YY 1028-2008
Upper gastro intestinal fiberscope (English Version)

Standard No.
YY 1028-2008
Language
Chinese, Available in English version
Release Date
2008
Published By
Professional Standard - Medicine
Latest
YY 1028-2008
Replace
YY 91028-1999
Scope
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

YY 1028-2008 history

YY 1028-2008 Upper gastro intestinal fiberscope has been changed from YY 91028-1999 Upper gastro intestinal fiberscope.

Upper gastro intestinal fiberscope



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