YY/T 0859-2011 in English

Scope

This standard specifies general requirements for finite element modeling and analysis of metallic vascular stents, a finite element analysis method used to evaluate the performance of metallic vascular stent designs under uniform radial loading. This standard provides recommended guidelines for evaluating the typical behavior of metallic vascular stents under uniform radial loading and impulse loading. This standard also provides recommended procedures for validating and validating finite element models. These procedural methods can also be used to evaluate the model itself and the analysis results. Finally, this standard lists the specific content that should be included in such mechanical simulation engineering reports. This standard only applies to the finite element structural analysis of the following types of metal stents: plastically deformed metal stents, self-expanding metal stents, plastically deformed metal parts of covered stents, and metal parts of self-expanding covered stents. The technology introduced in this standard is mainly targeted at elastic-plastic materials (such as stainless steel) and superelastic materials (such as nickel-titanium alloy). This standard does not cover specific content related to the shape memory performance of the stent. This standard does not address conditions that may change over time or load changes associated with revascularization. This standard applies only to uniform radial load conditions. This standard does not provide guidance on finite element analysis with respect to fatigue life. This standard does not include a complete description of the finite element method, its theoretical basis and calculation formulas. This standard uses the International System of Units, and the values in parentheses are for reference only.