DIN EN 14136-2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures German version EN 14136 2004《体外诊断检验程.pdf

1、ICS 11.100Use of external quality assessment schemes in the assessment ofthe performance of in vitro diagnostic examination proceduresEnglish version of DIN EN 14136Verwendung externer Qualittssicherungsprogramme bei der Bewertung der Durchfhrung von Unter-suchungsverfahren in der In-vitro-Diagnosti

2、kEuropean Standard EN 14136 : 2004 has the status of a DIN Standard.A comma is used as the decimal marker.National forewordThis standard has been prepared by CEN/TC 140 In vitro diagnostic medical devices (Secretariat: Ger-many).The responsible German body involved in its preparation was the Normena

3、usschuss Medizin (MedicalStandards Committee), Technical Committee Qualittsmanagement in medizinischen Laboratorien.DEUTSCHE NORM August 2004DIN EN 14136 No part of this standard may be reproduced without the prior permission ofDIN Deutsches Institut fr Normung e.V., Berlin. Beuth Verlag GmbH, 10772

4、 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).English price group 10www.din.dewww.beuth.de9587856Continued overleaf.Document comprises 11 pages.11.04English versionICS 11.100Use of external quality assessment schemes in the assessment ofthe performance of in vitr

5、o diagnostic examination procedures 2004. CEN All rights of exploitation in any form and by any meansreserved worldwide for CEN national members.Ref. No. EN 14136 : 2004 EVerwendung externer Qualittssiche-rungsprogramme bei der Bewertungder Durchfhrung von Untersuchungs-verfahren in der In-vitro-Dia

6、gnostikThis European Standard was approved by CEN on 2004-03-02.CEN 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 refer

7、ences concerning such national stand-ards may be obtained on application 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

8、 own language and notified to the Management Centre hasthe same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, theCzech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Luxemb

9、ourg, Malta, the Netherlands,Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, andthe United Kingdom.EN 14136May 2004Management Centre: rue de Stassart 36, B-1050 BrusselsEuropean Committee for StandardizationComit Europen de NormalisationEuropisches Komitee fr NormungUtilisa

10、tion des programmes dvalua-tion externe de la qualit dans lva-luation de la performance des proc-dures de diagnostic in vitroPage 2EN 14136 : 2004Page 3EN 14136 : 2004Page 4EN 14136 : 2004Page 5EN 14136 : 2004Page 6EN 14136 : 2004Page 7EN 14136 : 2004Page 8EN 14136 : 2004Page 9EN 14136 : 2004Page 10EN 14136 : 2004