1、ICS 11.100In-vitro-Diagnostika Messung von Gren in Proben biologischen Ursprungs MetrologischeRckfhrbarkeit von Werten der katalytischen Konzentration von Enzymen, die Kalibratoren undKalibriermaterialien zugeordnet sind (ISO 18153 : 2003)European Standard EN ISO 18153 : 2003 has the status of a DIN
2、 Standard.A comma is used as the decimal marker.National forewordThis standard has been published in accordance with a decision taken by CEN/TC 140 to adopt, withoutalteration, International Standard ISO 18153 as a European Standard.The responsible German body involved in its preparation was the Nor
3、menausschuss Medizin (MedicalStandards Committee), Technical Committee Referenzsysteme.Ref. No. DIN EN ISO 18153 : 2003-11English price group 11 Sales No. 111103.04DEUTSCHE NORM November 2003EN ISO 18153Continued overleaf.EN comprises 15 pages. No part of this standard may be reproduced without the
4、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).In vitro diagnostic medical devicesMeasurement of quantities in biological samples Metrologicaltraceability of values for cat
5、alytic concentration of enzymes assignedto calibrators and control materials (ISO 18153 : 2003)English version of DIN EN ISO 18153ICS 07.100.10Descriptors: 2003. CEN All rights of exploitation in any form and by any meansreserved worldwide for CEN national members.Ref. No. EN ISO 18153 : 2003 EEN IS
6、O 18153August 2003Management Centre: rue de Stassart 36, B-1050 BrusselsEuropean Committee for StandardizationComit Europen de NormalisationEuropisches Komitee fr Normung|English versionIn vitro diagnostic medical devicesMeasurement of quantities in biological samples Metrologicaltraceability of val
7、ues for catalytic concentration of enzymes assigned tocalibrators and control materials(ISO 18153 : 2003)In-vitro-Diagnostika Messung vonGren in Proben biologischen Ur-sprungs Metrologische Rckfhr-barkeit von Werten der katalytischenKonzentration von Enzymen, dieKalibratoren und Kontrollmaterialienz
8、ugeordnet sind (ISO 18153 : 2003)This European Standard was approved by CEN on 2003-03-11.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
9、 and bibliographical references 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 responsibili
10、ty of aCEN member into its 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, the CzechRepublic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,Italy, Luxembourg, Malt
11、a, the Netherlands, Norway, Portugal, Slovakia, Spain,Sweden, Switzerland, and the United Kingdom.Dispositifs mdicaux de diagnostic invitro Mesurage des grandeurs dansdes chantillons dorigine biologique Traabilit mtrologique des valeurs deconcentration catalytique des enzymesattribues aux agents dta
12、lonnage etaux matriaux de contrle(ISO 18153 : 2003)Page 2EN ISO 18153 : 2003Page235557781010101111121314Page 3EN ISO 18153 : 2003Page 4EN ISO 18153 : 2003Page 5EN ISO 18153 : 2003Page 6EN ISO 18153 : 2003Page 7EN ISO 18153 : 2003Page 8EN ISO 18153 : 2003Page 9EN ISO 18153 : 2003Page 10EN ISO 18153 : 2003Page 11EN ISO 18153 : 2003Page 12EN ISO 18153 : 2003Page 13EN ISO 18153 : 2003Page 14EN ISO 18153 : 2003Page 15EN ISO 18153 : 2003
