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
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
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
国家药品监督管理局
Pages:
36 pages
Scope
本文件界定了大型压力蒸汽灭菌器(以下简称“灭菌器”)的术语和定义,规定了分类、要求,描述了试验方法。
本文件适用于灭菌室侧向开口且能装载至少一个灭菌单元或容积不低于60L,具有真空功能的灭菌器。该灭菌器主要用于医疗保健产品及其附件的灭菌(不包括液体物品、易燃易爆物品、生物废料、人体组织的灭菌)。
注:按本文件设计和生产的灭菌器还需考虑产品生命周期中环境因素的影响。环境影响因素见附录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