medical techno

41、logy and the wide variety of sterilization processing techniques and equipment available have made effective sterility assurance programmes more challenging than ever before. 4 DIN EN ISO 15882:2008-12 EN ISO 15882:2008 (E) 1 Scope 1.1 This International Standard provides guidance for the selection,

42、 use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. This International Standard applies to indicators that show exposure to sterilization processes by means of physical and/or chemical

43、 change of substances, and which are used to monitor one or more of the variables required of a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism. 1.2 This International Standard does not consider indicators for use in

44、 those processes that rely on physical removal of microorganisms, e.g. filtration. 1.3 This International Standard is not intended to apply to indicators for use in combination processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place). 2 Terms and defini

45、tions For the purposes of this document, the following terms and definitions apply. NOTE A vocabulary of terms used for sterilization of health care products is provided in ISO/TS 1113911. 2.1 chemical indicator non-biological indicator test system that reveals change in one or more pre-defined proc

46、ess variables based on a chemical or physical change resulting from exposure to a process ISO/TS 11139, definition 2.6 2.2 endpoint point of the observed change as defined by the manufacturer occurring after the indicator has been exposed to specified stated values ISO 11140-1, definition 3.3 2.3 in

47、dicator combination of the indicator agent and its substrate in the final form in which it is intended to be used ISO 11140-1 definition 3.5 NOTE 1 An indicator system in combination with a specific test load is also termed an indicator. NOTE 2 See Annex E. 5 DIN EN ISO 15882:2008-12 EN ISO 15882:20

48、08 (E) 2.4 indicator agent indicator reagent active substance(s) or combination of substances ISO 11140-1, definition 3.6 NOTE See Annex E. 2.5 process challenge device PCD item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process ISO/T

49、S 11139, definition 2.33 2.6 process challenge location PCL site which represents “worst case” conditions as they are given for sterilizing agent(s) in the goods to be sterilized 2.7 process parameter specified value for a process variable ISO/TS 11139, definition 2.34 NOTE 1 The specification for a sterilization process includes the process parameters and their tolerances. NOTE 2 See Annex B. 2.8 process variable condition within a sterilizat