GB 15979-2002
Replaced
YY/T 0679-2025
Pending
Industry standards-Medicine
YY/T 0679-2025 Steam and formaldehyde sterilizers
YY/T 0679-2025 Steam and formaldehyde sterilizers
Basic Information
Standard Code:
YY/T 0679-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Disinfection equipment
Publish Date:
2025-06-18
Implement Date:
2027-01-01
Pages:
44 pages
Scope
This document specifies the type and marking, as well as the requirements, of steam formaldehyde sterilizers (hereinafter referred to as sterilizers), and describes the corresponding test methods.
This document is applicable to sterilizers that use a mixture of steam and formaldehyde gas to sterilize heat-sensitive medical items.
Development Information
Replace the following standards
Referenced Standards
GB/T 1914-1993 Chemical analytical filter paper
GB/T 1914-2007 Chemical analytical filter paper
GB/T 1914-2017 Chemical analytical filter paper
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/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
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 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/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements
GB 18281.5-2015 Sterilization of health care products—Biological indicator—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes
GB/T 18281.5-2024 Sterilization of health care products—Biological indicators—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes
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 19971-2015 Sterilization of health care products—Vocabulary
GB/T 30121-2013 Industrial platinum resistance thermometers and platinum temperature sensors
YY/T 0883-2013 Specification of process challenge devices and indicator systems for steam penetration testing
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