ISO 25539-2-2020 pdf free.Cardiovascular implants —Endovascular devices —Vascular stents.
This document specifies requirements for the evaluation of stent systems (vascular stents and deliverysystems) and requirements with respect to nomenclature, design attributes and information suppliedby the manufacturer, based upon current medical knowledge.Guidance for the development of in vitrotest methods is included in Annex D. This document is supplemental to ISO 14630, which specifiesgeneral requirements for the performance of non-active surgical implants.
NOTE1 Due to the variations in the design of implants covered by this document, and in some cases due tothe emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are notalways available.As further scientific and clinical data become available, appropriate revision of this documentwill be necessary.
This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascularscaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies.Some ofthe requirements are specific to endovascular treatment of arterial stenoses. Although uses of stentsystems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of thisdocument, comprehensive requirements and testing are not described for these uses. Similarly, specificstent configurations (e.g.bifurcation stents) are within the scope, but comprehensive requirements andtesting are not described for these devices.
Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion,including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestratedendovascular prosthesis), are within the scope of this document, but test methods are not described forthe combination.ISO 25539-1 also provides information relevant to the preclinical in vivo and clinicalevaluations of such stents.
Vascular stents that have surface modifications, such as drug and/or other coatings, are within thescope of this document. Stents covered with materials that significantly modify the permeability of theuncovered stent (e.g.by covering the stent-free-surface area) are within the scope of ISO 25539-1.Thestent design or intended use might dictate the need to address functional requirements identified inboth lS0 25539-1 and this document (e.g.stents used in combination with endovascular prostheses,stents used to treat aortic aneurysms).
Balloons integral to the stent system are within the scope of this document. This document providesrequirements beyond the requirements of IS0 10555-4, which are specific to the use of balloons withvascular stents.ISO 25539 pdf download.