YY 0325-2016: Sterile urethral catheter for single use

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Scope

This Standard specifies the terms and definitions, requirements, symbols and
markings, packaging, etc. for sterile urethral catheter for single use.
This Standard applies to sterile urethral catheter with balloon and without
balloon for single use.

Basic Data

Standard ID	YY 0325-2016 (YY0325-2016)
Description (Translated English)	Sterile urethral catheter for single use
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	21,261
Date of Issue	2016-03-23
Date of Implementation	2018-01-01
Older Standard (superseded by this standard)	YY 0325-2002
Quoted Standard	GB/T 1962.1; GB/T 14233.1; GB/T 15812.1-2005; GB/T 19633.1; YY/T 0313; YY/T 0466.1; YY/T 0615.1
Regulation (derived from)	Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the terminology and definitions, requirements, symbols and signs, packaging, etc. of disposable sterile catheters. This standard applies to single-use sterilized balloon and non-balloon catheter.