GB 15979-2002
Replaced
YY 0646-2008
Replaced
Industry standards-Medicine
YY 0646-2008 Small steam sterilizers—Automatic type
YY 0646-2008 Small steam sterilizers—Automatic type
Basic Information
Standard Code:
YY 0646-2008
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Disinfection equipment
Publish Date:
2008-04-25
Implement Date:
2009-12-01
Pages:
43 pages
Scope
This standard specifies the classification and basic parameters, requirements, test methods, and inspection rules for automatic control type small steam sterilizers. This standard applies to electrically heated or externally connected steam-generating automatic control type small steam sterilizers with a sterilization chamber volume not exceeding 60 L, which cannot accommodate a single sterilization unit (300 mm × 300 mm × 600 mm). This type of sterilizer is mainly used for sterilizing medical supplies or materials and instruments that may come into contact with blood or body fluids. This standard does not apply to the sterilization of sealed liquids. This standard does not stipulate safety requirements related to the scope of use risks, nor does it stipulate requirements for the validation and routine control of moist heat sterilization.
Development Information
Superseded by the following standards
Referenced Standards
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
GB/T 19971-2005 Sterilization of health care products—Vocabulary
ISO 11140-3:2000
EN 13060:2004
特种设备安全监察条例 中华人民共和国国务院(第373号)
压力容器安全技术监察规程 国家质量技术监督局(1999)
GB 150-1998 Steel pressure vessels
GB/T 150.1-2011 Pressure vessels—Part 1:General requirements
GB/T 150.1-2024 Pressure vessels—Part 1:General requirements
GB/T 150.2-2011 Pressure vessels—Part 2:Materials
GB/T 150.2-2024 Pressure vessels—Part 2:Materials
GB/T 150.3-2011 Pressure vessels—Part 3:Design
GB/T 150.3-2024 Pressure vessels—Part 3:Design
GB/T 150.4-2011 Pressure vessels—Part 4:Fabrication,inspection and testing,and acceptance
GB/T 150.4-2024 Pressure vessels—Part 4:Fabrication,inspection and testing,and acceptance
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 1226-2001 General pressure gauge
GB/T 1226-2010 General pressure gauge
GB/T 1226-2017 General pressure gauge
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 12244-1989 General specification for pressure reducing valves
GB/T 12244-2006 General requirements for pressure reducing valves
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 18268-2000 Electrical equipment for measurement, control and laboratory use—EMC requirements
GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
GB/T 18268.21-2010 Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 21:Particular requirements—Test configurations,operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications
GB/T 18268.22-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 22:Particular requirements—Test configurations,operational conditions and performance criteria for portable test,measuring and monitoring equipment used in low-voltage distribution systems
GB/T 18268.23-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 23:Particular requirements—Test configurations,operational conditions and performance criteria for transducers with integrated or remote signal conditioning
GB/T 18268.24-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 24:Particular requirements—Test configurations,operational conditions and performance criteria for insulation monitoring devices according to IEC 61557-8 and for equipment for insulation fault location according to IEC 61557-9
GB/T 18268.25-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 25:Particular requirements—Test configurations,operational conditions and performance criteria for field devices with interfaces according to IEC 61784-1,CP 3/2
GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment
GB/T 18268.31-2022 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 31:Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety)—General industrial applications
GB/T 18268.32-2022 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 32:Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety)—Industrial applications with specified electromagnetic environment
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 0159-2005 Steam trap fitted on pressure steam sterilizer
YY/T 0159-1994 The pressure steam sterilization equipment uses a hydrophobic valve
GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
GB/T 18268.22-2025 Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 22:Particular requirements—Test configurations, operational conditions and performance criteria for portable testing, measuring and monitoring equipment used in low-voltage distribution systems
GB/T 18268.21-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 21:Particular requirements—Test configurations,operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
GB/T 12244-2025 Pressure reducing valves—General requirements
GB/Z 150-2025 Guide for magnetizing behaviour of permanent magnets
Adopt standards
EN 13060:2004
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 0215-2008
Replaced
YY 0215-2008 Medical ozone disinfecting cabinets
YY 0679-2008
Replaced