ISO/TR TECHNICAL REPORT 22442-4 First edition 2010-12-01 Medical devices utilizing animal tissues and their derivatives Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes Dispositifsmédicauxutilisantdestissusanimauxetleursdérivés Partie 4: Principes d'inactivation et/ou d'élimination des agents transmissibles de I'encéphalopathie spongiforme bovine (EsB) et essais de validation de ces procédés Reference number ISO/TR 22442-4:2010(E) @ISO 2010 HS unde I without license from IHS Not for Resale ISO/TR 22442-4:2010(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 COPYRIGHTPROTECTEDDOCUMENT @ISO2010 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either isO at the address below or IsO's memberbody 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 2010-All rights reserved ed without license from IHS Not for Resale ISO/TR 22442-4:2010(E) Contents Page Foreword .iv Introduction 1 Scope 2 Normative references.. 3 Terms and definitions . 4 Elimination of TSE agents: basic considerations 4.1 General .... 4.1.1 TSEs of concern. 4.1.2 Animal tissues of concern.... 4.1.3 Tissues infected with TSE agents 5 Potential methods to eliminate TSE agents .. 5.1 Methods for inactivating infectivity .... 5.1.1 5.1.2 Physical methods for inactivating TSE infectivity .. 5.1.3 Chemical methods for inactivating TSE infectivity. 5.2 Methods for removing TSE infectivity without inactivating infectivity. 6 Experimental validation of methods for eliminating TSE agents from medical devices utilizing non-viable animal tissues 6.1 General 6.2 Defining of product families for purposes of designing TsE process validation studies... 6.3 Selection and testing of product for establishing and verifying the infecting dose of TSE agent .......... 6.4 TSE agent spiking materials . .6 6.5 Availability of bioassay animals (conventional and transgenic mice, other rodents, farm 6.6 Potential development of cell culture assays for infectivity.. 6.7 Correlations between PrpTSE E and infectivity assays... 6.8 Reductions in infectivity compared with failure to detect at limits of detection........ 6.9 in infectivity rather than variations in assay performance ... .8 6.10 Requirements for step-wise reductions in PrpTSE E and infectivity verses whole-process validation.. .8 Bibliography.. CopyrghtInternational OrganizaionStadardizaoghtsreserved ii ed without license from IHS Not for Resale