ISO/TC 198/WG 3 - Moist heat sterilization

This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.

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.

Specifies requirements for the use of moist heat in sterilization process development, validation of the sterilization process and control of routine sterilization. Covers all moist heat processes, including saturated steam and air-steam mixtures, and applies to all industrial manufacturers and all others who perform contract moist heat sterilization. Although moist heat sterilization in non-industrial health care facilities is not specifically covered, the principles outlined may be useful to the user of moist heat sterilization in these facilities.