YY 1075-2007: Rigid hysteroscope

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Scope

This standard specifies the classification and marking, requirements, test
methods, inspection rules, signs, labels and instructions for use, packaging,
transportation, storage of rigid hysteroscope.
This standard applies to rigid hysteroscope (hereinafter referred to as
hysteroscope). Hysteroscope is mainly used in the medical clinical diagnosis of
uterine cavity disease and treatment together with surgery instruments.
This standard does not apply to high-frequency electric hysteroscope.

Basic Data

Standard ID	YY 1075-2007 (YY1075-2007)
Description (Translated English)	Rigid hysteroscope
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C40
Classification of International Standard	11.040.70
Word Count Estimation	17,168
Date of Issue	2007-07-02
Date of Implementation	2008-03-01
Older Standard (superseded by this standard)	YY 91075-1999
Quoted Standard	GB/T 191-2000; GB/T 2829-2002; GB/T 6463-2005; GB 9706.1-1995; GB 9706.19-2000; GB 11244-2005; GB/T 14710-1993; GB/T 16886.1-2001; GB/T 16886.5-2003; GB/T 16886.10-2005; YY 0068; YY 0076-1992; YY 0466-2003
Regulation (derived from)	State Food and Drug Administration Notice 2011 No. 45
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the rigid endoscope intrauterine classification and marking, requirements, test methods, inspection rules, marking, labeling and instructions, packaging, transportation and storage. This standard applies to rigid uterine endoscopy (hereinafter referred to as hysteroscopy). Hysteroscopy is mainly used in clinical medicine for uterine cavity disease diagnosis and treatment with surgical instruments. This standard does not apply to high frequency electric cutting hysteroscopy.