FINAL INTERNATIONAL ISO/FDIS DRAFT STANDARD 23640 ISO/TC212 In vitro diagnostic medical devices - Secretariat:ANSI Evaluation of stability of in vitro Voting begins on: 2011-09-08 diagnostic reagents Voting terminates on: Dispositifs medicaux de diagnostic in vitro - Evaluation de la stabilité 2011-11-08 des reactifs de diagnostic in vitro Please see the administrative notes on page ili RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEYAREAWAREANDTOPROVIDESUPPOR TING DOCUMENTATION Reference number BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO- LOGICAL, COMMERCIAL AND USER PURPOSES ISO/FDIS 23640:2011(E) DRAFT INTERNATIONAL STANDARDS MAY ON OSI OCCASIONHAVETO BECONSIDEREDINTHE LIGHT OF THEIR POTENTIAL TO BECOME STAN- DARDS TO WHICH REFERENCE MAY BE MADE IN @ISO2011 IHS unde Not for Resale ISO/FDIS23640:2011(E) Copyright notice This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted under the applicable laws of the user's country, neither this Iso draft nor any extract from it may be reproduced, or otherwise, without prior written permission being secured. Requests for permission to reproduce should be addressed to 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 + 412274909 47 E-mail [email protected] Web www.iso.org Reproduction may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. @ ISO 2011 - All rights reserved rmitted without license from IHS Not for Resale ISO/FDIS23640:2011(E) ISO/CENPARALLEL PROCESSING This final draft has been developed within the International Organization for Standardization (isO), and processed under the Iso-lead mode of collaboration as defined in the Vienna Agreement. The final draft was established on the basis of comments received during a parallel enquiry on the draft. two-month approval vote in ISO and formal vote in CEN. Positive votes shall not be accompanied by comments. Negative votes shall be accompanied by the relevant technical reasons. ii Not for Resale