YY/T 0860-2011 Active Industry standards-Medicine

YY/T 0860-2011 Radio frequency ablation instrument for cardiac application

YY/T 0860-2011 Radio frequency ablation instrument for cardiac application

Publish Date: 2011-12-31 Implement Date: 2013-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0860-2011

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: 2011-12-31

Implement Date: 2013-06-01

Pages: 16 pages

Scope

This standard specifies the terms and definitions, components, requirements, test methods, markings, labels, user manuals, packaging, transportation, and storage of cardiac radiofrequency ablation therapy equipment.
This standard applies to the cardiac radiofrequency ablation therapy equipment defined in 3.1 (hereinafter referred to as the equipment), which is used for cardiac interventional radiofrequency ablation surgery.

Development Information

Word Count: 18 Thousand words Pages: 16 pages

Superseded by the following standards

YY/T 0860-2024 Radio frequency ablation instrument for cardiac application

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 GB 9706.15-2008 Medical electrical equipment—Part1:General requirements for safety—1.Collateral standard:Safety requirements for medical electrical systems GB/T 14710-2009 Environmental 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 16886.1-2011 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 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 19633-2005 Packaging for terminally sterilized medical devices 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 0778-2010 Radio frequency ablation catheter YY 91057 GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods 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

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