Endovascular devices. Vascular stents BS EN ISO has been prepared in order to provide minimum requirements for endovascular devices and the methods of test that will enable their evaluation. It is the second part of a proposed three-part standard. Those using the arterial stent standard EN should be aware that it will no longer give presumption of conformity to the Medical Devices Directive as of 21 March
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Endovascular devices. Vascular stents BS EN ISO has been prepared in order to provide minimum requirements for endovascular devices and the methods of test that will enable their evaluation.
It is the second part of a proposed three-part standard. Those using the arterial stent standard EN should be aware that it will no longer give presumption of conformity to the Medical Devices Directive as of 21 March Vascular stents. The date of withdrawal coincides with the enforcement date of the amended MDD and will impact any medical devices manufacturers that CE mark their products. Tests were then identified to address each of the failure modes.
The requirements provided in this part of ISO are based on that assessment. This part of 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.
Endovascular devices: Part 1: Endovascular prostheses Part 2: Vascular stents Due to the variations in the design of implants covered by this part of ISO and in some cases due to the relatively recent development of some of these implants e. As further scientific and clinical data become available, appropriate revision of this document will be necessary. The scope of this part of ISO includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities.
Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO The stent design might dictate the need to address functional requirements identified in both ISO and this part of ISO Delivery systems are included in this part of ISO if they comprise an integral component of the deployment of the vascular stent.
Procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices, are excluded from the scope of this part of ISO Some pharmacological aspects of drug eluting stents are addressed in this part of ISO , but this document is not comprehensive with respect to the pharmacological evaluation of drug eluting stents.
Degradation and other time-dependent aspects of bioabsorbable and polymeric stents and coatings are not addressed by this part of ISO With the exception of sterilization, BS EN ISO does not address requirements for the evaluation of animal tissue products. An informative annex has been added to cover the relationship with the EU Directive.
For test method B only. This test is not intended to fully evalua. Ability to withdraw 8. ISO — Cardiovascular implants — Endovascular devices — Part 2: Vascular stents Evaluate the ability of the implant and stent system to bend in order to accommodate the predetermined clinically relevant radius or angle it will be required to negotiate during access and delivery. Results from the testing and the analyses to evaluate the durability of the stent are complementary and should be interpreted both independently and in combination. Stent integrity Conformability to vessel wall Corrosion? Justification shall be provided for the properties not measured.
BS EN ISO 25539-2:2009