EN 13727-2012 en Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirement.pdf
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1、BSI Standards PublicationBS EN 13727:2012+A2:2015Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity in the medical area Test method and requirements (phase 2, step 1)BS EN 13727:2012+A1:2013BS EN 13727:2012+A2:2015 BRITISH STANDARDNational
2、 forewordThis British Standard is the UK implementation of EN 13727:2012+A2:2015. It supersedes BS EN 13727:2012+A1:2013 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to CEN text carry the number of the CE
3、N amendment. For example, text altered by CEN amendment A1 is indicated by .The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on this committee can be obtained on request to its secretary.Th
4、is publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 89232 5ICS 11.080.20Compliance with a British Standard cannot confer
5、 immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012.Amendments/corrigenda issued since publicationDate Text affected28 February 2014 Implementation of CEN amendment A1:201330 November 2015 Implemen
6、tation of CEN amendment A2:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13727:2012+A2 October 2015 ICS 11.080.20 Supersedes EN 13727:2012+A1:2013English Version Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medica
7、l area - Test method and requirements (phase 2, step 1) Antiseptiques et dsinfectants chimiques - Essai quantitatif de suspension pour lvaluation de lactivit bactricide en mdecine - Mthode dessai et prescriptions (Phase 2, tape 1) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspens
8、ionsversuch zur Bestimmung der bakteriziden Wirkung im humanmedizinischen Bereich - Prfverfahren und Anforderungen (Phase 2, Stufe 1)This European Standard was approved by CEN on 14 October 2013 and includes Amendment 2 approved by CEN on 3 August 2015. CEN members are bound to comply with the CEN/C
9、ENELEC Internal 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-CENELEC Management Centr
10、e or to any CEN member. 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-CENELEC Management Centre has the same status as the
11、official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherla
12、nds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights
13、 of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13727:2012+A2:2015 EEN 13727:2012+A2:2015 (E) 2 Contents Page European foreword . 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Requirements . 6 5 Test method 8
14、5.1 Principle . 8 5.2 Materials and reagents 8 5.2.1 Test organisms . 8 5.2.2 Culture media and reagents 9 5.3 Apparatus and glassware 11 5.3.1 General . 11 5.3.2 Usual microbiological laboratory equipment 12 5.4 Preparation of test organism suspensions and product test solutions 13 5.4.1 Test organ
15、ism suspensions (test and validation suspension) . 13 5.4.2 Product test solutions . 15 5.5 Procedure for assessing the bactericidal activity of the product . 15 5.5.1 General . 15 5.5.2 Dilution-neutralization method 17 5.5.3 Membrane filtration method . 19 5.5.4 Modified method for ready-to-use pr
16、oducts 21 5.6 Experimental data and calculation 23 5.6.1 Explanation of terms and abbreviations . 23 5.6.2 Calculation 23 5.7 Verification of methodology . 28 5.7.1 General . 28 5.7.2 Control of weighted mean counts . 28 5.7.3 Basic limits . 29 5.8 Expression of results and precision 29 5.8.1 Reduct
17、ion 29 5.8.2 Control of active and non-active product test solution (5.4.2) . 29 5.8.3 Limiting test organism and bactericidal concentration . 30 5.8.4 Precision, repetitions . 30 5.9 Interpretation of results - conclusion . 30 5.9.1 General . 30 5.9.2 Bactericidal activity for handrub and handwash
18、products 30 5.9.3 Bactericidal activity for instrument disinfection products 30 5.9.4 Bactericidal activity for surface disinfection products 31 5.9.5 Qualification for certain fields of application 31 5.10 Test report 31 Annex A (informative) Referenced strains in national collections . 33 Annex B
19、(informative) Neutralizers and rinsing liquids . 34 BS EN 13727:2012+A2:2015EN 13727:2012+A2:2015 (E) 2 Contents Page European foreword . 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Requirements . 6 5 Test method 8 5.1 Principle . 8 5.2 Materials and reagents 8
20、5.2.1 Test organisms . 8 5.2.2 Culture media and reagents 9 5.3 Apparatus and glassware 11 5.3.1 General . 11 5.3.2 Usual microbiological laboratory equipment 12 5.4 Preparation of test organism suspensions and product test solutions 13 5.4.1 Test organism suspensions (test and validation suspension
21、) . 13 5.4.2 Product test solutions . 15 5.5 Procedure for assessing the bactericidal activity of the product . 15 5.5.1 General . 15 5.5.2 Dilution-neutralization method 17 5.5.3 Membrane filtration method . 19 5.5.4 Modified method for ready-to-use products 21 5.6 Experimental data and calculation
22、 23 5.6.1 Explanation of terms and abbreviations . 23 5.6.2 Calculation 23 5.7 Verification of methodology . 28 5.7.1 General . 28 5.7.2 Control of weighted mean counts . 28 5.7.3 Basic limits . 29 5.8 Expression of results and precision 29 5.8.1 Reduction 29 5.8.2 Control of active and non-active p
23、roduct test solution (5.4.2) . 29 5.8.3 Limiting test organism and bactericidal concentration . 30 5.8.4 Precision, repetitions . 30 5.9 Interpretation of results - conclusion . 30 5.9.1 General . 30 5.9.2 Bactericidal activity for handrub and handwash products 30 5.9.3 Bactericidal activity for ins
24、trument disinfection products 30 5.9.4 Bactericidal activity for surface disinfection products 31 5.9.5 Qualification for certain fields of application 31 5.10 Test report 31 Annex A (informative) Referenced strains in national collections . 33 Annex B (informative) Neutralizers and rinsing liquids
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