|
Standard
ISO 17665
First edition
Sterilization of health care
2024-03
products — Moist heat —
Requirements for the development,
validation and routine control of
a sterilization process for medical
devices
Stérilisation des produits de santé — Chaleur humide —
Exigences pour le développement, la validation et le contrôle de
routine d’un procédé de stérilisation des dispositifs médicaux
Reference number
ISO 17665:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
ISO 17665:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
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
Email: [email protected]
Website: www.iso.org
Published in Switzerland
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO 17665:2024(en)
Contents Page
Foreword .v
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 .
...