EN ISO 11140-4-2007 en Sterilization of health care products - Chemical indicators - Part 4 Class 2 indicators as an alternative to the Bowie and Dicktype test for detection of ste.pdf

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1、BRITISH STANDARDBS EN ISO 11140-4:2007Sterilization of health care products Chemical indicators Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetrationThe European Standard EN ISO 11140-4:2007 has the status of a British StandardICS 11.080.01g4

2、9g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 11140-4:2007This British Standard was published under the authority of the Standards Policy

3、and Strategy Committee on 30 April 2007 BSI 2007ISBN 978 0 580 50501 0National forewordThis British Standard was published by BSI. It is the UK implementation of EN ISO 11140-4:2007. It supersedes BS EN 867-4:2001 which is withdrawn.The UK participation in its preparation was entrusted to Technical

4、Committee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations represented on LBI/35 can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance w

5、ith a British Standard cannot confer immunity from legal obligations.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11140-4March 2007ICS 11.080.01 Supersedes EN 867-4:2000 English VersionSterilization of health care products - Chemical

6、indicators - Part4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)Strilisation des produits de sant - Indicateurs chimiques -Partie 4: Indicateurs de Classe 2 comme alternative lessai de Bowie et Dick pour la dtection de la

7、pntrationde la vapeur (ISO 11140-4:2007)Sterilisation von Produkten fr die Gesundheitsfrsorge -Chemische Indikatoren - Teil 4: Indikatoren der Klasse 2,die alternativ zum Bowie-Dick-Test fr den Nachweis derDampfdurchdringung verwendet werden (ISO 11140-4:2007)This European Standard was approved by C

8、EN on 14 March 2007.CEN members 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 ma

9、y 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN

10、 Management Centre has the same status as theofficial 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,

11、Norway, Poland, Portugal,Romania, Slovakia, 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 2007 CEN All rights of exploitation in any form

12、 and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11140-4:2007: EForeword This document (EN ISO 11140-4:2007) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Committee CEN/TC 102 “Sterilizers for m

13、edical 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 endorsement, at the latest by September 2007, and conflicting national standards shall be withdrawn at the latest by Se

14、ptember 2007. This document supersedes EN 867-4:2000. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). The series EN ISO 11140 consists of the following parts under

15、 the general title Sterilization of health care products - Chemical indicators: Part 1: General requirements Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam

16、 penetration Attention is drawn to the fact that the series ISO 11140 additionally consists of Part 5: Class 2 indicators for Bowie and Dick-type air removal tests. However, this Part of ISO 11140 will not be part of the series EN ISO 11140 because CEN/TC 102 decided not to adopt ISO 11140-5 as a Eu

17、ropean Standard. In addition, reference is made to EN 867-5 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers type B and type S and to EN ISO 15882 Sterilization of health car

18、e products - Chemical indicators - Guidance for selection, use and interpretation of results: Both standards are currently being revised under the Vienna Agreement (ISO/TC 198 lead). According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries ar

19、e 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, Romania, Slovakia, Slovenia, Spain, Swed

20、en, Switzerland and United Kingdom. Endorsement notice The text of ISO 11140-4:2007 has been approved by CEN as EN ISO 11140-4:2007 without any modifications. EN ISO 11140-4:2007Reference numberISO 11140-4:2007(E)INTERNATIONAL STANDARD ISO11140-4Second edition2007-03-15Sterilization of health care p

21、roducts Chemical indicators Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration Strilisation des produits de sant Indicateurs chimiques Partie 4: Indicateurs de Classe 2 comme alternative lessai de Bowie et Dick pour la dtection de la pntra

22、tion de la vapeur EN ISO 11140-4:2007ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements. 3 5 Indicator system format . 4 6 Performance requirements 4 7 Packaging and labelling. 6 8 Quality assurance. 7 Annex A (norm

23、ative) Determination of indicator strength during and after steam sterilization . 8 Annex B (normative) Standard test cycles 10 Annex C (normative) Estimation of visual difference between colour of the substrate and of the changed or unchanged indicator system by determination of relative reflectanc

24、e density 15 Annex D (normative) Determination of uniform colour change on exposure to saturated steam 19 Annex E (normative) Determination of equivalence of the alternative indicator to the Bowie and Dick test . 20 Annex F (normative) Determination of reproducibility of fail conditions created in a

25、 standard test pack by air injection, air leak and retained air systems . 22 Annex G (normative) Determination of indicator colour change on exposure to dry heat 26 Annex H (normative) Determination of shelf life of product 27 Annex I (normative) Accelerated ageing of test samples 28 Annex J (normat

26、ive) Steam exposure apparatus and steam for test purposes 29 Annex K (normative) Standard test pack. 32 Annex L (normative) Air injection system . 33 Bibliography . 35 EN ISO 11140-4:2007iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standa

27、rds bodies (ISO member bodies). The work of preparing International Standards is normally carried out through 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 organ

28、izations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given i

29、n the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. 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 %

30、 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 not be held responsible for identifying any or all such patent rights. ISO 11140-4 was prepared by Technical Committee ISO/TC 198, Ste

31、rilization of health care products. This second edition cancels and replaces the first edition (ISO 11140-4:2001) which has been technically revised. ISO 11140 consists of the following parts, under the general title Sterilization of health care products Chemical indicators: Part 1: General requirem

32、ents Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration Part 5: Class 2 indicators for Bowie and Dick-type air removal tests EN ISO 11140-4:2007vIn

33、troduction The Bowie and Dick test is a performance test for steam sterilizers for wrapped goods and porous loads. As such it is performed during the demonstration of conformance of steam sterilizers to EN 285 and as a routine test of performance in ISO 17665-1. The test method is described in EN 28

34、5. A failure of the Bowie and Dick test is symptomatic of a number of potential problems with the sterilizer that could compromise the uniform sterilization of a load to be processed. This failure is not conclusive proof that the fault in the sterilizer is due to air retention, air leakage or non-co

35、ndensable gases, and it can be necessary to investigate other causes of failure. The Bowie and Dick test was conceived as a test for successful air removal from high-vacuum porous-load sterilizers used in the sterilization of health care products 1. A successful Bowie and Dick test indicates rapid a

36、nd even penetration of steam into the test pack. The presence of air within the pack, due to an inefficient air removal stage, an air leak during this stage or non-condensable gases in the steam supply, are circumstances which can lead to failure of the test. The result of the test may also be affec

37、ted by other factors which inhibit steam penetration. The test does not necessarily demonstrate either achievement of the required temperature or maintenance of that temperature for the required time to achieve sterilization. A test pack for the Bowie and Dick test consists of two components: a) a s

38、mall standardized test load; b) a chemical indicator system to detect the presence of steam. The Bowie and Dick test as originally described 1utilized huckaback towels as the material for the test load. The test as described in EN 285 uses cotton sheets for this purpose. Indicators intended as an al

39、ternative to the Bowie and Dick test use different materials for the test load and employ indicator systems specifically formulated for use with the defined test load. Because a range of different tests in different countries have historically been termed the Bowie and Dick test, the term “Bowie and

40、 Dick-type test” is used in this part of ISO 11140. This part of ISO 11140 specifies the performance of the indicator system in combination with the test load with which it is intended to be used. The test load may be presented with the indicator system already incorporated and intended for single u

41、se, or it may be intended for multiple use with a new indicator system to be inserted prior to each use. The indicator for which the performance is specified in this part of ISO 11140 is intended to indicate when steam penetration has been inadequate. The performance of the indicator specified in th

42、is part of ISO 11140 should be equivalent, but not necessarily identical, to the performance obtained in the Bowie and Dick-type test as described in ISO 11140-3. Equivalence should be regarded as providing a similar response to steam penetration with any differences being predictable and such that

43、the necessary level of assurance of satisfactory steam penetration is provided. An indicator meeting this specification is not intended to identify which of the potential causes of poor steam penetration was responsible for the failure indicated by the test. EN ISO 11140-4:2007blank1Sterilization of

44、 health care products Chemical indicators Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration 1 Scope This part of ISO 11140 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for

45、steam sterilizers for wrapped health care goods (instruments, etc., and porous loads). NOTE The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of steam sterilization processes. An indicator complying with this part of ISO 11140 incorporates a specified mater

46、ial which is used as a test load. This test load may, or may not, be re-usable. This part of ISO 11140 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in th

47、is part of ISO 11140 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140 does not include test methods to establish the suitability of these indicator systems for use in sterilizers in which the air removal

48、 stage does not include evacuation below atmospheric pressure. 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

49、 (including any amendments) applies. ISO 5-1, Photography Density measurements Part 1: Terms, symbols and notations ISO 5-3, Photography Density measurements Part 3: Spectral conditions ISO 5-4:1995, Photography Density measurements Part 4: Geometric conditions for reflection density ISO 187:1990, Paper, board and pulps Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples ISO 2248, Packaging Complete, filled transport packages Vertical impact te