DS DS/EN ISO 17665-1
DS DSEN SO 17665-1 2006-AUG-28 Sterlzaton of health care products - Most heat - Part 1 Requrements for the development valdaton and routne control of a sterlzaton process for medcal devces
DS DSEN SO 17665-1 2006-AUG-28 Sterlzaton of health care products - Most heat - Part 1 Requrements for the development valdaton and routne control of a sterlzaton process for medcal devces
ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:
- saturated steam venting systems;
- saturated steam active air removal systems;
- air steam mixtures;
- water spray;
- water immersion.