GB 18278-2000 is aimed at industrial heating and humidity sterilization of health care products, and clearly confirms and routinely controls the requirements. It stipulates the design, installation and operation standards of sterilizing equipment to ensure accurate control of key parameters such as temperature, pressure and time. The verification process of sterilizing process is described in detail, and the best sterilizing conditions need to be determined after multiple tests. At the same time, daily monitoring is standardized, and equipment performance is required to be checked regularly and sterilized data is recorded. The standard aims to ensure that health care products are sterile and mass stable after industrial heating and humidity sterilization, and provides a solid guarantee for the safe use of patients. It is an important basis for the control of sterilizing mass control of medical products.
| Status | Abolish | ||
|---|---|---|---|
| CCS | C47 | ICS | 11.080 |
| Release Date | 2000-12-18 00:00:00 | Implementation Date | 2001-05-01 00:00:00 |