ISO INTERNATIONAL STANDARD 14160 Third edition 2020-09 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices Sterilisation desproduitsde santé-Agents sterilisants chimiques liquides pour dispositifs medicaux non réutilisables utilisant des tissus animauxetleursderivesExigencespour la caracterisation,le développement, lavalidation et le controle de routine d'un procedé de sterilisation de dispositifsmedicaux Reference number IS0 14160:2020(E) ISO @ISO 2020 IS0 14160:2020(E) COPYRIGHTPROTECTEDDOCUMENT @IS02020 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 below or Iso's memberbody in the country ofthe requester. ISO copyright office CP 40i : Ch.de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22.749 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2020 - All rights reserved IS0 14160:2020(E) Contents Page Foreword ..iv Introduction. .. 1 Scope. 2 Normative references 3 Terms and definitions 4 General. .7 5 Sterilizing agent characterization 5.1 General .7 .1 5.2 Sterilizing agent 5.3 Microbicidal effectiveness .7 5.4 Effects on materials. ..8 5.5 Safety and the environment. ..8 Process and equipment characterization .8 6 6.1 General 6.2 Process characterization ..8 6.3 Equipment characterization ..9 7 ..9 Product definition 8 Process definition. ..10 8.1 Purpose. .10 8.2 Determination oftheinactivation kinetics .10 8.3 Methodforneutralization .11 8.4 Safety quality and performance .11 Validation 9 .11 9.1 General. .11 9.2 Installation gualification ..12 9.2.1 Equipment .12 9.2.2 .12 Installation 9.3 Operational qualification .12 9.4 Performancequalification .13 ..13 9.4.1 General. 9.4.2 Microbiological performancequalification (MPQ) .13 9.4.3 Physicalperformancequalification ..14 9.4.4 Asepticprocessingqualification .15 9.5 Review and approval of validation ..15 10 Routinemonitoring and control ..16 11 Productreleasefrom sterilization. .17 12 Maintaining process effectiveness. .17 .17 12.1 General 12.2 Maintenance ofequipment ..18 12.3 Requalification ..18 12.4 Assessment of change ..18 AnnexA(informative)Guidancefortheapplicationofthisdocument. ..19 AnnexB (normative)Determinationoflethal rateofthesterilizationprocess .31 Annex C (informative) Flowchart for microbicidal effectiveness (see 5.3),process definition (seeClause8),andmicrobiological performancequalification (see9.4.2) .35 Bibliography .36 @ IS0 2020 - All rights reserved ili