Cardiovascular implants — Endovascular devices — Part 2: Vascular stents This standard has been revised by ISO Abstract ISO specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO , which specifies general requirements for the performance of non-active surgical implants. The scope of ISO includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities.
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Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO , which specifies general requirements for the performance of non-active surgical implants. ISO is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies e.
Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Similarly, specific prosthesis configurations e. ISO is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis.
Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.
Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. ISO is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.
The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices.
Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. ISO does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of endovascular prostheses.
The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.