YY/T 0863-2011 (English Version) PDF

Scope: This standard specifies the requirements for roller-type irrigation and suction devices for medical endoscopes (hereinafter referred to as irrigation and suction devices). This standard applies to roller-type irrigation and suction devices used in endoscopic surgery. This product is used for irrigation and suction during minimally invasive endoscopic surgeries.

YY/T 0863-2011 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 Enviromental requirement and test methods for medical electrical equipment
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
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

2011 YY/T 0863-2011 Medical endoscopes.Endoscope functional supply units.Roller irrigation and suction equipment