Purchase your copy of BS EN ISO as a PDF download or hard copy directly from the official BSI Shop. All BSI British Standards. DIN EN ISO Cardiovascular implants – Endovascular devices – Part 2: Vascular stents (ISO ); German version EN ISO ISO _临床医学_医药卫生_专业资料。INTERNATIONAL STANDARD ISO Second edition Cardiovascular.
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Whether the deficit was permanent or transient should also be reported. In particular, preclinical testing should provide data pertaining to safety. Justification for the selection of tests shall be provided.
In addition, for drug-eluting stents drug identity testing shall be performed, including the identification of impurities and degradants. Evaluate the ability of the balloon to withstand a clinically justified number of repeated inflation cycles to the RBP. Data should also be reported as curves of load versus displacement.
Tests isk then identified to address each of the failure modes.
BS EN ISO 25539-2:2012
Subjective report or documentation of failure to resume the degree of sexual function registered preoperatively, within 6 months of the procedure. The stent design might dictate the need to address functional requirements identified in both ISO? Stent integrity Conformability to vessel wall Corrosion?
Rise in creatinine greater than 25? Adverse biological response toxicity to stent coating or drug elution if applicable Aneurysm For true aneurysms: NOTE This test is not designed to evaluate ido entire system; however, the system is required to deploy the stent that is under 2539-2. Might be due to twisting or kinking of the stent, failure of the stent to fully open, dissection or any other cause. Clinical evidence of pulmonary embolism confirmed by ieo probability VQ scan, CT scan or pulmonary angiography occurring within 30 days of the procedure.
In addition, a form is given to help provide the proper context for the information contained within the matrix. Ability to accurately deploy 8. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, iwo, packaging and information supplied by the manufacturer.
This test provides information that might be clinically useful for treatment planning e.
Results regarding the compatibility of the recommended accessory devices and the verification isp the lumen and outer diameters, if applicable, shall be documented. A justification will be required for follow-up intervals. Develop a test method based on the following: If an appropriate control is not or cannot be identified, or a concurrent control is unnecessary, a method for evaluating the clinical outcomes shall be prospectively defined and justified.
Sio similar, crush resistance with a radially applied load, crush resistance using parallel plates, local compression and radial force tests measure different attributes of the stent, as follows: Atelectasis or pneumonia documented by chest X-ray within 30 days of the procedure and requiring treatment with antibiotics, inhalation therapy, intubation or suctioning. The type of treatment required should be reported.
The results shall be evaluated in relation to isk force s necessary to withdraw the system.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
This pressure should uso exceed the RBP. A clinical investigation shall be carried out for any stent system incorporating design characteristics for which the safety and effectiveness has not been previously demonstrated. Implantation shall be consistent with the recommended instructions for clinical use, as ixo as permitted by the limitations of the animal model, including overlap of stents, if applicable.
The angulation and tortuosity of the intended stent location and delivery pathway should be considered in the design of the model. This outer container shall be designed so as to protect the unit container from damage due to storage.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
MRI safety and compatibility 8. F ,  ASTM? Occlusion of flow within the target or other vessel which was previously documented to be patent with antegrade flow within 30 days of the procedure. Examples include, but are not limited to, extremity, mesenteric and renal ischemia.
Evaluate the performance of the stent system using a model s that simulate s the intended use conditions. It is recognized that not all tests identified in a?
Appreciable portion of stent not in direct contact with the vessel wall. The cause of death or illness, and the extent to which the implant was implicated shall be documented. Determine the amount of drug that elutes over the desired time period.
Other dimensions shall be expressed in millimetres. NOTE 2 Although similar, crush resistance with a radially applied load, crush resistance using parallel plates, local compression and radial force tests measure different attributes of the stent, as follows: A simulated physiological environment e.