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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2539-2 Visibility is significantly affected by variations in equipment and parameter settings. A that might be included in the information supplied by the manufacturer. Evaluate the ability of any seal or valves in the delivery system to maintain an adequate haemostatic seal when used with appropriate accessory devices.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
Determine the amount of drug on the stent. If alternative methods are employed, these methods should be justified. Development of acute or chronic ischemia within 30 days of the procedure. The report shall include a description of the anatomical model used, including the geometry and material of construction. Inability to use an accessory device as intended due to mechanical failure or patient anatomy. Evaluate MRI safety and compatibility.
All animals shall undergo post-mortem examination, including those that expire prior to scheduled termination. Further information is contained in tabular form in Annex? Appropriate confidence and reliability parameters should be used for determining RBP. Type and intervals of interim assessments shall be specified and justified.
A informative Attributes of endovascular devices — Vascular stents — Technical and clinical consideration Biocompatibility Assessment of haemostasis 8. Might be due to twisting or kinking of the stent, dissection, or any other cause.
BS EN ISO 25539-2:2012
The investigation shall be carried out using ISO? International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. Whether or not successful stent deployment was achieved should be documented.
Determine the size and amount of particles generated from the coating when subjected to simulated in vivo conditions.
Report whether or not the stent recovers its original geometry after testing. The stent shall have satisfied appropriate preclinical testing requirements of this part of ISO?
The results shall be 255399-2 in relation to the force s necessary to withdraw the system. Isi addition, the following shall be taken into account: NOTE Four tests are listed below, which determine forces related to the deformation of the stent.
The aneurysm size and imaging modality should be specified in all cases. Local, regional down-streamand systemic toxicities should be assessed.
Injury to adjacent structures associated with vascular trauma see definition below. The stent shall be free of defects that would render the stent unsuitable for its intended use. Evaluation and testing within a risk management process ISO? Cystic accumulation of lymph or groin wound drainage occurring at an incision site if used for access. The packaging shall conform to ISO? Procedure related uso which 52539-2 after the patient leaves the procedure room 255399-2 in the need for blood transfusion.
Longitudinal movement of all or part of a stent resulting in clinical symptoms. Report whether permanent deformation is observed and the radius at which permanent deformation is observed. All bonds shall remain intact ieo recommended conditions of use. Publication as an International Standard requires approval by at least 75?
Determine clinically relevant radius of curvature that the implant can accommodate without kinking. This pressure should not exceed the RBP. In particular, preclinical testing should provide data pertaining to safety. D and E provide informative methodology for performing bench and analytical testing. Requirements for materials, sterile barrier systems and packaging systems?
In some cases in this annex, one or more of the methods for the tests identified in the body of this part of ISO? Time of occlusion and imaging modality should be specified. If a tolerance is specified, the lesser value of the respective percentages shall be used. Safety studies of drug-eluting stents should include assessment of dose-dependent effects, including the effect of overdosing e.
The relevant design evaluation sections of this part of ISO? 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. Determine the amount of drug that elutes over the desired time period. NOTE 2 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: A specific question or set of questions shall be defined prospectively.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
A informative Attributes of endovascular devices — Vascular stents — Technical and clinical consideration Tables? The orientation of the stent 2539-2 load application shall be justified. Testing shall include the following items listed in 8. Appropriate testing shall be conducted as deemed necessary.