EN ISO 11140-3-2009 en Sterilization of health care products - Chemical indicators - Part 3 Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test《卫生保健.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)This 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 publicationDate CommentsBS EN ISO 11140-3:2009National forewordThis British Standard is the UK implementatio

3、n 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 It is identical to ISO 11140-3:2007supersedes BS EN ISO 11140-3:2007 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations represented on this committee can b

4、e 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 British Standard cannot confer immunity from legal obligations.:2007. It , including Cor 1EUROPEAN STAND

5、ARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11140-3May 2009ICS 11.080.01 Supersedes EN ISO 11140-3:2007 English 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

6、:2007)Strilisation des produits de sant - Indicateurs chimiques -Partie 3: Systmes dindicateurs de Classe 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 - Tei

7、l 3: Indikatorsysteme derKlasse 2 zur Verwendung im Bowie-Dick-Dampfdurchdringungstest (ISO 11140-3:2007,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 g

8、iving 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 official ver

9、sions (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, Belgium,

10、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 STANDAR

11、DIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, 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: EBS EN ISO 11140-3:2009EN ISO 11140-3:200

12、9 (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

13、 “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 endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn at

14、 the 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

15、 has 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 c

16、onsists 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 D

17、ick-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 dec

18、ided 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

19、ISO 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 organi

20、zations 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, Rom

21、ania, 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. BS EN ISO 11140-3:2009EN ISO 11140-3:2009 (E) 4 Annex ZA (informative) Relati

22、onship 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 European Free Trade Association to provide a means of conforming to Essential Requirements of the Ne

23、w 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 at least one Member State, compliance with the clauses of this standard given in Table ZA confers

24、, 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 between this European Standard and Directive 93/42/EEC on medical devices WARNING Other requirements

25、 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 remarks/Notes4.1 5, 8, 7, 13 The requirements of ISO 11140-1 apply 6 7.1 7 13 except 13.3 a) and 13

26、.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 BS EN ISO 11140-3:2009ISO 11140-3:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 No

27、rmative references . 1 3 Terms and definitions. 2 4 General requirements. 2 5 Indicator system format . 2 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 vis

28、ual difference between colour of the substrate and the changed (or unchanged) indicator system by determination 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 c

29、hange on exposure to dry heat 11 Annex E (normative) Accelerated ageing of test samples. 12 Annex F (normative) 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 apparat

30、us. 15 Annex I (normative) Determination of sensitivity of the indicator to the presence of air 17 Annex J (normative) Air injection system . 18 Annex K (normative) Standard test pack. 20 Bibliography . 21 BS EN ISO 11140-3:2009ISO 11140-3:2007(E) iv ISO 2007 All rights reservedForeword ISO (the Int

31、ernational 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 ha

32、s 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 Commission (IEC) on all matters of electrotechnical

33、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 committees are circulated to the member bodie

34、s 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 not be held responsible for identifying any o

35、r all 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

36、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 penetration Pa

37、rt 5: Class 2 indicators for Bowie and Dick-type air removal tests BS 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 sterilizers for wrapped goods and porous loads. As such it is performed during the demonstra

38、tion 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 of potential problems with the sterilizer that could compromise the uniform sterilization of

39、 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 causes of failure. The Bowie and Dick test was conceived as a test for successful air removal from

40、 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 air within the pack, due to an inefficient air removal stage, an air leak during this stage or

41、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 not necessarily demonstrate either achievement of the required temperature or maintenance of

42、 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 presence of steam. The Bowie and Dick test as originally described 1utilized huckaback towels

43、 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 Dick test, the term “Bowie and Dick-type test” is used in this part of ISO 11140. BS EN ISO 11

44、140-3:2009BS 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

45、requirements 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 intend

46、ed for use 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

47、 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 Part 1: Terms, symbols and notations ISO 5-3, Photography Densi

48、ty 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

49、 ISO 2248, Packaging Complete, filled transport packages Vertical impact test by dropping ISO 5457, Technical product documentation Sizes and layout of drawing sheets ISO 5636-3, Paper and board Determination of air permeance (medium range) Part 3: Bendtsen method ISO 11140-1:2005, Sterilization of health care products Chemical indicators Part 1: General requirements ISO/CIE 10526:1999, CIE standard illuminants for colorimetry EN 285:2006, Sterilization Steam sterilizers Large sterilizers BS EN