YY/T 0872-2013: Test methods for ureteral stents

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Scope

This Standard specifies a referee test method for evaluating the characteristics of disposable
ureteral stents with retention means at both ends, used for short-term drainage of urine from the
kidneys to the bladder. These stents typically have a diameter of 3.7 Fr ~ 14.0 Fr and a length
of 8 cm ~ 30 cm. They are made of silicone rubber, polyurethane, and other polymers, and are
supplied in both non-sterile and disposable sterile forms.
This product may be left in place for extended periods (over 30 d), but this is uncommon and
therefore not covered in this Standard. Similarly, this Standard does not cover ureteral stents
used in non-ureteral applications (such as nephrostomy and ileostomy). Because the effects of
sterilization equipment and processes on stent characteristics vary between hospitals, this
Standard does not apply to non-sterile ureteral stents.

Basic Data

Standard ID	YY/T 0872-2013 (YY/T0872-2013)
Description (Translated English)	Test methods for ureteral stents
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C40
Classification of International Standard	11.040.20
Word Count Estimation	14,162
Quoted Standard	GB/T 528; GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.7; GB/T 16886.8; GB/T 16886.9; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.16; GB/T 16886.17;
Regulation (derived from)	State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the use of ureteral stents disposable test methods for evaluating the characteristics of arbitration fixtures at both ends, these brackets apply to short-term drainage of urine from the kidneys to the bladder hazy. Such stent diame