ISO INTERNATIONAL STANDARD 17511 Second edition 2020-04 In vitro diagnostic medical devices Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples Dispositifs medicaux de diagnostic in vitro -Exigences pour I'établissement d'une tracabilite metrologique des valeurs attribuees aux étalons, aux matériaux de controle de la justesse et aux échantillonshumains Reference number IS0 17511:2020(E) Tso @ ISO 2020 IS0 17511:2020(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2020 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting below orIso's member body in the country of therequester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland i @IS0 2020 - All rights reserved IS0 17511:2020(E) Contents Page Foreword vi Introduction. ..viii 1 Scope. 1 2 Normativereferences .2 3 Terms and definitions, symbols and abbreviated terms .2 General requirements to be fulfilled by a manufacturer for establishing, validating 4 and documenting metrological traceability of human sample values determined with a specifiedIVDMD 19 4.1 Requirements for documenting metrological traceability of measured quantity values... 19 4.2 Definitionofthemeasurand 19 4.3 Specifications for maximum allowable expanded measurement uncertainty, Umax(y) 20 4.3.1 Generalreguirements 20 4.3.2 Scope ofthe specification 20 4.4 Defining the calibration hierarchy 20 4.4.1 General requirements 20 Measured quantity. 21 4.4.2 Highest level of metrological traceability .21 4.4.3 4.4.4 Traceability to SI 21 4.4.5 Non-SI traceable IVD MDs. 21 4.4.6 21 Number oflevels in the specified hierarchy 4.5 Selection and requirements for RMs and calibrators 21 4.5.1 General requirements. 21 4.5.2 Characteristics to be documented 21 4.5.3 Higher order RMs that conform with IS0 15194 22 22 4.5.4 RMs not conforming to ISO 15194 4.5.5 Commutability of RMs 22 4.5.6 Exceptionto commutabilityassessmentrequirements. 23 4.5.7 Application of a non-commutable CRM 23 4.5.8 Alternative RMs. 23 4.5.9 Augmentation ofalternative RMs. 23 4.5.10 24 Non-commutable end-userIVD MD calibrators Selection and requirements for MPs. 24 4.6 4.6.1 Rationaleforselectionof MPs and documentationresponsibility 24 4.6.2 Metrological status of MPs 24 4.6.3 Referencemeasurementlaboratories. 24 25 4.6.4 Impact of influencequantities 4.6.5 Changes in the measured quantity within a calibration hierarchy 25 25 4.7 Estimating uncertainty of assigned valuesfor end-user IVD MD calibrators 4.7.1 25 Generalrequirements 4.7.2 Documentation for method of estimating ucal 26 4.7.3 Statistical considerations and scope of ucal estimates 26 4.7.4 Expression of ucal 26 4.7.5 Productmodifications 27 4.7.6 Information to be provided to the end-user 28 4.8 Validation of metrological traceability of values assigned to an IVD MD calibrator 28 4.8.1 General validation requirements. 28 4.8.2 Validation strategies 28 4.8.3 Test design considerations and acceptance criteria 29 4.8.4 Calibration hierarchies with an available RMP 29 4.8.5 Calibration hierarchies with no available RMP 29 4.8.6 Calibrationhierarchieswith noRMPs andnoCRMs 29 4.8.7 Validation of design changes to an end-user IVD MD calibrator .30 .30 4.9 Additional calibration hierarchy documentation responsibilities. iii IS0 2020-All rights reserved