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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Ability to accurately deploy 8.
D informative Test methods D. ISO Biological evaluation of medical devices — Part 1: Patient follow-up intervals shall include a minimum of a baseline assessment at discharge and at the end of the clinical evaluation.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The cause of the ischemia should be diagnosed and reported i. Test samples shall be appropriate to the type of corrosion under evaluation e.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
In cases where 25539-2 metals might be in contact by virtue of the device design or IFU, they shall be in similar contact during evaluation e. Development of acute or chronic ischemia within 30 days of the procedure. 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.
Evaluate MRI safety 2539-2 compatibility. If overlapping with a different device is specifically indicated, testing should include evaluation with the indicated device.
Testing beyond the scope of this part of ISO? Reportable clinical events are defined in Annex? The frequency of the test shall be such that the deformation of the stent under test is no less than the deformation of the stent under the determined physiological conditions.
The work of preparing International Standards is normally carried out through ISO technical committees.
Also record any anomalous observations e.
Calculate the mean and standard deviation of the burst pressure. All bonds shall remain intact under recommended conditions of use. All patients implanted with either a test or control stent, including those excluded from the final analysis, shall be recorded and reported. The test report shall include the following: Conformability of the deployed stent to the? A rationale shall be provided for sample selection. Infection at percutaneous or surgical access site requiring surgical debridement or vascular repair, and occurring within 30 days of the procedure.
For test method B only.
Appropriate confidence and reliability parameters should be used for determining RBP. The Bibliography includes a partial list of references regarding corrosion terminology, equipment, test procedures and methods. Develop a test method based on the following: Evaluate the long-term dimensional and structural integrity of the stent and any coating. Sizing obtained with balloon inflation to the final outer diameter after balloon removal. NOTE 1 For permanently deformed stents e. Exceptions for ios control population are noted below: C ; i severity, management, outcome; ii lso of stent system involvement i.
For those tests with specified confidence and reliability parameters, the sample size should have a statistical basis. For false pseudo aneurysms: Patency Force to deploy Local compression Determine the force to deploy the stent from the delivery system. Myocardial infarction documented by the presence of raised cardiac enzymes within 30 days of the procedure. Report whether permanent deformation is observed and the radius at which permanent deformation isoo observed. ISO shall not be held responsible for identifying any or all such patent rights.
Determine the longitudinal bond strength between parts of the delivery system.