ISO/TR TECHNICAL REPORT 79 First edition 2015-04-15 Reference materials - Examples of reference materials for qualitative properties Materiaux de réference - Exemples de materiaux de reference pour les propriétésqualitatives Reference number ISO/TR79:2015(E) SO International Organization for Standardization Zhejiang Institute of Standardization 5956617 IS02015 vided by IHS under itted without license from IHS IS0/TR 79:2015(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2015 All rights reserved. Unless otherwise specified, 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 on the internet or an intranet, without prior 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 Prganizationfor Standardization I by IHS unde Not for Resale, 2015/6/29 09:20:57 etworking permitted without license from IHS IS0/TR 79:2015(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope. 2 Reference materials certified for their DNA sequence 2.1 General 2.2 Selected examples of certified reference materials 2.3 Certification approaches applied. .2 2.3.1 Processing of the materials .2 2.3.2 Purity assessment. .3 2.3.3 Genomic DNA CRMs .4 2.3.4 Characterization (leading to certified values) ..4 2.3.5 Additional characterization (leading to non-certified values) .4 2.3.6 Suitability study ..4 2.3.7 Homogeneity study. .5 2.3.8 Minimum sample intake 2.3.9 Short-term and long-term stability .5 2.3.10 Identification probability 2.3.11 Documentary and metrological traceability ..6 3 Organic reference materials for qualitative analysis .6 3.1 General ..6 3.2 Verification of the identification of a marker for steroid abuse .7 3.3 The added value of knowing the synthetic procedure.. .9 4 Biospecimens of human origin, certified for qualitative properties. ..10 4.1 General .10 4.2 Selected human biospecimen examples of reference materials .10 4.3 Certification approaches applied .11 4.3.1 General. .11 4.3.2 Processing of the materials ..11 4.3.3 Purity assessment ..11 4.3.4 Characterization ..12 4.3.5 Suitability study .15 4.3.6 Homogeneity study .16 4.3.7 Stability study .16 4.4 Conclusion on biospecimens as reference material certified for qualitative properties.... 16 4.4.1 General. .16 4.4.2 Documentary and metrological traceability 17 5 Reference material for darnel seed identity .17 5.1 General .17 5.2 Preparation of the reference materials. .17 5.3 Intendeduse ..18 5.4 Characterization. ..18 5.4.1 Qualitative property to be characterized ..18 5.4.2 Principal of characterization. ..18 5.4.3 Characterization of the reference material fordarnel seed identity .24 5.5 Homogeneity and stability study .28 5.6 Uncertainty .28 5.7 Expressing the qualitative property of the reference material .28 5.8 Traceability .28 6 Colour of freshwater cultured pearls .29 6.1 General 29 6.2 Homogeneity testing .29 7 European Pharmacopoeia reference standards for qualitative analysis .32 ntemaional ganzation@sS25-All rights reserved iii LicenseeZhejang Institute of Standardization 5956617 bvided by IHS under license with ISO NotforResale,2015/6/2909:20:57 ed without license from IHS