ISO INTERNATIONAL STANDARD 28218 First edition 2010-10-01 Radiation protection Performance criteria for radiobioassay Radioprotection - Criteres de performance pourI'analyse radiotoxicologique Reference number ISO 28218:2010(E) @ ISO 2010 ISO 28218:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The Iso Central Secretariat 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 COPYRIGHTPROTECTEDDOCUMENT ? ISO2010 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 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 + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ ISO 2010 - All rights reserved ISO 28218:2010(E) Contents Page Foreword .iv Introductior 1 Scope 2 Normative references 3 Terms anddefinitions 2 4 Symbols 6 5 Performance measures... 5.1 Decision threshold (y*) and detection limit (y#) 5.2 Relative bias and bias performance criteria ... 10 5.3 Repeatability performance criteria .. 6 Performance criteria for in vivo radiobioassay ... 12 6.1 12 6.2 Responsibilities of the customer that could impact the service laboratory's performance 12 6.3 Servicelaboratory criteria.. 6.4 Identificationofradionuclides 13 6.5 Quantification 6.6 Reporting results 6.7 Records retention.. 15 7 Performance criteria for in vitro radiobioassay ... 15 7.1 15 7.2 Responsibilities of the customer that could impact the service laboratory's performance 7.3 Analytical methodology.... 16 7.4 Reporting results.. 17 7.5 Records retention.. 17 8 Quality assurance and quality control for radiobioassay laboratories ..... 8.1 General 18 8.2 Quality assurance. 18 8.3 Quality assurance plan 19 8.4 Qualitycontrol ... .20 9 Performance testing programme ... 9.1 General 21 9.2 In vivo radiobioassay 22 9.3 In vitro radiobioassay ... 25 Annex A (informative) Detection limit Models for applications 29 Annex B (informative) Detection iimit Appiication exampies . ationghtsreserved ili