DIN EN 867-5-2001 Non-biological systems for use in sterilizers - Part 5 Specification for indicator systems and process challenge devices for use in performance testing for small .pdf

1、ICS 11.080.10Nichtbiologische Systeme fr den Gebrauch in Sterilisatoren Teil 5: Festlegungen von Indikatorsystemenund Prfkrpern fr die Leistungsprfung von Klein-Sterilisatoren vom Typ B und vom Typ SEuropean Standard EN 867-5 : 2001 has the status of a DIN Standard.A comma is used as the decimal mar

2、ker.National forewordThis standard has been prepared by CEN/TC 102 Sterilizers for medical purposes.The responsible German body involved in its preparation was the Normenausschuss Medizin (MedicalStandards Committee), Technical Committee Indikatoren.DIN ISO 3696 and DIN ISO 10012-1 are the standards

3、 corresponding to International StandardsEN ISO 3696 and ISO 10012-1, respectively, referred to in clause 2 of the EN.Ref. No. DIN EN 867-5 : 2001-11English price group 13 Sales No. 111303.02DEUTSCHE NORM November 2001EN 867-5Continued overleaf.EN comprises 23 pages. No part of this standard may be

4、reproduced without the 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).Non-biological systems for use in sterilizersPart 5: Specification for indicator systems and process c

5、hallengedevices for use in performance testing for small sterilizersof type B and type SEnglish version of DIN EN 867-5ICS 11.080.10Descriptors: 2001. CEN All rights of exploitation in any form and by any meansreserved worldwide for CEN national members.Ref. No. EN 867-5 : 2001 EEN 867-5August 2001M

6、anagement Centre: rue de Stassart 36, B-1050 BrusselsEuropean Committee for StandardizationComit Europen de NormalisationEuropisches Komitee fr Normung|English versionNon-biological systems for use in sterilizersPart 5: Specification for indicator systems and process challengedevices for use in perf

7、ormance testing for small sterilizersof type B and type SNichtbiologische Systeme fr denGebrauch in Sterilisatoren Teil 5:Festlegungen von Indikatorsystemenund Prfkrpern fr die Leistungspr-fung von Klein-Sterilisatoren vom TypB und vom Typ SThis European Standard was approved by CEN on 2001-07-25.CE

8、N members are bound to comply with the CEN/CENELEC Internal Regulationswhich stipulate the conditions for giving this European Standard the status of anational standard without any alteration.Up-to-date lists and bibliographical references concerning such national stand-ards may be obtained on appli

9、cation to the Management Centre or to anyCEN member.The European Standards exist in three official versions (English, French, German).A version in any other language made by translation under the responsibility of aCEN member into its own language and notified to the Management Centre hasthe same st

10、atus as the official versions.CEN members are the national standards bodies of Austria, Belgium, the CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland,and the United Kingdom.Systmes non biologiq

11、ues destins tre utiliss dans des strilisateurs Partie 5: Spcifications des systmesindicateurs et dispositifs dpreuve deprocd destins tre utiliss pourles essais de performances relatifsaux petits strilisateurs de type B etde type SPage 2EN 867-5 : 2001PagePage 3EN 867-5 : 2001Page 4EN 867-5 : 2001Pag

12、e 5EN 867-5 : 2001Page 6EN 867-5 : 2001Page 7EN 867-5 : 2001Page 8EN 867-5 : 2001Page 9EN 867-5 : 2001Page 10EN 867-5 : 2001Page 11EN 867-5 : 2001Page 12EN 867-5 : 2001Page 13EN 867-5 : 2001Page 14EN 867-5 : 2001Page 15EN 867-5 : 2001Page 16EN 867-5 : 2001Page 17EN 867-5 : 2001Page 18EN 867-5 : 2001Page 19EN 867-5 : 2001Page 20EN 867-5 : 2001Page 21EN 867-5 : 2001Page 22EN 867-5 : 2001Page 23EN 867-5 : 2001