ISO INTERNATIONAL STANDARD 22442-3 First edition 2007-12-15 Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TsE) agents Dispositifs médicaux utilisant des tissus animaux et leurs dérives- Partie3:ValidationdeI'éliminationet/oudeI'inactivationdesviruset autresagentsresponsablesd'encephalopathiespongiforme transmissible (EST) Reference number ISO 22442-3:2007(E) @ ISO 2007 HS unde Not for Resale ISO 22442-3:2007(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 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 parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below COPYRIGHTPROTECTEDDOCUMENT @ISO2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, 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 2007 - All rights reserved edwithoutlicense from IHS Not for Resale ISO 22442-3:2007(E) Contents Page Foreword. Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 4.1 Risk management . 4.2 Sourcing and manufacturing process. 4.3 General requirements related to validation 5 Literature review .... 5.1 Conductoftheliteraturereview 5.2 Application of literature review output. 5.3 Viruses... 5.4 TSEagents 6 Elimination and/or inactivation study of viruses and TSE agents 6.1 General. 6.2 Protocol 6.3 Conduct of the study 6.4 Interpretation of data 7 Final report 8 Review of final report ... 9 Routine monitoring and control of critical process parameters Annex A (normative) Requirements related to literature review... Annex B (informative) Guidance on the elimination and/or inactivation study for viruses .. Annex C (informative) Guidance on the elimination and/or inactivation study for TsE agents .... Annex D (informative) Guidance on scaling down , Annex E (informative) Statistical evaluation of virus titres and reduction factors and assessment of their validity ... 18 Annex F (informative) Calculation of reduction factors . .19 .20 Bibliography. 21 Copyright International Organization for Standardizalon ghts reserved ii nse from IHS Not for Resale ISO 22442-3:2007(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies technicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeer 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. International Standards are drafted in accordance with the rules given in the ISO/lEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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