YY/T 0646-2022 Active

This document specifies the types of sterilization cycles, requirements, test methods, and inspection rules for small pressure steam sterilizers (hereinafter referred to as sterilizers).
This document applies to automatically controlled small pressure steam sterilizers that generate steam by electric heating or connect to external steam sources, have side-opening sterilization chambers, a volume of less than 60 L, cannot accommodate a single sterilization unit (300 mm × 300 mm × 600 mm), and have a rated working pressure of no more than 0.25 MPa with a preset sterilization temperature ranging from 115 ℃ to 138 ℃.
Note: In this document, unless otherwise specified as absolute pressure, all pressures refer to gauge pressure.
This document does not apply to vertical pressure steam sterilizers, portable pressure steam sterilizers, cassette steam sterilizers, or liquid sterilization.
This document does not specify safety requirements related to the risk of use, nor does it stipulate requirements for the validation and routine control of moist heat sterilization.