ISO INTERNATIONAL STANDARD 13495 First edition 2013-11-01 Foodstuffs Principles of selection and criteria of validation for varietal identification methods using specific nucleic acid Produits alimentaires - Principes de sélection et criteres de validation des methodes d'identification variétale utilisant des acides nucleiquesspécifiques Reference number IS0 13495:2013(E) ISO @IS02013 No reproo Not for Resale IS0 13495:2013(E) COPYRIGHT PROTECTED DOCUMENT @S02013 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the'requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax +4122 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ IS0 2013 - All rights reserved Not for Resale IS0 13495:2013(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions. ..1 3.1 Terms related to variety. .1 3.2 Terms related to DNA/RNA extraction and purification 3.3 Terms related to PCR amplification of nucleic acids 2 3.4 Terms related to detection. .3 3.5 Terms related to controls. 3 3.6 Terms related to markers 4 4 Quality assurance on the test results .4 5 Selection of methods .6 6 Markers selection 6.1 General criteria. .6 6.2 Marker set selection 6.3 SSR markers .6 6.4 Single nucleotide polymorphism (SNP) .7 7 Laboratory samples 7.1 Sample. 7 7.2 Sample size ..7 7.3 Reference material. 1 8 Laboratory validation 8.1 General .8 8.2 Intralaboratory validation criteria ..8 8.3 Interlaboratory validation criteria .9 9 Interpretation and expression of the results .10 9.1 General. .10 9.2 Data annotation system .10 9.3 Analysis of results.. ..11 9.4 Expression of results ..11 10 Test report .11 Bibliography .13 CopyrntntematonalOanadiza rights reserved iii ded by IHS under lic cense with ISt ed without license from IHS Not for Resale