International ISO Standard ISO17665 Sterilization of health care First edition products Moist heat - 2024-03 Requirements for the development, validation and routine control of a sterilization process for medical devices Sterilisation des produits de sante - Chaleur humide Exigences pour le développement, la validation et le controle de routine d'un procedé de stérilisation des dispositifs médicaux Reference number ISO 17665:2024(en) @ ISO 2024 IS0 17665:2024(en) COPYRIGHT PROTECTED DOCUMENT @IS02024 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 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 @IS02024-Allrightsreserved i IS0 17665:2024(en) Contents Page @ Foreword. Introduction. .vi 1 Scope. .1 1.1 Inclusions .1 1.2 Exclusions 1 2 Normative references 2 3 Terms and definitions 2 4 General 12 5 Sterilizing agent characterization 13 5.1 Sterilizing agent. 13. 5.2 Microbicidal effectiveness. 14 : 5.3 Effects on materials. .14: 5.4 Environmental consideration 14 6 Process and equipment characterization 14 6.1 General 14 6.2 Process characterization 14 6.3 Saturated steam sterilization processes. 15 6.4 Contained product sterilization processes 16 6.5 Equipment. .17 7 Product definition 18 8 Process definition .20 9 Validation .22 9.1 General 22 9.2 Installation qualification (IQ) 23 9.3 Operational qualification (OQ) 23 9.4 Performance qualification (PQ) .24 9.5 Review and approval of validation 26 10 Routine monitoring and control. 26 10.1 Routine monitoring. 26 10.2 Operational status... 26 10.3 Process verification.. .27 10.4 Evaluation of additional data for saturated steam sterilization processes .27 10.5 Evaluation of additional data for contained product sterilization processes. .27 10.6 Record retention 28 11 Product release from sterilization .28 12 Maintaining process effectiveness 28 12.1 Purpose 28 12.2 Demonstration of continued effectiveness 28 12.3 Recalibration 29 12.4 Equipment maintenance. 29 12.5 Regualification 29 12.6 Assessment of change 30 Annex A (informative) Guidance on the principles of moist heat sterilization and rationales for requirements. 31 Annex B (informative) Establishment and evaluation of a sterilization process primarily based on microbiological inactivation 59 Annex C (informative) Establishment and evaluation of a sterilization process primarily based onthemeasurementofphysicalparameters 73 @ IS0 2024 - All rights reserved iii IS0 17665:2024(en) Annex D (informative) Examples of moist heat sterilization cycles 83 Annex E (informative) Temperature and pressure of saturated steam for use in moist heat sterilization. .89 Annex F (informative) Guidance on the application of the normative requirements in health care facilities 93 Annex G (informative) Guidance on the designation of a medical device to a product family and processing category for sterilization by moist heat. .118 Annex H (informative) Guidance on the application of the normative requirements in industrial settings. 126 Bibliography. .150 @ IS0 2024 - All rights reserved iv IS0 17665:2024(en) 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 been established has the right to be represented on that committee. International organizations, governmental an