ISO 25539-2 PDF

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 results shall be evaluated in relation to the force s necessary to withdraw the system. Alternative methodology might need to be developed to appropriately evaluate this attribute for such devices.

Tests were then identified to address each of the failure modes. NOTE This test is not designed to evaluate the entire system; however, the system is required to deploy the stent that is under test.

For quantitative data, the maximum, minimum, mean and standard deviation shall be included. Also record any anomalous observations e. Neurological dysfunction due to inadequate detoxification of the blood by the liver. For estimating risks, the hazards to be considered include, but are not limited to, the following: For those tests performed simultaneously, the report should provide the individual test results for each of the tests listed in the body of this part of ISO?

Determine the appropriate dimensions of the stent coating for conformance with design specifications. CH Geneva 20 Tel. Whether or not successful stent deployment was achieved should be documented.

BS EN ISO 25539-2:2012

A informative Attributes of endovascular devices — Vascular stents — Technical and clinical consideration The following items shall be considered uso evaluating stent durability: For example, fretting corrosion should be evaluated for stents that may be used in an overlapped condition. It might be necessary to conduct an analysis to identify the size s of the device with the greatest potential for failure.

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The volume of blood lost during the procedure should be determined from the procedure report.

The degree of narrowing and imaging modality should be specified. The frequency of the test shall be such that the 25593-2 of the stent under test is no less than the deformation of the stent under the determined physiological conditions.

Occlusion of flow within the target or other vessel which was previously documented to be patent with antegrade flow. Safety factors can be expressed based on stress, strain or fatigue life.

BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents

It was recognized during the drafting of these test methods that they should be combined to reflect the manner in which this testing is often conducted. For test method A only. The degree of narrowing, the timing of the thrombosis in relation to the procedure, and imaging modality should be specified. Stent integrity Coating particulate generation 8. Use of a compliant model should be considered.

ISO copyright office Case postale 56? Endovascular prostheses — Part? Patency Determine the percent 2553-2 of the stent outer 8. Justification and clinical applicability of acceptance criteria for each test shall be provided.

The need for contrast to be able to pass through the lumen of the guide catheter or introducer with the stent system in place should be considered. Stent integrity Component dimension compatibility 8. Requirements for development, validation and routine control of a sterilization process for isk devices ISO?

Evaluate the potential for displacement of the guidewire from its intended position during the advancement of the stent system, as appropriate for the intended use of the stent. Patient selection and exclusion criteria shall be clearly established.

The stent sizes selected for testing shall represent the worst case combination s of diameter and length for each test. All applicable steps of the deployment process will be evaluated. Determine the longitudinal bond strength between parts of the delivery system. Implantation shall be consistent with the recommended instructions for clinical use, as far as permitted by the limitations of the animal model, including overlap of stents, if applicable.

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Results uso be analysed with respect to available preclinical in vivo and clinical performance. This minor revision updates the normative references and provides minor editorial changes to Clause? Evaluate the susceptibility of the stent to corrosion in a simulated physiological environment.

Might be due to twisting or kinking of the stent, failure of the stent to fully open, dissection or any other cause. The stent shall be free of defects that would render the stent unsuitable for its intended use. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. If not all stent sizes and configurations are evaluated, the size s and configurations to be evaluated shall be selected to represent the greatest potential for fatigue failure, so that conclusions regarding the acceptable durability can be reasonably applied to other sizes and configurations not tested.

E informative Supplement to fatigue durability test analytical approach Biocompatibility should be tested in accordance with ISO? Justify the type of elastomeric tubing used, if applicable. Note timing in relation to procedure. These hazards might result in reportable clinical events, including, but not limited to, the following: Angina Arrhythmia Chest, neck, arm or other pain related to decreased coronary blood flow.

ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

These data can be reported in tabular or graphical format. To ensure consistency in the testing of devices, use of the methods in this annex is recommended. A informative Attributes of endovascular devices — Vascular stents — Technical and clinical consideration Tables?