GB 8599-2023

This document defines the terms and definitions of large-scale pressure steam sterilizers (hereinafter referred to as "sterilizers"), stipulates their classification and requirements, and describes the test methods.
This document applies to sterilizers with side openings in the sterilization chamber, capable of loading at least one sterilization unit or with a volume of not less than 60L, and equipped with a vacuum function. This sterilizer is mainly used for the sterilization of healthcare products and their accessories (excluding liquid items, flammable and explosive items, biological waste, and human tissues).
Note: Sterilizers designed and manufactured in accordance with this document also need to consider the impact of environmental factors during the product life cycle. Environmental impact factors are described in Appendix A.