DIN EN ISO 11140-3-2009 Sterilization of health care products - Chemical indicators - Part 3 Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (IS.pdf

1、September 2009DEUTSCHE NORM English price group 14No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.080.20!$Ybj“15463

2、71www.din.deDDIN EN ISO 11140-3Sterilization of health care products Chemical indicators Part 3: Class 2 indicator systems for use in the Bowie and Dick-typeEnglish version of DIN EN ISO 11140-3:2009-09Sterilisation von Produkten fr die Gesundheitsfrsorge Chemische Indikatoren Teil 3: Indikatorsyste

3、me der Klasse 2 zur Verwendung imEnglische Fassung DIN EN ISO 11140-3:2009-09SupersedesDIN EN ISO 11140-3:2007-07andDIN EN ISO 11140-3Corrigendum 1:2008-12See start of validitywww.beuth.deDocument comprises 30 pages.Bowie-Dick-Dampfdurchdringungstest (ISO 11140-3:2007, einschlielich Cor 1:2007)steam

4、 penetration test (ISO 11140-3:2007, including Cor 1:2007)DIN EN ISO 11140-3:2009-09 2 Start of validity This standard takes effect on 1 September 2009. DIN EN ISO 11140-3:2007-07 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committee IS

5、O/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Commi

6、ttee NA 063-04-08 AA Indikatoren. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. DIN EN ISO 11140 consists of the following parts under the general title Sterilization of health care products Chemical indicators: Part 1:

7、 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 6: Class 2 indicators and process challenge devices for use in perfor

8、mance testing for small steam sterilizers (under preparation) The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 187 DIN EN 20187 ISO 2248 DIN EN 22248 ISO 5457 DIN EN ISO 5457 ISO 9001 DIN EN ISO 9001 ISO 11140-1 DIN EN ISO 11140-1 ISO 15

9、882 DIN EN ISO 15882 ISO 17665-1 DIN EN ISO 17665-1 Amendments This standard differs from DIN EN ISO 11140-3:2007-07 and DIN EN ISO 11140-3 Corrigendum 1:2008-12 as follows: a) Corrigendum 1 has been incorporated. b) Annex ZA (informative) concerning the relationship between this European Standard a

10、nd the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating

11、to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. DIN EN ISO 11140-3:2009-09 3 Previous editions DIN EN 867-3: 1997-05 DIN EN ISO 11140-3: 2007-07 DIN EN ISO 11140-3 Corrigendum 1: 2008-12 National Annex

12、 NA (informative) Bibliography DIN EN 20187, Paper, board and pulps Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples DIN EN 22248, Packaging Complete, filled transport packages Vertical impact test by dropping DIN EN ISO 5457, T

13、echnical product documentation Sizes and layout of drawing sheets DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 11140-1, Sterilization of health care products Chemical indicators Part 1: General requirements DIN EN ISO 15882, Sterilization of health care products Chemical indic

14、ators Guidance for selection, use and interpretation of results DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11140-3:2009-09 4 This page is inten

15、tionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11140-3 May 2009 ICS 11.080.01 Supersedes EN ISO 11140-3:2007 English Version Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration t

16、est (ISO 11140-3:2007, including Cor. 1:2007) Strilisation des produits de sant - Indicateurs chimiques -Partie 3: Systmes dindicateurs de Classe 2 pour utilisation lors de lessai de Bowie et Dick de pntration de la vapeur (ISO 11140-3:2007, Cor. 1:2007 inclus) Sterilisation von Produkten fr die Ges

17、undheitsfrsorge - Chemische Indikatoren - Teil 3: Indikatorsysteme der Klasse 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 Interna

18、l Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member

19、. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members

20、 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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Swit

21、zerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No.

22、 EN ISO 11140-3:2009: EContents Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 General requirements .6 5 Indicator system format6 6 Performance requirements.6 7 Packaging and labelling7 8 Quality assurance8 Annex A (normative) Determination of strength

23、after steam sterilization 9 Annex B (normative) Estimation of visual difference between colour of the substrate and the changed (or unchanged) indicator system by determination of relative reflectance density.10 Annex C (normative) Determination of indicator colour change on exposure to dry saturate

24、d steam 14 Annex D (normative) Determination of indicator colour change on exposure to dry heat.15 Annex E (normative) Accelerated ageing of test samples .16 Annex F (normative) Determination of transfer of indicator to standard test pack on processing.17 Annex G (normative) Determination of shelf l

25、ife of the product18 Annex H (normative) Steam exposure apparatus .19 Annex I (normative) Determination of sensitivity of the indicator to the presence of air .21 Annex J (normative) Air injection system22 Annex K (normative) Standard test pack .24 Bibliography25 Annex ZA (informative) Relationship

26、between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .26 2 DIN EN ISO 11140-3:2009-09 EN ISO 11140-3:2009 (E) Foreword 3 DIN EN ISO 11140-3:2009-09 EN ISO 11140-3:2009 (E) The text of ISO 11140-3:2007, including Cor. 1:2007 has been prepared by Technical Committee

27、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 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This European Standard shall be

28、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 the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document m

29、ay 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associ

30、ation, 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 consists of the following parts under the general title Sterilization of health care products Chemical indicat

31、ors: 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 Attention is drawn to the fact that the series ISO 11140 addit

32、ionally 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 European Standard. In addition, reference is made to EN 867-5 Non-biological

33、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 care products Chemical indicators Guidance for selection, use and interpretation

34、 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 are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus,

35、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 the United Kingdom. Endorsement notice without any modificati

36、on. The text of ISO 11140-3:2007, including Cor. 1:2007 has been approved by CEN as EN ISO 11140-3:2009Introduction 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 sterili

37、zers 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 a load to be processed. This failur

38、e 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 high-vacuum porous-load sterilizers

39、 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 non-condensable gases in the steam s

40、upply, 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 that temperature for the required t

41、ime 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 as the material for the test load.

42、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. 4 DIN EN ISO 11140-3:2009-09 EN ISO 11140-3:2009

43、 (E) N1)N1)National footnote: To differentiate clearly between the test described here and the alternative systems described in Part 4 of this standards series, the term “Bowie and Dick test” is used to refer to testing with a chemical indicator as part of a test pack, as described in this part of t

44、he series. 1 Scope This part of ISO 11140 specifies the 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. Ind

45、icators complying with this part of ISO 11140 are intended 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

46、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 Part 1:

47、 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 f

48、or monitoring the atmosphere and conditioning of samples 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) Par

49、t 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 5 DIN EN ISO 11140-3:2009-09 EN ISO 11140-3:2009 (E) 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11140-1 apply. 4 General requirements 4.1 The requirements of ISO 11140-1 a