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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Inability to use an accessory device as intended due to mechanical failure or patient anatomy. Consideration shall be given to the failure modes of the stent systems and their effects on the performance of the implant in identifying the appropriate testing.
Appropriate testing shall be conducted as deemed necessary. The investigation shall be carried out using ISO?
Stent integrity Torquability 8. If the intended stent life is less than ten years, shorter duration fatigue testing might be appropriate and shall be justified. The fluid used for inflation and the inflation pressure and rate shall be reported.
Justification for the selection of tests shall be provided. A risk assessment shall be carried out and the requirements of ISO? Test samples shall be appropriate to the type of corrosion under evaluation e. 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. D informative Test methods D. Additional testing specific to certain materials e. For drug-eluting stents, real time and accelerated testing conditions should be used to define drug attributes for product shelf life.
Infection at percutaneous or surgical access site not involving the access vessel or deep muscle, and occurring within 30 days of the procedure. The stent shall have satisfied appropriate preclinical testing requirements of this part of ISO? The use of other technologies for visualization shall be justified.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
Determine the force exerted by a self-expanding stent as a function of the stent diameter. The plate deflection should be reduced by 255539-2 least 50? Guidance on corrosion assessment can be found from a variety of sources e. Determine the appropriate dimensions for conformance with design specifications.
BS EN ISO 25539-2:2012
C informative Definitions of reportable clinical events This annex contains examples of clinically reportable events and might not be all inclusive.
If lesser reliability parameters are specified, justification shall be provided for the selection of these parameters. Validation requirements for forming, sealing and assembly processes ISO?
Neurological dysfunction due to inadequate detoxification of the blood by the liver. The testing shall evaluate the suitability of the stent for its intended use in clinical investigation.
A that might be included in the information supplied by the manufacturer. The table headings and explanations are listed in Table? Patient selection and exclusion criteria shall be clearly established. Clinical evidence of pulmonary embolism confirmed by high probability VQ scan, CT scan or pulmonary angiography occurring within 30 days of 255339-2 procedure.
Time of occlusion and imaging modality should be specified. As far as permitted by the limitations of the animal model, all devices used shall be of clinical quality and size, and of the design intended for clinical use. It should be considered as a supplement to ISO?
The test report shall include the following: The sampling should fully represent the 52539-2 of device designs and might not necessarily require the testing of each size.
The stent system should be used for this test if the stent is intended to be mounted on the balloon during inflation. The results shall be evaluated in relation to the force s necessary to access the intended location. Ability to accurately deploy 8. All 255539-2 implanted with either a test or control stent, including those excluded from the final analysis, shall be recorded and reported.