GB 12259-1990
Abolished
YY 0778-2018
Active
Industry standards-Medicine
YY 0778-2018 Radio frequency ablation catheter
YY 0778-2018 Radio frequency ablation catheter
Basic Information
Standard Code:
YY 0778-2018
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Physiotherapy and traditional Chinese medicine instruments and equipment
ICS Name:
Treatment equipment
Publish Date:
2018-12-20
Implement Date:
2020-06-01
Pages:
10 pages
Scope
This standard specifies the terms and definitions, requirements, and test methods for radiofrequency ablation catheters.
This standard applies to surgical accessories used as high-frequency surgical equipment, which can transmit radiofrequency energy to target tissues through blood vessels and cavities to perform cutting and ablation on the target tissues, hereinafter referred to as catheters.
Development Information
Replace the following standards
Referenced Standards
GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings
GB 9706.4-2009 Medical electrical equipment—Part 2-2:Particular requirements for the safety of high frequency surgical equipment
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
YY 0285.1-2017 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements
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
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