ISO INTERNATIONAL STANDARD 11140-4 Second edition 2007-03-15 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration Sterilisation des produits de santé Indicateurs chimiques - Partie 4: Indicateurs de Classe 2 comme alternative a I'essai de Bowie et Dick pour la détection de la pénétration de la vapeur Reference number ISO 11140-4:2007(E) @ ISO 2007 y IHS under I without license from IHS Not for Resale ISO 11140-4:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF fle can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. @SO2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, 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 [email protected] Web www.iso.org Published in Switzerland @ ISO 2007 - All rights reserved ermittedwithoutlicense from IHS Not for Resale ISO 11140-4:2007(E) Contents Page Foreword. Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements... 5 Indicator system format.. 6 Performance requirements. 7 Packaging and labelling.... 8 Quality assurance ... Annex A (normative) Determination of indicator strength during and after steam sterilization ... Annex B (normative) Standard test cycles.... Annex C (normative) Estimation of visual difference between colour of the substrate and of the changed or unchanged indicator system by determination of relative reflectance density .... 15 Annex D (normative) Determination of uniform colour change on exposure to saturated steam ....... 19 Annex E (normative) Determination of equivalence of the alternative indicator to the Bowie and Dick test...... ..20 Annex F (normative) Determination of reproducibility of fail conditions created in a standard test 22 Annex G (normative) Determination of indicator colour change on exposure to dry heat.. Annex H (normative) Determination of shelf life of product. .27 Annex I (normative) Accelerated ageing of test samples Annex J (normative) Steam exposure apparatus and steam for test purposes.. Annex K (normative) Standard test pack.... .32 Annex L (normative) Air injection system . 33 Bibliography.... Copyrigh Intemational Organization for standardizalinghts reserved ii se from IHS Not for Resale ISO 11140-4:2007(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (isO: member bodies). The work of preparing International Standards is normally carried out through IsO technical committees. Each member body interested in a subject for which a technical committee has beer non-governmental,inliaisonwithIsO,also take part in the work.Iso collaborates closely withthe InternationalElectrotechnicalCommission(iEC)onallmattersofelectrotechnicalstandardization. International Standards are drafted in accordance with the rules given in the ISO/lEc Directives, Part 2 The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Stan