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

Publish Date: 2013-10-21 Implement Date: 2014-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 20 Thousand words Pages: 12 pages

Superseded by the following standards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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