GB 12259-1990
Abolished
YY/T 0860-2024
Active
Industry standards-Medicine
YY/T 0860-2024 Radio frequency ablation instrument for cardiac application
YY/T 0860-2024 Radio frequency ablation instrument for cardiac application
Basic Information
Standard Code:
YY/T 0860-2024
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:
2024-09-29
Implement Date:
2025-10-15
Pages:
16 pages
Scope
This document specifies the classification and requirements of cardiac radiofrequency ablation therapy equipment (hereinafter referred to as the equipment) and its accessories, and describes the corresponding test methods.
This document applies to cardiac radiofrequency ablation therapy equipment and its accessories. This type of equipment is used in cardiac interventional radiofrequency ablation surgery or cardiac/thoracic surgery radiofrequency ablation surgery.
Development Information
Replace the following standards
Referenced Standards
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 9706.202-2021 Medical electrical equipment—Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
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 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
GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
YY 0650-2008 Gynecological radio frequency therapy instrument
YY 0650-2022 General technical requirements for radio frequency ablation equipment
YY 0778-2010 Radio frequency ablation catheter
YY 0778-2018 Radio frequency ablation catheter
YY/T 1057-2016 General specifications for medical foot switch
YY 1057-2016 General specifications for medical foot switch
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
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