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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The stent shall be free of defects that would render the stent unsuitable for its intended use. Safety factors can be expressed based on stress, strain or fatigue life. For example, Nitinol materials dependent on shape memory properties shall be subjected to testing in order to assess transformation properties.
A rationale should be provided for sample selection. NOTE 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: The packaging shall conform to ISO? Thrombus in a deep vein documented by duplex scanning, venography, or other imaging technique. Whether or not successful stent deployment was achieved should be documented.
Data should also be reported as a curve of load versus diameter for the range of diameters tested. Individual test reports should include the following information: Determine the time required to expand the balloon to the maximum recommended inflation pressure, volume or diameter.
Ability to access Torsional bond strength 8. Use of a compliant model should be considered. Justification for the selection of tests shall be provided. Stent integrity Conformability to vessel wall Corrosion?
The test report shall include the maximum, minimum, mean and standard deviation of all measured dimensions, the results of any verified dimensions, and the results of the observations of the accessory compatibility.
The stent design might dictate the need to address functional requirements identified in both ISO and this part of ISO? Procedure related bleeding which occurs after the patient leaves the procedure room resulting in the need for blood transfusion.
The cause of death or illness, and the extent to which the implant was implicated shall be documented. B includes a list of the bench tests identified in the table, with a description of the purpose of each test, and Annex?
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. All animals in the study shall be regularly examined. The test report shall include the following: The Bibliography includes a partial list of references regarding corrosion terminology, equipment, test procedures and methods.
It is recognized that sio all tests identified in a? Examples include, but are not limited to, extremity, mesenteric and renal ischemia. Evaluate the susceptibility of the stent to corrosion in a simulated physiological environment. Other dimensions 255392 be expressed in millimetres.
BS EN ISO 25539-2:2012
A statistical justification for the number of patients studied shall also be 2553-2 based upon the clinical hypotheses. ISO copyright office Case postale 56? For all tests, the number of samples shall be justified. 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.
Occlusion of flow within the target or other vessel which was previously documented to be patent with antegrade flow occurring greater than 30 days following the procedure.
D and E provide informative methodology for performing bench and analytical testing.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
For extraction tests, the stent should be tested separately from the delivery system. The volume of blood lost during the procedure should be determined from the procedure report. Determine the maximum diameter along sections of the stent system. A table of contents should be provided and pages should be numbered sequentially.
This test provides information that might be clinically useful for treatment planning e. Justification shall be provided for the properties not measured. In addition, for drug-eluting stents drug identity testing shall be performed, including the identification of impurities and degradants.
For dated references, only the edition cited applies. Vascular stents 1 Scope 1. Results from both expansion and compression shall be reported, with the respective speeds used during testing. The test report for the preclinical in vitro testing should include an executive summary of all testing. The criteria shall specify the target population i.