ISO INTERNATIONAL STANDARD 18153 First edition 2003-08-15 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials Dispositifs medicaux de diagnostic in vitroMesurage des grandeurs dans des échantillons d'origine biologique - Tracabilite metrologique des valeurs de concentration catalytique des enzymes attribuees aux agents d'etalonnage et aux materiaux de controle Reference number ISO 18153:2003(E) ISO @ ISO 2003 No reproduction or networking permited without license from IHS Not for Resale ISO 18153:2003(E) PDF disclaimer shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer perfoming the editing. In accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by Iso member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IsO at the address below or iSO's memberbody in thecountry oftherequester. ISO copyright office Case postale 56 : CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax +4122749 0947 E-mail [email protected] Web www.iso.org Published in Switzerland n for Standardization @ ISO 2003 - All rights reserved Provided by IHS under license with ISO Not for Resale ISO 18153:2003(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeen non-governmental, in liaison with IsO, also take part in the work. Iso collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/lEC Directives, Part 2. adopted by the technical committees are circulated to the member bodies for voting. Publication as ar International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in Standard...". For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council Directives has been removed. Standardiallinghts reserved ili Not for Resale ISO 18153:2003(E) Contents page Foreword, Introduction 1 Scope, 2 Normative references... 3 Termsand definitions, 4 Metrological traceability chain and calibration hierarchy .. 4.1 Principles...... 4.2 Structure... 5 Validation of metrologically traceable calibration... 5.1 Principles... 5.2 Analyticalspecificityofmeasurementprocedures.. 5.3 Commutability of calibrators .... 5.4 Commutability of control materials. Annex A (informative) List of IFcC primary reference measurement procedures Annex B (informative) List of certified reference materials (CRM). Bibliography 10 @ ISO 2003 - All rights reserved ed by IHS unc Not for Resale ISO18153:2003(E) Foreword medical devices", the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 212 "Cli