ISO INTERNATIONAL STANDARD 11138-4 Secondedition 2017-03 Sterilization of health care products Biological indicators - Part 4: Biological indicators for dry heat sterilization processes Sterilisation des produits de santé - Indicateurs biologiques - Partie 4: Indicateurs biologiques pour la sterilisation a la chaleur seche Reference number IS0 11138-4:2017(E) [so International Organization for Standardization @ IS0 2017 IS0 11138-4:2017(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 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 copyrightoffice 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 Internatinair PrganizationforStandardization icensee-ZHEJIANG INSTOF STANDARDIZAoISQ07 -All rights reserved etworking permitted without license from IHS IS0 11138-4:2017(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions 4 General requirements. .1 5 Test organism ..1 6 Suspension. ..2 7 Carrierand primary packaging ..2 8 Inoculated carriers and biological indicators ..2 9 Population and resistance ..2 Annex A (normative) Method for determination of resistance to dry heat sterilization. Annex B (normative) Calculation of z value .5 Bibliography .8 iii e=ZHEJIANG INSTOFSTANDARDIZATION C15956617 vided by IHS underI ithout license from IHS