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 systems based on these new technologies will need to be evaluated following the 2553-92 requirements of this part of ISO? The following stent types are within the scope of this part of ISO? K SD where K is the factor of a one-sided tolerance limit for a normal distribution K is found in statistical tables and is dependent on P, C and N ; P? Justification shall be provided for the properties not measured. Evaluate the ability of the implant to maintain adequate contact with the vessel wall.
It might be necessary to conduct an analysis to identify the size s of the device with the greatest potential for failure. Requirements for materials, sterile barrier systems and packaging systems? 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. The use of other technologies for visualization shall be justified. Haemostasis Balloon deflation time Balloon isso time 8.
These isso mechanisms can include pitting, fretting, crevice and galvanic corrosion. B informative Bench and analytical tests C includes definitions for the reportable clinical events listed in the table. Adverse biological response toxicity to stent coating or drug elution if applicable Aneurysm For true aneurysms: 25539- should be tested in accordance with ISO?
The testing shall be conducted in an appropriate test solution, such as phosphate buffered sio, unless testing in a different environment, such as distilled water, can be justified. Testing has not yet been standardized for the evaluation of the effects of physiological loads beyond radial loading.
Evaluate MRI safety and compatibility. Interpretation of animal study results can be enhanced by the use of at least isso small number of control devices for comparison purposes.
BS EN ISO 25539-2:2012
Devices to be tested should represent worst-case deployment force conditions e. Determine the relationship between stent length and expanded stent diameter. 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. The control should be appropriate to the questions being addressed in the study.
Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO? Record the largest radius and location at which a kink or stent diameter reduction is observed.
Evaluate the ability of the ieo system to provide sufficient rotation to the distal leading end to deliver the stent within the anatomy. The type of reaction should be documented. The need for and the duration of dialysis, if required, should also be reported. If a tolerance is specified, the lesser value of the respective percentages shall be used. Vascular stent Implants cardiovasculaires?
Evaluate the dimensions of the stent delivery system for compatibility with the dimensions of recommended accessories. Whether or not the failure contributed to an unsuccessful stent deployment should be documented. This test provides information that might be clinically useful for treatment planning e. Determine the force exerted by a self-expanding stent as a function of the stent diameter. The packaging shall conform to ISO?
The table headings and explanations are listed in Table? The relevant design evaluation section of this part of ISO?
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. A informative Attributes of endovascular devices — Vascular stents — Technical 25593-2 clinical consideration Validation requirements for forming, sealing and assembly processes ISO? Sampling shall ensure adequate representation of the expected variability in the manufacture of devices.
The results shall be evaluated in relation to the torque necessary to withdraw the system. Conformability of the deployed stent to the? A simulated physiological environment e. Testing to fracture shall 25539- considered, but is not a requirement.
NOTE When selecting the test fixture, consideration should be given to the width or area under study, the effects of friction and the oso of the fixture geometry on the measured loads. Information should include recommendations or specifications for accessory devices Wire not crossing the lesion Introducer and delivery system not matching the access site i.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
More than one study can be used to address the specific aims. For false pseudo aneurysms: B or the selection of alternative tests. The instructions shall include the following: Determine the maximum diameter along sections of the stent system. Justification and clinical applicability of acceptance criteria for each test shall be provided.