YY 0503-2023 "ethylene oxide Autoclave" standard specifies the classification, requirements and corresponding test methods of automatic control Autoclave for sterilizing using ethylene oxide gas. The standard applies to the industrial production of medical apparatus and the sterilizing process in medical institutions. The document clearly states that Autoclave does not include sterilizing methods and equipment for directly injecting ethylene oxide or mixtures containing ethylene oxide into Encasement or flexible cavity. The standard does not cover the requirements of Autoclave as a Pressure Vessel, nor does it specify the treatment requirements for waste gas, wastewater and other wastes from ethylene oxide sterilization, as well as the provisions for ethylene oxide residues. The implementation of this standard helps to ensure the safety and effectiveness of Autoclave during use, and to ensure that the sterilized mass of medical apparatus meets the requirements of relevant regulations and standards.
| Status | Active |
|---|---|
| CCS | ICS |
| Release Date | 2023-06-20 00:00:00 | Implementation Date | 2025-07-01 00:00:00 |