GB 15979-2002
Replaced
YY 0503-2023
Active
Industry standards-Medicine
YY 0503-2023 Ethylene oxide sterilizer
YY 0503-2023 Ethylene oxide sterilizer
Basic Information
Standard Code:
YY 0503-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Disinfection equipment
Publish Date:
2023-06-20
Implement Date:
2025-07-01
Publisher:
国家药品监督管理局
Technical Committee:
全国消毒技术与设备标准化技术委员会(SAC/TC 200)
Pages:
28 pages
Scope
本文件规定了环氧乙烷灭菌器(以下简称灭菌器)的分类、要求，描述了相应的试验方法。本文件适用于采用环氧乙烷气体(无论是纯环氧乙烷气体还是与其他气体的混合物)作为灭菌剂的自动控制型灭菌器。灭菌器可用于医疗器械工业生产灭菌和医疗机构中的灭菌。本文件不适用于直接将环氧乙烷或含有环氧乙烷的混合物注入包装或柔性腔内的灭菌方式及设备。本文件未规定灭菌器的压力容器要求，也未规定环氧乙烷灭菌中产生的废气、废水等废弃物处理要求和环氧乙烷残留量。注：若灭菌器的箱体符合特种设备中压力容器的定义，灭菌器需要满足压力容器相应法规的要求。
Development Information
Replace the following standards
Referenced Standards
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 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1:General requirements
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.2-2015 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes
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 19971-2005 Sterilization of health care products—Vocabulary
GB/T 19971-2015 Sterilization of health care products—Vocabulary
YY/T 0698.4-2009 Packaging materials for terminal sterilized medical devices—Part 4:Paper bags—Requirements and test methods
YY/T 0698.5-2009 Packaging materials for terminal sterilized medical devices—Part 5:Heat and self-sealable pouches and reels of paper and plastic film construction—Requirements and test methods
YY/T 0698.5-2023 Packaging materials for terminal sterilized medical devices—Part 5:Sealable pouches and reels of porous materials and plastic film construction—Requirements and test methods
GB/T 18281.2-2024 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes
GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements
GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
GB/T 19971-2026 Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards
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