FINAL INTERNATIONAL ISO/FDIS DRAFT STANDARD 11135 IS0/TC198 Sterilization of health-care products Secretariat: ANSI Ethylene oxide - Requirements for the Voting begins on: 2014-03-27 development, validation and routine Voting terminates on: control of a sterilization process for 2014-05-27 medical devices Sterilisation des produits de santé - Oxyde d'ethylene - Exigences de développement, de validation et de controle de routine d'un processus de stérilisation pour des dispositifs médicaux Please see the administrative notes on page ii SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION Reference number BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO- LOGICAL, COMMERCIAL AND USER PURPOSES, IS0/FDIS 11135:2014(E) DRAFT INTERNATIONAL STANDARDS MAY ON ISO OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OFTHEIR POTENTIALTO BECOME STAN DARDS TO WHICH REFERENCE MAY BE MADE IN Copyright International Organization for Standardization NS @IS02014 IHS unde cense from IHS Not for Resale IS0/FDIS 11135:2014(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2014 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 + 41 22 749 09 47 E-mail copyright@iso.org Web www.iso.org Published in Switzerland @ IS0 2014 - All rights reserved Not for Resale IS0/FDIS 11135:2014(E) ISO/CEN PARALLEL PROCESSING This final draft has been developed within the International Organization for Standardization (Iso), and pro- cessed 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. This final draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel 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. iii No reproduction or Not for Resale