ISO INTERNATIONAL STANDARD 21151 First edition 2020-05 In vitro diagnostic medical devices Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples Dispositifs médicaux de diagnostic in vitro - Exigences relatives aux protocoles d'harmonisation internationaux établissant la tracabiliteé métrologique des valeurs affectées aux étalons et aux échantillons humains Reference number IS0 21151:2020(E) ISO @ IS0 2020 IS0 21151:2020(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2020 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may below or Iso's member body in the country of the requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii @ IS0 2020 - All rights reserved