YY 0646-2008

This standard specifies the classification and basic parameters, requirements, test methods, and inspection rules for automatic control type small steam sterilizers. This standard applies to electrically heated or externally connected steam-generating automatic control type small steam sterilizers with a sterilization chamber volume not exceeding 60 L, which cannot accommodate a single sterilization unit (300 mm × 300 mm × 600 mm). This type of sterilizer is mainly used for sterilizing medical supplies or materials and instruments that may come into contact with blood or body fluids. This standard does not apply to the sterilization of sealed liquids. This standard does not stipulate safety requirements related to the scope of use risks, nor does it stipulate requirements for the validation and routine control of moist heat sterilization.