EN ISO 15882-2008 en Sterilization of health care products - Chemical indicators - Guidance for selection use and interpretation of results《医疗保健产品的灭菌化学指示剂选择 使用和检验结果的解释指南》.pdf

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1、BS EN ISO15882:2008ICS 11.080.01,NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterilization of healthcare products Chemical indicators Guidance for selection,use and interpretationof results (ISO15882:2008)This British Standardwas published under the authorit

2、y of theStandards Policy andStrategy Committee on 31 BSI 2009ISBN 978 0 580 55729 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 15882:2008National forewordThis British Standard is the UK implementation of EN ISO 15882:2008.It supersedes BS EN ISO 15882:2003 and which is withd

3、rawn.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 provisions

4、of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.January 2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15882September 2008ICS 11.080.01 Supersedes EN ISO 15882:2003 English VersionSterilizatio

5、n of health care products - Chemical indicators -Guidance for selection, use and interpretation of results (ISO15882:2008)Strilisation des produits de sant - Indicateurs chimiques -Directives pour la slection, lutilisation et linterprtationdes rsultats (ISO 15882:2008)Sterilisation von Produkten fr

6、die Gesundheitsfrsorge -Chemische Indikatoren - Leitfaden fr die Auswahl,Verwendung und Interpretation von Ergebnissen (ISO15882:2008)This European Standard was approved by CEN on 24 August 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions

7、for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three officia

8、l 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 Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belg

9、ium, 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 United Kingdom.EUROPEAN COMMITTEE FOR ST

10、ANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 15882:2008: EBS EN ISO 15882:2008EN ISO 15882:20

11、08 (E) 3 Foreword This document (EN ISO 15882:2008) 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 held by DIN. This European Standard shal

12、l be given the status of a national standard, either by publication of an identical text or by endorsement, 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

13、 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 15882:2003. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bou

14、nd 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, Romania, Slovakia, Slovenia, Spain, Sweden, S

15、witzerland and the United Kingdom. Endorsement notice The text of ISO 15882:2008 has been approved by CEN as a EN ISO 15882:2008 without any modification. BS EN ISO 15882:2008ISO 15882:2008(E) ISO 2008 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Terms and definition

16、s. 1 3 General considerations 3 4 Classes of chemical indicator . 5 4.1 General. 5 4.2 Class 1: Process indicators. 5 4.3 Class 2: Indicators for use in specific tests. 6 4.4 Class 3: Single variable indicators . 6 4.5 Class 4: Multi-variable indicators 8 4.6 Class 5: Integrating indicators 8 4.7 Cl

17、ass 6: Emulating indicators . 9 5 Selection of chemical indicators. 10 6 Use of chemical indicators 10 6.1 Class 1 process indicators 10 6.2 Class 2 indicators . 11 6.3 Class 3, 4, 5 and 6 indicators. 11 6.4 Indicators for use with process challenge devices. 11 7 Interpretation of results from chemi

18、cal indicators 12 7.1 General. 12 7.2 Chemical indicator responses. 12 7.3 Chemical indicators showing “fail” response . 12 8 Chemical indicators in sterility assurance procedures 12 8.1 General. 12 8.2 Record keeping . 13 9 Personnel training 13 10 Storage and handling . 14 11 Labelling 14 11.1 Gen

19、eral. 14 11.2 Indicator marking 14 11.3 Process marking. 14 11.4 Package marking 14 Annex A (informative) Background on the Bowie and Dick test . 16 Annex B (informative) Explanation of the terms “parameter” and “variable” . 19 Annex C (informative) Rationale for the requirements for integrating ind

20、icators and the link to the requirements for biological indicators (BIs) specified in the ISO 11138 series and microbial inactivation (derived from ISO 11140-1) 20 Annex D (informative) Specifications for porosity 27 Annex E (informative) Figure showing relationship of indicator components 29 Biblio

21、graphy . 30 BS EN ISO 15882:2008ISO 15882:2008(E) iv ISO 2008 All rights reservedForeword 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

22、 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 collaborate

23、s 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

24、. 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

25、 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15882 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 15882:2003)

26、 which has been technically revised. BS EN ISO 15882:2008ISO 15882:2008(E) ISO 2008 All rights reserved vIntroduction This International Standard provides guidance for users regarding the selection, use and interpretation of results of chemical indicators intended for use with sterilization processe

27、s employing steam, dry heat, ethylene oxide, or radiation, 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 a

28、re intended primarily for the use of manufacturers of chemical 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 dra

29、wn to the requirements for validation of sterilization 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 s

30、terilization. The actual use/frequency of chemical indicators 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 abo

31、ut the development of sterilization process monitors generally 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 a

32、ppropriate use. The complexity of modern medical technology and the wide variety of sterilization processing techniques and equipment available have made effective sterility assurance programmes more challenging than ever before. BS EN ISO 15882:2008BS EN ISO 15882:2008INTERNATIONAL STANDARD ISO 158

33、82:2008(E) ISO 2008 All rights reserved 1Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results 1 Scope 1.1 This International Standard provides guidance for the selection, use and interpretation of results of chemical indicators used in p

34、rocess 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 change of substances, and which are used to monitor one or more of

35、 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 those processes that rely on physical removal of microorganisms, e

36、.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 definitions For the purposes of this document, the following terms and de

37、finitions 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 process variables based on a chemical or physical change resulting from

38、 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 indicator combination of the indicator agent and its substrate in the

39、 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. BS EN ISO 15882:2008ISO 15882:2008(E) 2 ISO 2008 All rights reserved2.4 indicator agent indicator reagent act

40、ive 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/TS 11139, definition 2.33 2.6 process challenge l

41、ocation 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 para

42、meters and their tolerances. NOTE 2 See Annex B. 2.8 process variable condition within a sterilization process, changes in which alter microbicidal effectiveness ISO/TS 11139, definition 2.35 EXAMPLES Time, temperature, pressure, concentration, humidity, wavelength. NOTE See Annex B. 2.9 resistomete

43、r test equipment designed to create defined combinations of the physical and/or chemical parameters of a sterilization process 2.10 saturated steam water vapour in a state of equilibrium between condensation and evaporation ISO 11140-1 definition 3.11 2.11 stated value SV value or values of a critic

44、al variable at which the indicator is designed to reach its endpoint as defined by the manufacturer ISO 11140-1, definition 3.12 BS EN ISO 15882:2008ISO 15882:2008(E) ISO 2008 All rights reserved 32.12 visible change change defined by the manufacturer, which can be seen in the indicator after exposu

45、re to one or more critical variables of the process NOTE Visible change is used to describe the response of class 1 process indicators. ISO 11140-1, definition 3.15 3 General considerations 3.1 All chemical indicators are intended to provide information about conditions at the location of the indica

46、tor within the sterilizer, sterilizer load or PCD. This can alert the user to potential sterilization process failures. 3.2 The value of the information provided by a chemical indicator is dependent upon the class of indicator, number and location of the indicators, being representative of the condi

47、tions throughout the sterilizer chamber or load. Representative locations for a load configuration should be identified during process validation studies. 3.3 The basic performance descriptors of any chemical indicator are its visible change, graduated response or “endpoint” response. The endpoint r

48、esponse can, for example, involve either the melting of a chemical substance or a chemical reaction resulting in a specified colour change. 3.4 A number of different classes of chemical indicators have been developed to suit different monitoring needs and to provide information about the sterilizati

49、on process. Some types are sensitive to certain specific problems, such as a failure to attain a required temperature. Others might not respond only to a single process variable, but might simultaneously respond to several process variables during the sterilization cycle. Selection of the classes of chemical indicators that are best suited to a particular application should be made only in the context of: What characterizes effective sterilization? Which problems could prevent steriliz