GB 12259-1990
Abolished
YY 0897-2013
Active
Industry standards-Medicine
YY 0897-2013 Radio-frequency ablation equipment for ear,nose and throat
YY 0897-2013 Radio-frequency ablation equipment for ear,nose and throat
Basic Information
Standard Code:
YY 0897-2013
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:
2013-10-21
Implement Date:
2014-10-01
Pages:
12 pages
Scope
This standard specifies the terms and definitions, components, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of ENT radiofrequency ablation devices.
This standard applies to ENT radiofrequency ablation devices (hereinafter referred to as "devices") as defined in 3.1.
This standard does not apply to high-frequency electrocautery devices.
Development Information
Superseded by the following standards
Referenced Standards
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
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 91057
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB 7543-1996 Rubber surgical gloves
GB 7543-2006 Single-use sterile rubber surgical gloves
GB/T 7543-2020 Single-use sterile rubber surgical gloves
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 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
YY 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
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