IS0 11138-2:2017(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form writtenpermission.PermissioncanberequestedfromeitherIsOattheaddressbeloworIsO'smemberbodyinthecountryof the requester. ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org ii @ IS0 2017 - All rights reserved IS0 11138-2:2017(E) Contents Page Foreword iv Introduction 1 Scope. 2 Normative references. 3 Terms and definitions 4 General requirements. 5 Test organism 6 Suspension .2 7 Carrier and primary packaging 8 Inoculated carriers and biological indicators. 2 9 Population and resistance. 2 Annex A (normative) Method for determination of resistance to ethylene oxide sterilization Annex B (informative) Rationale for the inclusion of a second minimum D value specification as a result of changes to the test gas used to evaluate resistance and deletion of the requirement for a minimum D value at 3o °C. Bibliography @ IS0 2017 - All rights reserved iii IS0 11138-2:2017(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through Iso technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with IsO, also take part in the work. ISo collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the IsO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of Iso documents should be noted. This document was drafted in accordance with the editorial rules of the ISo/IEc Directives, Part 2 (see WWw.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISo shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the Iso list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement, For an explanation on the voluntary nature of standards, the meaning of Iso specific terms and expressionsrelatedtoconformityassessmentaswellasinformationaboutIso'sadherencetothe World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html This document was prepared by Technical Committee ISo/TC 198, Sterilization of health care products. This third edition cancels and replaces the second edition (Is0 11138-2:2006), which has been technically revised. A list of all parts of IS0 11138 can be found on the ISO website. iv @ IS0 2017 - All rights reserved