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 type of reaction should be documented.
The design characteristics of the test article should be verified to be representative of the devices to be released for distribution, including all sizes, configurations and components. This test provides information that might be clinically useful for treatment planning e. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. The use of other technologies for visualization shall be justified.
C includes definitions for the reportable clinical events listed in the table. Stent integrity Torquability 8. These corrosion mechanisms can include pitting, fretting, crevice and galvanic corrosion. Sio This test might also be of importance in evaluating the ability ixo withdraw.
Clinical evidence of pulmonary embolism confirmed by high probability VQ scan, CT scan or pulmonary angiography occurring within 30 days of the procedure. These hazards might result in reportable clinical events, including, but not limited to, the following: An appropriate epidemiological approach shall be utilized for recruiting subjects to minimize bias. Neurological dysfunction due to inadequate detoxification of the blood by the liver. If the intended stent life is less than ten years, shorter duration fatigue testing might be appropriate and shall be justified.
Data should also be reported as curves of load versus displacement. Injury to adjacent structures associated with vascular trauma see definition below.
All animals in the study shall be regularly examined.
Development of a new atrial or ventricular arrhythmia or exacerbation of a prior arrhythmia isi treatment i. A justification for the number of investigational sites shall be provided. The requirements provided in this isi of ISO?
The plate deflection should be reduced by at least 50? The test report shall include the following: Determine the force exerted by a self-expanding stent as a function of the stent diameter. For coated stents, a portion of the underlying substrate should be exposed prior to testing to simulate potential clinical exposure over time. Report whether or not the stent recovers its original geometry after testing.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Patient selection and exclusion criteria shall be clearly established. The length to diameter relationship should be reported in a tabular format, including both absolute values and percentages.
Additional testing or analyses should be considered to evaluate the effect of angulation on this parameter, as appropriate. It shall be readily apparent if the unit container has been opened.
These questions 2553-92 delineate the appropriate end points to be measured and include definitions of success and failure for each end point. A informative Attributes of endovascular devices — Vascular stents — Technical and clinical consideration Tables?
Biocompatibility should be tested in accordance with ISO? For extraction tests, the stent should be tested separately from the delivery system. Conformability of the deployed stent to the? Conditioning might include ixo the stent on or inside the delivery catheter, preconditioning of the stent system as recommended in the instructions for use IFUsingle or multiple passes through an anatomical model, and deployment of the stent.
The need for contrast to be able to pass through the lumen of the guide catheter with the stent system in place should be considered. Lso need for blood transfusion and the volume and source banked, autologous, autotransfused of transfused blood should also be reported.
BS EN ISO 25539-2:2012
A statistical justification for the number of patients studied shall also be provided based upon the clinical hypotheses. The testing shall be conducted at physiological temperature, unless otherwise justified. ISO copyright office Case postale 56? For novel technologies, interim sacrifices and longer implant durations might be indicated. The stent systems based on these new technologies will need to be evaluated following the basic isp of this part of ISO?
The test report for the preclinical in vitro testing shall include an executive summary of all testing.
This summary should include identification of tests, with the rationale for the omission of any tests identified in Annex? The design attributes for vascular stents with or without delivery system are listed in Table?
Vascular stents 1 Scope 1. Results from both expansion and compression shall be reported, with the respective speeds used during testing. Reportable clinical events are defined in Annex? Longitudinal movement of all or part of a stent resulting in clinical symptoms.