Sterilization of health care products - Moist heat - Requirements for development, validation and routine control of a sterilization process for medical devices
Specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. Moist heat sterilization processes covered by this standard include saturated steam venting processes, saturated steam active air removal processes, air steam mixture processes, water spray processes, and water immersion processes.