GB 12259-1990
Abolished
YY/T 0776-2010
Replaced
Industry standards-Medicine
YY/T 0776-2010 Radio frequency ablation instrument for liver
YY/T 0776-2010 Radio frequency ablation instrument for liver
Basic Information
Standard Code:
YY/T 0776-2010
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Physiotherapy and traditional Chinese medicine instruments and equipment
ICS Name:
Treatment equipment
Publish Date:
2010-12-27
Implement Date:
2012-06-01
Pages:
16 pages
Scope
This standard specifies the definition, composition, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of liver radiofrequency ablation treatment equipment.
This standard applies to the liver radiofrequency ablation treatment equipment defined in 3.1 (hereinafter referred to as the equipment), which is used for the ablation treatment of solid tumors in the liver.
Development Information
Referenced Standards
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.4-2009 Medical electrical equipment—Part 2-2:Particular requirements for the safety of high frequency surgical equipment
GB 9706.15-2008 Medical electrical equipment—Part1:General requirements for safety—1.Collateral standard:Safety requirements for medical electrical systems
GB 9706.19-2000 Medical electrical equipment—Part 2:Particular requirements for the safety of endoscopic equipment
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 16273.1-2008 Graphical symbols for use on equipment—Part 1:Common symbols
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 19633-2005 Packaging for terminally sterilized medical devices
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY 91057
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