GB 12259-1990
Abolished
YY/T 0677-2008
Active
Industry standards-Medicine
YY/T 0677-2008 Liquid nitrogen cryosurgical equipment
YY/T 0677-2008 Liquid nitrogen cryosurgical equipment
Basic Information
Standard Code:
YY/T 0677-2008
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
General requirements for medical equipment
ICS Name:
Treatment equipment
Publish Date:
2008-10-17
Implement Date:
2010-06-01
Pages:
8 pages
Scope
This standard specifies the scope, definitions and terminology, requirements, test methods, inspection rules, and requirements for marking, labeling, and packaging of liquid nitrogen cryogenic surgical treatment equipment.
This standard applies to cryogenic surgical treatment equipment (hereinafter referred to as treatment equipment) that uses liquid nitrogen as a refrigerant and utilizes its latent heat of vaporization for cooling, with a liquid nitrogen storage capacity greater than 1 L. The treatment equipment is primarily used to induce hypothermia in target tissues for purposes such as cryogenic necrosis, cryogenic blockade, inflammatory response, and cryogenic adhesion.
Development Information
Referenced Standards
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
YY 0466-2003 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied
医疗器械说明书、包装标识和标签的管理规定 国家食品药品监督管理局 第10号令
GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
YY/T 0678-2008 Standard performance and safety specification for cryosurgical medical instruments
Related Standards
GB 12261-1990
Abolished
GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator
GB 12262-1990
Abolished
GB 12262-1990 Artificial heart-lung machine—Heat exchanger
GB 2024-1994
Replaced
GB 2024-1994 Acupuncture needles
GB 10035-1994
Replaced
GB 10035-1994 The air-bag type sequential external counter-pulsation device
GB 16174.1-1996
Replaced