GB 8599-2023Technical requirements for large steam sterilizers (English PDF)

1 Scope

This document defines the terms and definitions of large pressure steam sterilizers (hereinafter referred to as "sterilizers"), stipulates classifications, requirements, and describes experiment method.

This document is applicable to sterilization chambers with side openings that can load at least one sterilization unit or a volume of not less than 60L and a vacuum function.

Bacteria. This sterilizer is mainly used for sterilizing medical and health care products and their accessories (excluding liquid items, flammable and explosive items, biological waste, human sterilization of body tissue).

Note. Sterilizers designed and produced according to this document also need to consider the impact of environmental factors in the product life cycle. See Appendix A for environmental impact factors.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations

For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.

GB/T 3768 Acoustic sound pressure method determines the sound power level and sound energy level of noise sources using a simplified method of enveloping the measuring surface above the reflecting surface.

Yifa

GB/T 3785 (all parts) Electroacoustic sound level meter

GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements

GB 4793.4 Safety requirements for electrical equipment for measurement, control and laboratory use Part 4.Sterilizers for processing medical materials and special requirements for washer-disinfectors

GB/T 16839.1 Thermocouples Part 1.Electromotive force specifications and tolerances

GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements

GB 18278.1-2015 Moist heat sterilization of health care products Part 1.Development, validation and routine of sterilization process of medical devices

Control requirements

GB 18281.3 Biological indicators for sterilization of medical and health care products Part 3.Biological indicators for moist heat sterilization

GB 18282.1 Chemical indicators for sterilization of health care products Part 1.General principles

GB 18282.3 Chemical Indicators for Sterilization of Healthcare Products Part 3.Class II Indicators for BD Class Vapor Penetration Testing physical system

GB/T 19633 (all parts) Packaging of terminally sterilized medical devices

GB/T 19971-2015 Terminology for sterilization of medical and healthcare products

GB/T 30121 Industrial platinum thermal resistor and platinum temperature sensing element

3 Terms and definitions

The following terms and definitions as defined in GB 18278.1-2015 and GB/T 19971-2015 apply to this document.