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
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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
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