This standard specifies the requirements for the development, confirmation and routine control of the heat and humidity sterilizing process of medical apparatus, which is applicable to various heat and humidity sterilizing methods such as saturated steam. The standard also covers the mass management system requirements for the sterilizing process, but does not apply to the sterilizing process where multiple sterilizing agents are used in combination. This standard provides comprehensive technical guidance for medical apparatus manufacturers in heat and humidity sterilizing to ensure the safety and effectiveness of the sterilizing process.
| Status | Active |
|---|---|
| CCS | C47 | ICS | 11.080.01 |
| Release Date | 2015-12-10 00:00:00 | Implementation Date | 2017-01-01 00:00:00 |