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 type of reaction should be documented. The design of the probe e. The duration of ventilator support should be reported. The results shall be evaluated in relation to the torque necessary to withdraw the system.
Additional testing or analyses should be considered to evaluate the effect of angulation on this parameter, as appropriate. 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: Determine the relationship between stent length and expanded stent diameter. The stent sizes selected for testing shall represent the worst case combination s of diameter and length for each test.
The need for contrast to be able to pass through the lumen of the guide catheter with the stent system in place should be considered. These corrosion mechanisms can include pitting, fretting, crevice and galvanic corrosion. Tests were then identified to address each of 255399-2 failure modes. Ability to access Trackability Tubing tensile strength Determine the strength of the tubing used in the delivery system as appropriate to the material ISO?
These hazards might result in reportable clinical events, including, but not limited to, the following: Might be due to twisting or kinking of the stent, dissection, or any other cause. The potential coating failure mode that might 255339-2 identified by this test includes disruption of the coating, such as delamination, creation of flaps or bare spots and cracking.
Rise in creatinine greater than 25? Samples should be subjected to conditions that are normally encountered and that might affect the test results.
D informative Test methods D. These hazards might result in reportable clinical events, including but not limited to the following: In cases where different metals might be in contact by virtue of the device design or IFU, they shall be in similar contact during evaluation e.
Evaluate the ability of the stent system to advance through the vessel to the target site using the recommended accessories. Examples of delivery systems include balloon catheters or mechanically activated systems. NOTE Four tests are listed below, which determine forces related to the deformation of the stent. Requirements are specified in other related International Standards. Record the largest radius and location at which a kink or stent diameter reduction is observed.
Determine the appropriate dimensions for conformance with design specifications. The report shall include a description of the anatomical isl used, including the geometry and material of construction. The angulation and tortuosity lso the intended stent location and delivery pathway should be considered in the design of the model.
A informative Attributes of endovascular devices — Vascular stents — Technical and clinical consideration Tables? Appropriate testing shall be conducted as deemed necessary. Occlusion of flow within the target or other vessel which was previously documented to be patent with antegrade flow. E informative Supplement to fatigue durability test analytical approach Testing beyond the scope of this part of ISO?
NOTE There are four tests listed below that determine forces related to the deformation of the stent. 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: Cystic accumulation of 25539–2 or groin wound drainage occurring at an incision site if used for access. Infection at percutaneous or surgical access site requiring surgical debridement or vascular repair, and occurring within 30 days of the procedure.
A rationale should be provided for sample selection. Local, regional down-streamand systemic toxicities should be assessed.
Stent integrity Conformability to vessel wall Corrosion?