YY 0776-2010
Radio frequency ablation instrument for liver (English Version)

Standard No.

YY 0776-2010

Language

Chinese, Available in English version

Release Date

2010

Published By

Professional Standard - Medicine

Latest

YY 0776-2010

Scope

This standard specifies the definition, composition, requirements, test methods, inspection rules, marking, packaging, transportation and storage of liver radiofrequency ablation therapy equipment. This standard applies to liver radiofrequency ablation therapy equipment (hereinafter referred to as equipment) defined in 3.1, which is used for ablation treatment of liver solid tumors.

YY 0776-2010 Referenced Document

• GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
• GB 9706.15-2008 Medical electrical equipment.Part 1: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 9706.4-2009 Medical electrical equipment-Part2-2:Particular requirements for the safety of high frequency surgical 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 Enviromental 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 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
• GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
• GB/T 191-2008 Packaging.Pictorial marking for handling of goods
• GB/T 19633-2005 Packaging for terminally sterilized medical devices
• YY 0505-2005 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
• YY 91057 General specifications for medical foot switch
• 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 0776-2010 history

• 2010 YY 0776-2010 Radio frequency ablation instrument for liver