YY 1028-2008: Upper gastro intestinal fiberscope

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Scope

This Standard specifies upper gastro intestinal fiberscope’s classification, basic
parameters, technical requirements, test method, inspection rules, marking, packaging,
transportation and storage requirements.
This Standard applies to upper gastro intestinal fiberscope series products, which are
used for diagnosis or treatment of oesophagus, stomach and duodenum.

Basic Data

Standard ID	YY 1028-2008 (YY1028-2008)
Description (Translated English)	Upper gastro intestinal fiberscope
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C40
Classification of International Standard	11.040
Word Count Estimation	13,15
Date of Issue	2008-10-17
Date of Implementation	2010-06-01
Older Standard (superseded by this standard)	YY 91028-1999
Quoted Standard	GB/T 191-2008; GB 9706.1-2007; GB 9706.19-2000; GB/T 16886.5-2003; GB/T 16886.10-2005; GB/T 14233.1-1998; GB/T 14710-1993
Regulation (derived from)	SFDA [2008] No. 605
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the fiber upper gastrointestinal endoscopy classification, the basic parameters, technical requirements, test methods, inspection rules, marking, packaging, transportation and storage requirements. This standard applies to fiber upper gastrointestinal endoscopy series, the series of products for the esophagus, stomach, duodenum, diagnosis or treatment purposes.