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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Adverse biological response toxicity to stent coating or drug elution if applicable Aneurysm For true aneurysms: For dated references, only the edition cited applies. The specific syndrome or factor deficiency ies should also be noted. Ability to accurately deploy 8.
Examples include, but are not limited to, extremity, mesenteric and renal ischemia. It is the second part of a three-part standard. A statistical justification for the number of patients studied shall also be provided based upon the clinical hypotheses. Results regarding the compatibility of the recommended accessory devices and the verification of the lumen and outer diameters, if applicable, shall be documented.
Validation requirements for forming, sealing and assembly processes ISO?
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
ISO shall not be held responsible for identifying any or all such patent rights. A table of isk should be provided and pages should be numbered sequentially.
Some requirements in the body of this part of ISO do not have associated test method guidance in this annex, as either lso methodologies have not been standardized or are better addressed by other standards e.
Clinical evidence of pulmonary embolism 2539-2 by high probability VQ scan, CT scan or pulmonary angiography occurring within 30 days of the procedure.
For drug-eluting stents, at least one study should measure drug plasma levels as well as evaluate drug tissue levels, over time.
B or the selection of alternative tests. For test method B only. Determine the force exerted by a self-expanding stent as a function of the stent diameter. Stent integrity Coating dimensions Coating durability 8.
BS EN ISO 25539-2:2012
The fluid used for inflation and the inflation pressure and rate shall be reported. Report the maximum, minimum, mean and standard deviation of the peak force and the diameter at the peak force. The stent design might dictate the need to address functional requirements identified in both ISO?
Using a one-sided tolerance limit for a normal distribution: The length to diameter relationship should be reported in a tabular format, including both absolute values and percentages. Subjective report or documentation of failure to resume the degree of sexual function registered preoperatively, within 6 months of the procedure. Alternative methodology might need to be developed to appropriately evaluate this attribute for such devices.
If the intended stent life is less than ten years, shorter duration fatigue testing might be appropriate and shall be justified. The test report for the preclinical in vitro testing shall include an executive summary of all testing. Conformability of the deployed stent to the?
This second edition cancels and replaces the first edition ISO For coated stents, a portion of the underlying substrate should be exposed prior to testing to simulate potential clinical exposure over time. Sampling shall ensure adequate representation of the expected variability in the manufacture of devices.
Occlusion of flow within the target or other vessel which was previously documented to be patent with antegrade flow. Evaluate the ability of the stent system to provide sufficient rotation to the distal leading end to deliver the stent within the anatomy.
Atelectasis or oso documented by chest X-ray within 30 days of the procedure and requiring treatment with antibiotics, inhalation therapy, intubation or suctioning. For balloons used for balloon-assisted deployment, a lesser reliability might be appropriate. Potential failure modes that might be identified by this test include, but are not limited to, stent fracture due to fatigue and wear or iwo between stents.
Testing shall include the following items in 8. Specific information for stents and stent systems follows.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Determine the relationship between stent length and expanded stent diameter. K SD where K is the factor of a one-sided tolerance limit for a normal distribution K is found in statistical tables and is dependent on P, C and N ; P? Vascular stents — Part?