GSO ASTM F3036:2021

Standard Guide for Testing Absorbable Stents


 

 

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标准号
GSO ASTM F3036:2021
发布
2021年
发布单位
GSO
当前最新
GSO ASTM F3036:2021
 
 
适用范围
1.1 This Guide covers select physical and mechanical characterizations of vascular stents with one or more absorbable components. Such absorbable stents (also referred to as vascular scaffolds) are used to provide temporary luminal support of the coronary and peripheral vasculature following interventional revascularization procedures. This Guide covers devices that are fabricated from one or more degradable polymers and/or metals (from this point on referred to as “absorbable”). This Guide provides a framework for evaluating the change in select physical and mechanical characteristics of absorbable stents from manufacture through their intended degradation in vivo. Specific testing recommendations are limited to existing ASTM standards for stent evaluation. 1.2 Recommendations specific to non-absorbable stents with absorbable coatings are not within scope. 1.3 Recommendations specific to testing absorbable stent grafts are not provided here, however this standard has many elements applicable to testing absorbable stent grafts.

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