YY/T 0858-2011 (English Version) PDF

Scope: This standard provides guidance on the quantitative characterization of the compliance of balloon-expandable stents and stent systems using a three-point bending test. This standard is used to characterize the compliance of a released stent and the compliance of the stent and balloon regions in an unreleased stent system. This standard does not apply to samples whose stent span-to-outer diameter ratio is less than 4:l. Such samples can be evaluated using other methods. This standard does not provide procedures for characterizing the bending compliance of self-expanding stents, self-expanding stent systems, endostents (stent-vascular grafts), or endostent systems. However, some elements of this standard may be useful in developing methods for characterization of three-point bending of these products. Although this standard is based on vascular stents and stent systems, this standard can also provide some reference for the characterization of the bending compliance of non-vascular balloon-expandable stents and stent systems. This standard uses the International System of Units. The values in brackets are in inch-pound units and are for reference only.

YY/T 0858-2011 history

2011 YY/T 0858-2011 Standard guide for three-piont bending of balloon expandable vascular stents and stent systems