EN ISO 18472-2006 en Sterilization of health care products - Biological and chemical indicators - Test equipment《保健产品的消毒 生物和化学指示剂 试验器械 ISO 18472-2006》.pdf

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1、BRITISH STANDARDBS EN ISO 18472:2006Sterilization of health care products Biological and chemical indicators Test equipment The European Standard EN ISO 18472:2006 has the status of a British StandardICS 11.080.01g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g

2、44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 18472:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2006 BSI 2006ISBN 0 580 48454 8National forewordThis

3、British Standard is the official English language version of EN ISO 18472:2006. It is identical with ISO 18472:2006.The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, which has the responsibility to: A list of organizations

4、represented on this committee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Ind

5、ex”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself conf

6、er immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate t

7、hem in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 28, an inside back cover and a back cover.The BSI copyright notice displayed in this document indic

8、ates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 18472June 2006ICS 11.080.01English VersionSterilization of health care products - Biological and chemicalindicators - Test equipment (ISO 18472:2006)S

9、trilisation des produits de sant - Indicateurs biologiqueset chimiques - Appareillage dessai (ISO 18472:2006)Sterilisation von Produkten fr die Gesundheitsfrsorge -Biologische und chemische Indikatoren - Prfausrstung(ISO 18472:2006)This European Standard was approved by CEN on 19 May 2006.CEN member

10、s are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions 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 t

11、o the Central Secretariat or to any CEN member.This European Standard exists in three official 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 Central Secretariat has the same st

12、atus as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia,

13、Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN

14、national Members.Ref. No. EN ISO 18472:2006: EForeword This document (EN ISO 18472:2006) 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 he

15、ld 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 December 2006, and conflicting national standards shall be withdrawn at the latest by December 2006. According to the CEN/CENELEC Interna

16、l Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherla

17、nds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 18472:2006 has been approved by CEN as EN ISO 18472:2006 without any modifications. EN ISO 18472:2006Reference numberISO 18472:2006(E)INTERNATIONAL STANDARD I

18、SO18472First edition2006-06-01Sterilization of health care products Biological and chemical indicators Test equipment Strilisation des produits de sant Indicateurs biologiques et chimiques Appareillage dessai EN ISO 18472:2006ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative ref

19、erences . 1 3 Terms and definitions. 2 4 Performance requirements for resistometers . 4 4.1 Intended use 4 4.2 Measurement and control capabilities . 4 4.3 Test methods. 4 4.4 Leak test 4 4.5 Steam resistometer performance requirements 4 4.6 Ethylene oxide resistometer performance requirements. 7 4.

20、7 Dry heat (heated air) resistometer performance requirements . 9 4.8 Vaporized hydrogen peroxide process resistometer performance requirements. 11 5 Recording systems. 12 5.1 Measurement systems . 12 5.2 Calibration . 12 6 Documentation 12 6.1 General. 12 6.2 Minimum information . 13 Annex A (infor

21、mative) Additional performance characterization Steam . 14 Annex B (informative) Additional performance characterization Ethylene oxide. 17 Annex C (informative) Additional performance characterization Dry heat . 20 Annex D (informative) Resistometer documentation and derivations 22 Bibliography . 2

22、8 EN ISO 18472:2006iv Foreword 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 technical committees. Each member body interested in a

23、 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 closely with the International Electrotechnical Commissio

24、n (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 International Standards adopted by the technical co

25、mmittees 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 document may be the subject of patent rights. ISO shall no

26、t be held responsible for identifying any or all such patent rights. ISO 18472 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This first edition of ISO 18472 partially replaces ISO 11140-2. EN ISO 18472:2006vIntroduction To test the performance of chemical and

27、 biological indicators, specific test equipment is required. This International Standard specifies the performance requirements for the test equipment to be used in order to establish the response of chemical and biological indicators to critical process variables. This International Standard does n

28、ot apply to test equipment for irradiation indicators or low temperature steam and formaldehyde indicators. Resistometers constitute test equipment designed to create precise and repeatable sterilizing environments, allowing the evaluation of their effect on biological inactivation kinetics, chemica

29、l reactions, material degradation and product bioburden. Resistometers allow precise variation of the environmental conditions and cycle sequences in order to produce controlled physical studies. When used with the defined test methods given in ISO 11138 for biological indicators and ISO 11140 for c

30、hemical indicators, the results of these studies can be used to demonstrate conformance of biological indicators and chemical indicators to these standards. Resistometers differ from conventional sterilizers. Instrumentation selection and control requirements for resistometers are based upon mathema

31、tical models in which rates of reaction, measurement accuracy and process control requirements are evaluated to quantify the effects induced by test equipment-controlled variables. The requirements for accurate measurement, precise control, and rapid rates of change approach limits of commercially a

32、vailable process control and calibration instrumentation accuracy. The measurement and control requirements often prohibit practical validation of a resistometer using procedures that might be employed in a conventional heat or chemical sterilization system. Resistometers are considered test equipme

33、nt rather than sterilizers; therefore, an understanding of instrumentation and process design is critical in clarifying requirements on precision and accuracy. Practical design has to consider the following: achievable measurement and control; acceptable equipment induced variation in test results;

34、economic design (utilizing tight process controls only where required); test method correlation with intended use; historical knowledge applied to test procedures and an understanding of micro-environmental physical phenomena; testing and analysis alternatives, when accurate quantitative determinati

35、ons exceed physical measurement/control limits. EN ISO 18472:2006blank1Sterilization of health care products Biological and chemical indicators Test equipment 1 Scope 1.1 This International Standard specifies the requirements for test equipment to be used to test chemical and biological indicators f

36、or steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the ISO 11138 series for biological indicators. This International Standard also provides informative methods use

37、ful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing. ISO 11138-2, ISO 11138-3, ISO 11138-4, and ISO 11140-1 require the use of resistometers specified in this International Standard, and these resistometers are used in

38、conjunction with the test methods specified in the appropriate parts of ISO 11138 and ISO 11140. NOTE Resistometers for formaldehyde indicators are not included in this International Standard. Test methods using laboratory apparatus for steam-formaldehyde are included in ISO 11138-5, ISO 11140-3 and

39、 ISO 11140-4. 1.2 This International Standard does not address the methods used to demonstrate compliance of biological or chemical indicators to ISO 11138 and ISO 11140, as these are covered in the appropriate parts of these standards. Indicators used with combination processes, such as washer-disi

40、nfection, are not covered by this International Standard. NOTE Test equipment and methods necessary for ISO 11140-3, ISO 11140-4 or ISO 11140-5 are specified in those standards. 1.3 This International Standard does not address safety aspects of the test equipment because these are usually covered by

41、 specific regional, national or local regulations. 2 Normative references 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

42、any amendments) applies. ISO 11138-2, Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processesISO 11138-3, Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilizatio

43、n processes ISO 11138-4, Sterilization of health care products Biological indicators Part 4: Biological indicators for dry heat sterilization processes ISO 11140-1, Sterilization of health care products Chemical indicators Part 1: General requirements EN ISO 18472:20062 ISO 11140-41), Sterilization

44、of health care products Chemical indicators Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization

45、 process for medical devices IEC 60584 (all parts), Thermocouples IEC 60751:1983, Industrial platinum resistance thermometer sensors 3 Terms and definitions For the purpose of this document, the terms and definitions given in ISO 11138, ISO 11140 and the following apply. 3.1 biological indicator tes

46、t system containing viable microorganisms providing a defined resistance to a specified sterilization process ISO/TS 11139:2006, definition 2.3 3.2 calibration set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuri

47、ng system, or values represented by a material measure or a reference material, and the corresponding values realized by standards VIM 1993, definition 6.11 3.3 chemical indicator non-biological indicator system that reveals change in one or more predefined process variables based on a chemical or p

48、hysical change resulting from exposure to a process ISO/TS 11139:2006, definition 2.6 3.4 come-up period time elapsed from the introduction of the sterilizing agent to the attainment of the minimum specified exposure conditions 3.5 come-down period time elapsed from the termination of the exposure p

49、eriod to an established null reaction point 3.6 exposure period time from the initial attainment of the minimum specified exposure conditions to the termination of the exposure period NOTE This phase of the cycle includes the stabilization period and the steady state period 1) To be published. (Revision of ISO 11140-4:2001) EN ISO 18472:200633.7 measurement accuracy closeness of the agreement between the result of a measurement and the true value of the measurement NOTE 1 “Accuracy” is a qualitative concept. NO