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

9、 by CEN on 2003-07-24.CEN members are bound to comply with the CEN/CENELEC InternalRegulations which stipulate the conditions for giving this European Standardthe status of a national standard without any alteration.Up-to-date lists and bibliographical references concerning such nationalstandards ma

10、y 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 theresponsibility of a CEN member into its own language and notified to theManagement

11、Centre has the 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, Norway, Portugal, Slovakia,Spain, Sweden, Switzerl

12、and, and the United Kingdom.|October 2003EN ISO 15195Page 2EN ISO 15195 : 2003ForewordInternational StandardISO 15195 : 2003 Laboratory medicine Requirements for reference measurement laboratories,which was prepared by ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems of th

13、eInternational Organization for Standardization, has been adopted by Technical Committee CEN/TC 140 In vitrodiagnostic medical devices, the Secretariat of which is held by DIN, as a European Standard.This European Standard shall be given the status of a national standard, either by publication of an

14、 identical textor by endorsement, and conflicting national standards withdrawn, by April 2004 at the latest.In accordance with the CEN/CENELEC Internal Regulations, the national standards organizations of thefollowing countries are bound to implement this European Standard:Austria, Belgium, the Czec

15、h Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,Italy, Luxembourg, Malta, the Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland, and theUnited Kingdom.Endorsement noticeThe text of the International Standard ISO 15195 : 2003 was approved by CEN as a

16、 European Standard with-out any modification.NOTE: Normative references to international publications are listed in Annex ZA (normative).235568891010101111111112121213131415Page 3EN ISO 15195 : 2003Page 4EN ISO 15195 : 2003Page 5EN ISO 15195 : 2003Page 6EN ISO 15195 : 2003Page 7EN ISO 15195 : 2003Page 8EN ISO 15195 : 2003Page 9EN ISO 15195 : 2003Page 10EN ISO 15195 : 2003Page 11EN ISO 15195 : 2003Page 12EN ISO 15195 : 2003Page 13EN ISO 15195 : 2003Page 14EN ISO 15195 : 2003Page 15EN ISO 15195 : 2003Page 16EN ISO 15195 : 2003