ISO INTERNATIONAL STANDARD 11138-5 Secondedition 2017-03 Sterilization of health care products Biological indicators - Part 5: Biological indicators for low- temperature steam and formaldehyde sterilization processes Sterilisation des produits de santé - Indicateurs biologiques - Partie 5: Indicateurs biologiques pour la sterilisation a la vapeur d'eau et au formaldéhyde a basse température Reference number IS0 11138-5:2017(E) International Organization for Standardization @ IS0 2017 ed without license from IHS IS0 11138-5:2017(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 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. ISOcopyrightoffice 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 Internationai ibrg DrganizationforStandardization Licensee-ZHEJIANG INST OF STANDARDIZAISQ 07 - All rights reserved Not for Resale, 2017/5/11 01:57:00 networking permited withoutlicense from IHS IS0 11138-5:2017(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions 4 General requirements. ..1 5 Test organism. ..2 6 Suspension. ..2 7 Carrier and primary packaging .2 8 Inoculated carriers and biological indicators ..2 9 Population and resistance ..2 Annex A (normative) Method for determination of resistance to low-temperature steam and formaldehyde. ..4 Annex B (informative) Rationale for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators. .6 Bibliography 7 iii ee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 ithout license from IHS Not for Resale, 2017/5/11 01:57:00