YY 0778-2010 Radio frequency ablation catheter

YY 0778-2018 Radio frequency ablation catheter

GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability) GB/T 4122.1-2008 Packaging terms—Part 1:Basic 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 9706.19-2000 Medical electrical equipment—Part 2:Particular requirements for the safety of endoscopic 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 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood 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 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity YY 0285.1-2004 Sterile,single-use intravascular catheters—Part 1:General requirements YY/T 0033-2000 Good manufacture practice for sterile medical devices YY 0033-2000 Sterile medical device production management regulations