GB 15979-2002
Replaced
YY/T 0646-2022
Active
Industry standards-Medicine
YY/T 0646-2022 Small steam sterilizers
YY/T 0646-2022 Small steam sterilizers
Basic Information
Standard Code:
YY/T 0646-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Disinfection equipment
Publish Date:
2022-05-18
Implement Date:
2023-06-01
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:
43 pages
Scope
本文件规定了小型压力蒸汽灭菌器(以下简称灭菌器)的灭菌周期类型、要求、试验方法、检验规则。
本文件适用于由电加热产生蒸汽或外接蒸汽,灭菌室侧向开口、容积小于60 L且不能装载一个灭菌单元(300 mm×300 mm×600 mm)、额定工作压力不大于0.25 MPa且预设的灭菌温度在115 ℃~138 ℃范围内的自动控制型小型压力蒸汽灭菌器。
注: 在本文件中所提及的压力,除注明为绝对压力外,均指表压。
本文件不适用于立式压力蒸汽灭菌器、手提式压力蒸汽灭菌器、卡式蒸汽灭菌器及液体灭菌。
本文件未规定涉及使用风险范围的安全要求,也未规定湿热灭菌的确认和常规控制的要求。
Development Information
Drafting Units:
广东省医疗器械质量监督检验所、山东博科消毒设备有限公司、江阴滨江医疗设备有限公司、宁波甬安医疗器械制造有限公司
Drafting Persons:
周宇新、胡昌明、袁文虎、查士洪、张明兆、黄鸿新
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 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
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 18281.3-2000 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/T 19971-2005 Sterilization of health care products—Vocabulary
GB/T 19971-2015 Sterilization of health care products—Vocabulary
GB/T 19974-2005 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
YY/T 0698.1-2011 Packaging materials for terminal sterilized medical devices—Part 1:Co-extrusion plastic films used for vacuum forming packaging—Requirements and test methods
YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods
YY/T 0698.2-2022 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods
YY/T 0698.3-2009 Packaging materials for terminal sterilized medical devices—Part 3:Paper for use in the manufacture of paper bags(specified in YY/T 0698.4)and in the manufacture of pouches and reels(specified in YY/T 0698.5)—Requirements and test methods
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
YY/T 0698.6-2009 Packaging materials for terminal sterilized medical devices—Part 6:Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation—Requirements and test methods
YY/T 0698.7-2009 Packaging materials for terminal sterilized medical devices—Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation—Requirements and test methods
YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices—Part 8:Re-usable sterilization containers for steam sterilizers—Requirements and test methods
YY/T 0698.9-2009 Packaging materials for terminally sterilized medical devices—Part 9:Uncoated nonwoven materials of polyolefines for use in the manufacture of sealable pouches,reels and lids—Requirements and test methods
YY/T 0698.10-2009 Packaging materials for terminally sterilized medical devices—Part 10:Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches,reels and lids—Requirements and test methods
GB/T 18281.3-2024 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization processes
GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements
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
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