ISO INTERNATIONAL STANDARD 11138-7 First edition 2019-03 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results Sterilisation des produits de santé - Indicateurs biologiques - Partie 7: Directives générales pour la sélection, I'utilisation et I'interpreétation des résultats Reference number ISO 11138-7:2019(E) osi @ IS0 2019 IS0 11138-7:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2019 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 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 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved IS0 11138-7:2019(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope. 2 Normative references 3 Terms and definitions 4 General. ..4 5 Characteristics of biological indicators ..6 5.1 General .6 5.2 Test organism suspension for direct inoculation of products ..7 5.3 Inoculated carriers .7 5.4 Self-contained biological indicators .8 6 Selection of supplier ..8 6.1 General ..8 6.2 Documentation 6.2.1 General .9 6.2.2 Manufacturer audit. .10 7 Biological indicators in process development .11 7.1 General. .11 7.2 Overkill approach ..11 7.3 Combined biological indicator and bioburden method ..12 7.4 Bioburden method ..13 8 Biological indicators in sterilization validation ..13 8.1 General ..13 8.2 Placement and handling of biological indicators ..14 8.3 Sterilizer qualification. ..14 8.4 Performance qualification .14 8.5 Review and approval of validation .. 15 8.6 Requalification.. .. 15 9 Biological indicators in routine monitoring ..15 9.1 General. .15 9.2 Placement and handling of biological indicators ..16 9.3 Process challenge device.. ..16 10 Interpretation and acceptance criteria ..17 10.1 General. ..17 10.2 Interpretationofresults ..17 11 Application of biological indicator standards ..17 11.1 General assessment of biological indicator performance by the user .17 11.2 Nominal population of test organism. .18 11.3 Resistance determination. ..19 11.3.1 General .19 11.3.2 Survivor curve method 19 11.3.3 Fraction-negative method 19 11.3.4 Survival-kill response characteristics 20 11.4 z value determination 20 11.4.1 General 20 11.4.2 Graphically plotting the z value. 20 11.4.3 Mathematicallycalculatingthezvalue 21 11.4.4 Correlationcoefficient,r,forthezvalue 22 11.5 F(T, z) equivalent sterilization value determination 22 11.6 Establishing spore-log-reduction .22 @ IS0 2019 - All rights reserved ii