YY/T 0663.2-2024 in English

Scope

This document specifies the general requirements, expected performance, design attributes, materials, design evaluation, post-market surveillance, production, sterilization, and packaging requirements for stent systems (vascular stents and delivery systems). This document applies to vascular stents (including absorbable vascular stents) for the treatment of vascular stenosis or other vascular abnormalities or lesions. This document applies to stents used in combination with endovascular prostheses to complete the treatment of lesions, including bridging stents (for example, stents placed in the renal artery after release of a fenestrated endovascular prosthesis), but does not describe the use of these stents in combination. Test Methods. This document applies to vascular stents with surface modifications (e.g., drugs and/or other coatings). This document applies to balloons included in stent systems. This document includes positioning devices, coil support devices, and flow-directing devices for local treatment of post-angioplasty dissection, but does not provide a comprehensive description of the requirements and testing of these devices. This document applies to drug-eluting stents but does not provide a comprehensive description of the drug-eluting characteristics of these devices. This document applies to absorbable stents and absorbable-coated stents but does not provide a comprehensive description of the absorbable properties of these devices. This document applies to coated stents and coated stent systems but does not provide a comprehensive description of coating properties. This document does not apply to procedures and devices prior to vascular stenting, such as balloon angioplasty devices. This document does not apply to the requirements and evaluation of living tissue and non-living biomaterials used in the manufacture of vascular stents.