YY/T 0283-2007 (English Version) PDF

Scope: This standard specifies the classification and labeling, requirements, test methods, inspection rules, signs, instructions for use and packaging, transportation and storage of fiberoptic colorectal endoscopes. This standard applies to fiberoptic colonoscopy (hereinafter referred to as fiberoptic colonoscopy). This product is used for inspection and diagnosis of the human large intestine lumen, and can be used for treatment in conjunction with related surgical systems.

YY/T 0283-2007 Referenced Document

GB 11244-2005 General requirements for the medical endoscope and endoscope accessories
GB 9706.1-1995 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 9706.4-1999 Medical electrical equipment Particular requirements for the safety of high frequency surgical equipment
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
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 191-2000 Packaging-Pictorial marking for handling of goods
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied

YY/T 0283-2007 Large intestine fiber endoscope was changed to YY/T 1028-2023 medical endoscope fiberscope.