GB 15979-2002
Replaced
GB 8599-2023
Pending
National standards
force_standard
GB 8599-2023 Technical requirements for large steam sterilizers
GB 8599-2023 Technical requirements for large steam sterilizers
Price:
$ 80
Basic Information
Standard Code:
GB 8599-2023
Standard Type:
National standards
Standard Status:
Pending
is_force_gb:
yes
CCS Name:
Public medical equipment
ICS Name:
Disinfection equipment
Publish Date:
2023-09-08
Implement Date:
2026-10-01
Pages:
40 pages
Scope
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.
Development Information
Replace the following standards
Referenced Standards
GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
GB/T 19971-2015 Sterilization of health care products—Vocabulary
GB/T 3768-1996 Acoustics—Determination of sound power levels of noise sources using sound pressure—Survey method using an enveloping measurement surface over a reflecting plane
GB/T 3768-2017 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Survey method using an enveloping measurement surface over a reflecting plane
GB/T 3785-1983 Electric, sonic properties and measuring methods for sound level meters
GB/T 3785.1-2010 Electroacoustics—Sound level meters—Part 1:Specifications
GB/T 3785.1-2023 Electroacoustics—Sound level meters—Part 1:Specifications
GB/T 3785.2-2010 Electroacoustics—Sound level meters—Part 2:Pattern evaluation tests
GB/T 3785.2-2023 Electroacoustics—Sound level meters—Part 2:Pattern evaluation tests
GB/T 3785.3-2018 Electroacoustics—Sound level meters—Part 3:Periodic tests
GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements
GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements
GB 4793.4-2001 Safety requirements for electrical equipment for measurement, control and laboratory use—Particular requirements for autoclaves using steam for the treatment of medical materials and for laboratory process
GB 4793.4-2019 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 4:Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
GB/T 16839.1-1997 Thermocouples—Part 1:Reference tables
GB/T 16839.1-2018 Thermocouples—Part 1:EMF specifications and tolerances
GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18281.3-2015 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization processes
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
GB 18282.1-2015 Sterilization of health care products—Chemical indicator—Part 1:General requirements
GB 18282.3-2009 Sterilization of health care products—Chemical indicators—Part 3:Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
GB/T 19633-2005 Packaging for terminally sterilized medical devices
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
GB/T 30121-2013 Industrial platinum resistance thermometers and platinum temperature sensors
GB/T 18281.3-2024 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization processes
GB/T 18282.1-2025 Sterilization of health care products—Chemical indicators—Part 1:General requirements
GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
Related Standards
YY 0504-2005
Replaced
YY 0504-2005 Portable mode steam sterilizers
YY 1007-2005
Replaced
YY 1007-2005 Vertical mode steam sterilizers
GB 4793.8-2008
Replaced
GB 4793.8-2008 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 2-042:Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes
YY 0646-2008
Replaced
YY 0646-2008 Small steam sterilizers—Automatic type
YY 0215-2008
Replaced