ISO INTERNATIONAL STANDARD 11737-1 Third edition 2018-01 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on products Sterilisation des produits de santé - Methodes microbiologiques Partie 1: Determination d'une population de microorganismes sur des produits Reference number IS011737-1:2018(E) os1 @IS02018 IS0 11737-1:2018(E) .7031496-LfNr.8247813001-2018-01-18 09:23 COPYRIGHTPROTECTEDDOCUMENT Verlag-KdNr. @ IS0 2018 All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 /SudAG 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 CP 40i: Ch. de Blandonnet 8 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +4122 749 09 47 [email protected] www.iso.org Published in Switzerland i @ IS0 2018 - All rights reserved IS0 11737-1:2018(E) Contents Page Foreword ..iv Introduction. ...vi 1 Scope. 2 Normative references ...1. 3 Terms and definitions 4 General requirements. ..4 4.1 Documentation .4 4.2 Management responsibility .5 4.3 Product realization. ..5 4.4 Measurement, analysis and improvement ..5 5 Selection of products .5 5.1 General ..5 5.2 Sample item portion (SIP) .6 6 Methods of determination and microbial characterization of bioburden ..6 6.1 Determination of bioburden. .6 6.1.1 Selection of an appropriate method .6 6.1.2 Neutralization of inhibitory substances 7 6.1.3 Removal of microorganisms .7 6.1.4 Culturing of microorganisms 6.1.5 Enumeration of microorganisms .1 6.2 Microbial characterization of bioburden 1 7 Validation of the method for determining bioburden .8 7.1 General .8 7.2 Validation .8 8 Routine determination of bioburden and interpretation of data .8 8.1 General .8 8.2 Limits of detection and plate counting. ..8 8.3 Microbial characterization. ..8 8.4 Bioburdendataforextentoftreatment .9 8.5 Bioburden spikes 9 8.6 Bioburden levels .9 8.7 Data analysis .9 8.8 Statistical methods .9 9 Maintenance of the method for determining bioburden. ..9 9.1 Changes to the product and/or manufacturing process .9 9.2 Changes to the method for determining bioburden .9 9.3 Requalification of the method for determining bioburden .9 Annex A (informative) Guidance on the determination of a population of microorganisms onproducts .10 Annex B (informative) Guidance on methods to determine bioburden ..27 Annex C (informative) Validation of bioburden recovery efficiency ..37 Annex D (informative) Typical assignment of responsibilities ..45 Bibliography .47 Normen-Download-Beuth-TUV @ IS0 2018 - All rights reserved iii