1、ICS 11.100In-vitro-Diagnostika Messung von Gren in Proben biologischen Ursprungs MetrologischeRckfhrbarkeit von Werten, die Kalibriermaterialien und Kontrollmaterialien zugeordnet sind(ISO 17511 : 2003)European Standard EN ISO 17511 : 2003 has the status of a DIN Standard.A comma is used as the deci
2、mal marker.National forewordThis standard has been published in accordance with a decision taken by CEN/TC 140 to adopt, withoutalteration, International Standard ISO 17511 as a European Standard.The responsible German body involved in its preparation was the Normenausschuss Medizin (MedicalStandard
3、s Committee), Technical Committee Referenzsysteme.Ref. No. DIN EN ISO 17511 : 2003-11English price group 15 Sales No. 111503.04DEUTSCHE NORM November 2003EN ISO 17511Continued overleaf.EN comprises 29 pages. No part of this standard may be reproduced without the prior permission ofDIN Deutsches Inst
4、itut 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 assigned to calibrators and controlmaterials
5、 (ISO 17511 : 2003)English version of DIN EN ISO 17511English versionICS 07.100.10Descriptors:In vitro diagnostic medical devicesMeasurement of quantities in biological samples Metrologicaltraceability of values assigned to calibrators and control materials(ISO 17511 : 2003) 2003. CEN All rights of
6、exploitation in any form and by any meansreserved worldwide for CEN national members.Ref. No. EN ISO 17511 : 2003 EIn-vitro-Diagnostika Messung vonGren in Proben biologischen Ur-sprungs Metrologische Rckfhr-barkeit von Werten, die Kalibrier-materialien und Kontrollmaterialienzugeordnet sind (ISO 175
7、11 : 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 and bibliographical re
8、ferences 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
9、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, Malta, the Netherlands, Nor
10、way, Portugal, Slovakia, Spain,Sweden, Switzerland, and the United Kingdom.EN ISO 17511August 2003Management Centre: rue de Stassart 36, B-1050 BrusselsEuropean Committee for StandardizationComit Europen de NormalisationEuropisches Komitee fr Normung|Dispositifs mdicaux de diagnostic invitro Mesurag
11、e des grandeurs dansdes chantillons dorigine biologique Traabilit mtrologique des valeursattribues aux agents dtalonnage etaux matriaux de contrle(ISO 17511 : 2003)Page 2EN ISO 17511 : 2003Page346661212131718181819202122232424252627Page 3EN ISO 17511 : 2003Page 4EN ISO 17511 : 2003Page 5EN ISO 17511
12、 : 2003Page 6EN ISO 17511 : 2003Page 7EN ISO 17511 : 2003Page 8EN ISO 17511 : 2003Page 9EN ISO 17511 : 2003Page 10EN ISO 17511 : 2003Page 11EN ISO 17511 : 2003Page 12EN ISO 17511 : 2003Page 13EN ISO 17511 : 2003Page 14EN ISO 17511 : 2003Page 15EN ISO 17511 : 2003Page 16EN ISO 17511 : 2003Page 17EN I
13、SO 17511 : 2003Page 18EN ISO 17511 : 2003Page 19EN ISO 17511 : 2003Page 20EN ISO 17511 : 2003Page 21EN ISO 17511 : 2003Page 22EN ISO 17511 : 2003Page 23EN ISO 17511 : 2003Page 24EN ISO 17511 : 2003Page 25EN ISO 17511 : 2003Page 26EN ISO 17511 : 2003Page 27EN ISO 17511 : 2003Page 28EN ISO 17511 : 2003
