YY/T 0864-2011 (English Version) PDF

Scope: This standard specifies the requirements for liquid expansion pumps for medical endoscopes (hereinafter referred to as expansion pumps). This standard applies to expansion pumps used in endoscopic surgery. This product is used for cavity expansion in minimally invasive endoscopic surgery.

YY/T 0864-2011 Referenced Document

GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB 9706.19-2000 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment
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 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 16886.7-2001 Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals
YY 0709-2009 Medical electrical equipment.Part 1-8:General requirements for safety.Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

2011 YY/T 0864-2011 Medical endoscopes.Endoscope functional supply units.Irrigation pump