This standard specifies the classification, basic parameters, technical requirements, test methods, inspection rules, marking, packaging, transportation and storage requirements for fiber upper gastrointestinal endoscopes. This standard applies to fiber upper gastrointestinal endoscopy series products, which are used for examination, diagnosis or treatment of the esophagus, stomach and duodenum.
YY 1028-2008 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 14233.1-1998 Infusion, transfusion, injection equipment for medical use--Part 1: Chemical analysis methods
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
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 191-2008 Packaging.Pictorial marking for handling of goods