This standard specifies the requirements and test methods for biological indicators used in the heat and humidity sterilizing process. It is applicable to the heat and humidity sterilizing process using dry saturated steam, but not to the heat and humidity sterilizing process using air mixture steam. The standard describes in detail the test microorganisms, suspensions, bacterial staining carriers, etc. of biological indicators to ensure the effectiveness and safety of the sterilizing process. This standard provides a scientific basis for the development, confirmation and routine control of the medical apparatus sterilizing process, and helps medical apparatus manufacturers to improve the level of sterilizing quality control.
| Status | Active |
|---|---|
| CCS | C47 | ICS | 11.080.01 |
| Release Date | 2015-12-10 00:00:00 | Implementation Date | 2017-01-01 00:00:00 |