DIN EN ISO 15195-2004 Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195 2003) German version EN ISO 15195 2003《实验室医学 参考测量实验室要求》.pdf
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1、ICS 03.120.20; 11.100Laboratory medicineRequirements for reference measurement laboratories(ISO 15195 : 2003)English version of DIN EN ISO 15195Laboratoriumsmedizin Anforderungen an die Referenzmesslaboratorien (ISO 15195 : 2003)European Standard EN ISO 15195 : 2003 has the status of a DIN Standard.
2、National forewordThis standard has been published in accordance with a decision taken by CEN/TC 140 to adopt, withoutalteration, International Standard ISO 15195 as a European Standard.The responsible German body involved in its preparation was the Normenausschuss Medizin (MedicalStandards Committee
3、), Technical Committee Referenzsysteme.DIN EN ISO 17511 and DIN EN ISO 18153 are the standards corresponding to International StandardsISO 17511 and ISO 18153, respectively, referred to in clause 2 of the EN.National Annex NAStandards referred to(and not included in Normative references, Bibliograph
4、y and Annex ZA)DIN EN ISO 17511 In vitro diagnostic medical devices Measurement of quantities in biologicalsamples Metrological traceability of values assigned to calibrators and controlmaterials (ISO 17511 : 2003)DIN EN ISO 18153 In vitro diagnostic medical devices Measurement of quantities in biol
5、ogicalsamples Metrological traceability of assigned values for catalytic concentration ofenzymes in calibrators and control materials (ISO 18153 : 2003)DEUTSCHE NORM January 2004DIN EN ISO 15195 No part of this standard may be reproduced without the prior permission ofDIN Deutsches Institut fr Normu
6、ng e.V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).Normenausschuss Bauwesen (NABau) im DINEnglish price group 13www.din.dewww.beuth.de05.04 9549070Continued overleaf.Document comprises 17 pages.English versionICS 11.100Manageme
7、nt Centre: rue de Stassart 36, B-1050 BrusselsEuropean Committee for StandardizationComit Europen de NormalisationEuropisches Komitee fr NormungLaboratory medicineRequirements for reference measurement laboratories(ISO 15195 : 2003) 2003. CEN All rights of exploitation in any form and by any meansre
8、served worldwide for CEN national members.Ref. No. EN ISO 15195 : 2003 EMdecine de laboratoires Exi-gences pur les laboratoires ralisantdes mesurages de rfrence(ISO 15195 : 2003)Laboratoriumsmedizin Anforderun-gen an die Referenzmess-laboratorien (ISO 15195 : 2003)This European Standard was approved
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