ISO INTERNATIONAL STANDARD 11137-2 Third edition 2013-06-01 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose Stérilisation des produits de santé - Irradiation - Partie 2:Etablissement de la dose stérilisante Reference number IS0 11137-2:2013(E) TSO @IS02013 IS0 11137-2:2013(E) COPYRIGHTPROTECTEDDOCUMENT @IS02013 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior 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 ii @ IS0 2013 - All rights reserved IS0 11137-2:2013(E) Contents @Page Foreword V Introduction .vi 1 Scope. 1 2 Normative references 3 Terms, definitions, and abbreviated terms 1 3.1 Terms and definitions. 1 3.2 Abbreviated terms. 3 4 Definition and maintenance of product families for dose setting, dose substantiation, and sterilization dose auditing 4 4.1 General 4 4.2 Defining product families 4 4.3 Designation of product to represent a product family for performance of a verification dose experiment or sterilization dose audit. 5 4.4 Maintaining product families 6 4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family. .7 5 Selection and testing of product for establishing the sterilization dose .7 5.1 Nature of product. .7 5.2 Sample item portion (SIP), .8 5.3 Manner of sampling. .9 5.4 Microbiological testing. 9 5.5 Irradiation .9 6 Methods of dose establishment .9 7 Method 1: dose setting using bioburden information .10 7.1 Rationale. 10 7.2 Procedure for Method 1 for product with an average bioburden greater than or egual to1,oformultipleproductionbatches 11 7.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,o for a single production batch 17 7.4 Procedure for Method 1 for product with an average bioburden in the range O,1 to 0,9 for multiple or single production batches. 19 8 Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor 20 8.1 Rationale.. 20 8.2 Procedure for Method 2A 21 8.3 ProcedureforMethod2B 24 9 Method VDmax Substantiation of 25 kGy or 15 kGy as the sterilization dose .28 9.1 Rationale. .28 9.2 Procedure for Method VDmax25 for multiple production batches 29 9.3 Procedure for Method VDmax25 for a single production batch. 34 9.4 Procedure for Method VDmax15 for multiple production batches .37 9.5 Procedure for Method VDmax15 for a single production batch 40 10 Sterilization dose audit 43 10.1 Purpose and frequency. 43 10.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A, or Method 2B. 43 10.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25 or Method VDmax15. 46 10.4 Failure of a sterilization dose audit 52 11 Worked examples .52 @ IS0 2013 - All rights reserved ii