YY 0860-2011 (English Version) PDF

Scope: This standard specifies the terms and definitions, composition, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of cardiac radiofrequency ablation therapy equipment. This standard applies to cardiac radiofrequency ablation treatment equipment (hereinafter referred to as equipment) defined in 3.1, which is used for cardiac interventional radiofrequency ablation procedures.

YY 0860-2011 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 9706.4-2009 Medical electrical equipment-Part2-2:Particular requirements for the safety of high frequency surgical equipment
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 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
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 Packaging.Pictorial marking for handling of goods
GB/T 19633-2005 Packaging for terminally sterilized medical devices
YY 0505 Medical electrical equipment.Part 1-2:General requirements for safety.Collateral standard:Electromagnetic compatibility.Requirements and tests*， 2012-12-17 Update
YY 0778-2010 Radio frequency ablation catheter
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