BS EN ISO 11140-3-2009 Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test《保健品灭菌 化学指示剂.pdf

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1、BS EN ISO11140-3:2009ICS 11.080.01NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterilization of healthcare products Chemical indicatorsPart 3: Class 2 indicator systems foruse in the Bowie and Dick-type steampenetration test (ISO 11140-3:2007,including Cor 1:

2、2007)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 02:06, Uncontrolled Copy, (c) BSIThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 31January 2010. BSI 2010ISBN 978 0 580 65848 8Amendments/corrigenda issued since publicati

3、onDate CommentsBS EN ISO 11140-3:2009National forewordThis British Standard is the UK implementation of EN ISO 11140-3: 2009. It is identical to ISO 11140-3:2007supersedes BS EN ISO 11140-3:2007 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee LBI/35, S

4、terilizers, autoclaves and disinfectors.A list of organizations represented on this committee 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 with a Briti

5、sh Standard cannot confer immunity from legal obligations.:2007. It , including Cor 1Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 02:06, Uncontrolled Copy, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11140-3May 2009ICS 11.080.01 Supersedes EN ISO 11140-3:2007 En

6、glish VersionSterilization of health care products - Chemical indicators - Part3: Class 2 indicator systems for use in the Bowie and Dick-typesteam penetration test (ISO 11140-3:2007, including Cor1:2007)Strilisation des produits de sant - Indicateurs chimiques -Partie 3: Systmes dindicateurs de Cla

7、sse 2 pourutilisation lors de lessai de Bowie et Dick de pntration dela vapeur (ISO 11140-3:2007, Cor 1:2007 inclus)Sterilisation von Produkten fr die Gesundheitsfrsorge -Chemische Indikatoren - Teil 3: Indikatorsysteme derKlasse 2 zur Verwendung im Bowie-Dick-Dampfdurchdringungstest (ISO 11140-3:20

8、07,einschlielich Cor 1:2007)This European Standard was approved by CEN on 19 April 2009.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

9、 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 official versions (English, French, German). A version in any other language made by translationunder the responsi

10、bility 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, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland,

11、 Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 1

12、7, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11140-3:2009: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 02:06, Uncontrolled Copy, (c) BSIBS EN ISO 11140-3:2009EN ISO 11140-3:2009 (

13、E) 3 Foreword The text of ISO 11140-3:2007, including Cor 1:2007 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11140-3:2009 by Technical Committee CEN/TC 102 “S

14、terilizers 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 endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn at th

15、e 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 CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11140-3:2007. This document ha

16、s been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. The series EN ISO 11140 cons

17、ists of the following parts under 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

18、-type test for detection of steam 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 decide

19、d not to adopt ISO 11140-5 as a European 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

20、 15882 Sterilization of health care 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 organizat

21、ions of the following countries are 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, Romani

22、a, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 11140-3:2007, including Cor 1:2007 has been approved by CEN as a EN ISO 11140-3:2009 without any modification. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 02:06, Uncontr

23、olled Copy, (c) BSIBS EN ISO 11140-3:2009EN ISO 11140-3:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the Euro

24、pean Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in a

25、t least one Member State, compliance with the clauses of this standard given in Table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA Correspondence betw

26、een this European Standard and Directive 93/42/EEC on medical devices WARNING Other requirements and other EU-directives may be applicable to the product(s) falling within the scope of the standard. Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying rem

27、arks/Notes4.1 5, 8, 7, 13 The requirements of ISO 11140-1 apply 6 7.1 7 13 except 13.3 a) and 13.6 q) The relevant Essential Requirement 13.3a) is partly addressed. The relevant Essential Requirement 13.q) is not addressed in this European Standard 7.4 7.1 8.1 7.1 Licensed Copy: Wang Bin, ISO/EXCHAN

28、GE CHINA STANDARDS, 01/04/2010 02:06, Uncontrolled Copy, (c) BSIBS EN ISO 11140-3:2009ISO 11140-3:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements. 2 5 Indicator system format . 2

29、 6 Performance requirements 2 7 Packaging and labelling. 3 8 Quality assurance. 4 Annex A (normative) Determination of strength after steam sterilization . 5 Annex B (normative) Estimation of visual difference between colour of the substrate and the changed (or unchanged) indicator system by determi

30、nation of relative reflectance density 6 Annex C (normative) Determination of indicator colour change on exposure to dry saturated steam 10 Annex D (normative) Determination of indicator colour change on exposure to dry heat 11 Annex E (normative) Accelerated ageing of test samples. 12 Annex F (norm

31、ative) Determination of transfer of indicator to standard test pack on processing 13 Annex G (normative) Determination of shelf life of the product . 14 Annex H (normative) Steam exposure apparatus. 15 Annex I (normative) Determination of sensitivity of the indicator to the presence of air 17 Annex

32、J (normative) Air injection system . 18 Annex K (normative) Standard test pack. 20 Bibliography . 21 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 02:06, Uncontrolled Copy, (c) BSIBS EN ISO 11140-3:2009ISO 11140-3:2007(E) iv ISO 2007 All rights reservedForeword ISO (the Internati

33、onal 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 subject for which a technical committee has been

34、 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 Commission (IEC) on all matters of electrotechnical standa

35、rdization. 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 committees are circulated to the member bodies for

36、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 not be held responsible for identifying any or all

37、such patent rights. ISO 11140-3 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 11140-3:2000) which has been technically revised. ISO 11140 consists of the following parts, under the general title

38、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 penetration Part 5:

39、Class 2 indicators for Bowie and Dick-type air removal tests Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 02:06, Uncontrolled Copy, (c) BSIBS EN ISO 11140-3:2009ISO 11140-3:2007(E) ISO 2007 All rights reserved vIntroduction The Bowie and Dick test is a performance test for steam

40、 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 285. A failure of the Bowie and Dick test is symptomatic of a number

41、 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-condensable gases and it can be necessary to investigate other cause

42、s 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 and even penetration of steam into the test pack. The presence of ai

43、r within the pack, due to an inefficient air removal stage, an air leak during this stage or non-condensable gases in the steam supply, is a circumstance which can lead to failure of the test. The result of the test may also be affected by other factors which inhibit steam penetration. The test does

44、 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 small standardized test load; b) a chemical indicator to detect the

45、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. Because a range of different tests in different countries has historically been termed the Bowie and D

46、ick test, the term “Bowie and Dick-type test” is used in this part of ISO 11140. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 02:06, Uncontrolled Copy, (c) BSIBS EN ISO 11140-3:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 01/04/2010 02:06, Uncontrolled Copy, (c) BS

47、IBS EN ISO 11140-3:2009INTERNATIONAL STANDARD ISO 11140-3:2007(E) ISO 2007 All rights reserved 1Sterilization of health care products Chemical indicators Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test 1 Scope This part of ISO 11140 specifies the requireme

48、nts for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Indicators complying with this part of ISO 11140 are intended for us

49、e in combination with the standard test pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems. 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 any amendments) applies. ISO 5-1, Photography Density measurements