ISO/FDIS FINAL INTERNATIONAL DRAFT STANDARD 13022 ISO/TC194/SC 1 Medical products containing viable Secretariat: DIN human cells Application of risk Voting begins on: 2012-01-12 management and requirements for processing practices Voting terminates on: 2012-03-12 Produits médicaux contenant des cellules viables d'origine humaine Application du management du risque et exigences relatives aux pratiques de preparation 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 THEY AREAWAREAND TO PROVIDE SUPPOR- TING DOCUMENTATION Reference number BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO- LOGICAL, COMMERCIAL AND USER PURPOSES ISO/FDIS 13022:2012(E) DRAFT INTERNATIONAL STANDARDS MAY ON ISO OCCASION HAVE TO BE CONSIDERED IN THE DARDS TO WHICH REFERENCE MAY BE MADE IN ISO2012 IHS unde license from IHS Not for Resale ISO/FDIS 13022:2012(E) Copyright notice This ISO document is a Draft International Standard and is copyright-protected by IsO. Except as permitted 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 2012 - All rights reserved ed without license from IHS Not for Resale ISO/FDIS 13022:2012(E) In accordance with the provisions of Council Resolution 15/1993, this document is circulated in the English language only ili HS unde Not for Resale