Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
This National Standard of Canada is based on International Standard ISO 17665-1:2006. Scope 1.1 Inclusions 1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.
1.1.2 Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to:
a) saturated steam venting systems;
b) saturated steam active air removal systems;
c) air steam mixtures;
d) water spray;
e) water immersion.