ISO INTERNATIONAL STANDARD 20166-3 First edition 2018-12 Molecular in vitro diagnostic examinations Specifications for pre. examination processes for formalin- fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA Analyses dediagnosticmoleculaire invitro-Specificationsrelatives aux processuspreanalytiques pour les tissus fixesauformol et inclus en paraffine (FFPE)- Partie3:ADNextrait Reference number IS0 20166-3:2018(E) ISO @ IS0 2018 IS020166-3:2018(E) COPYRIGHTPROTECTEDDOCUMENT IS02018 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 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:+4122749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2018 - All rights reserved IS0 20166-3:2018(E) Contents Page Foreword ..iv Introduction. .. 1 Scope. 2 Normative references 3 Terms and definitions 4 General considerations. ..4 5 Outside the laboratory .5 5.1 Specimen collection 5 5.1.1 General .5 5.1.2 Information about the specimen donor/patient 5 5.1.3 Informationaboutthespecimen .5 5.1.4 Specimen processing 6 5.2 Transport requirements. .6 1 6 Insidethe laboratory 6.1 Informationaboutthereceptionofthespecimen .7 6.2 .7 Formalin fixation of the specimen or sample(s) 6.3 Evaluation of thepathology ofthe specimenand selection ofthe sample(s) .8 6.4 .9 Post-fixationoffrozensamples 6.5 Decalcification .9 6.6 Processingandparaffinembedding .9 6.7 Storage requirements. .10 6.8 Isolation of DNA .10 6.8.1 General. .10 6.8.2 GeneralinformationforDNAisolationprocedures .10 6.8.3 Using commercial kits .11 6.8.4 Usingthelaboratories'ownprotocols .11 6.9 QuantityandqualityassessmentofisolatedDNA ..12 6.10 Storage of isolated DNA .12 AnnexA (informative)Impact ofthe storage temperature onDNA Integrity in FFPEblocks oftissue .14 Bibliography .16 @ IS0 2018 - All rights reserved ili