Medical devices sterilized by moist heat using saturated steam, steam or air-steam mixed gas, water spray, water immersion, etc. (HS code(s): 300590; 392329; 701790; 842129; 901831; 901839; 902131); (ICS code(s): 11.080.10)

National Standard of the P.R.C., Sterilization of health care products—Moist heat—Requirements for the development,validation and routine control of a sterilization process for medical devices; (118 page(s), in Chinese)

This document specifies requirements for the development, qualification, and routine control of moist heat sterilization processes for medical devices, applicable to industrial sterilization applications.

This document contains guidance intended to explain requirements set forth in the normative sections, so as to promote good practices related to moist heat sterilization processes specified herein.

This document does not apply to the development, qualification, and routine control of processes for the inactivation of agents causing transmissible spongiform encephalopathies (e.g., scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease). This document does not specify occupational safety requirements related to the design and operation of moist heat sterilization facilities.