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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Fixation effectiveness diameter from the maximum outer diameter 8. This pressure should not exceed the RBP. The volume of blood lost during the procedure 255339-2 be determined from the procedure report. Stent integrity Assessment of biocompatibility 8.
Potential failure modes that might be identified by this test include, izo are not limited to, stent fracture due to fatigue and wear or abrasion between stents. 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 also include the make and model of the imaging equipment, the parameter settings and details of the phantom tissue model. Vascular stents — Part? 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 stent sizes selected for testing should represent the worst case combination s of diameter and length for each test.
Occlusion of flow within the 25593-2 or other vessel which was previously documented to be patent with antegrade flow. Determine the type and purity of the drug and characterize the type and amount of degradants at manufacture and with storage. Determine the force exerted by a self-expanding stent as a function of the stent diameter. Vascular stent Implants cardiovasculaires?
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
It is the second part of a three-part standard. The imaging modality should be specified. The test report shall include the maximum, minimum, mean and standard deviation of all measured dimensions, the results of any verified dimensions, and the results of the observations of the accessory compatibility. As far as permitted by the limitations of the animal model, all devices used shall be of clinical quality and size, 255539-2 of the design intended for clinical use.
Isi questions shall delineate the appropriate end points to be measured and include definitions of success and failure for each end point. Iwo accumulation of lymph or groin wound drainage occurring at an incision site if used for access. The fluid used for inflation and the inflation pressure and rate shall be reported. 25539-22 might be necessary to conduct an assessment to identify the size s of the device with the greatest potential for failure.
Some requirements in the body of this part of ISO do not have associated test method guidance in this annex, as either the methodologies have not been standardized or are better addressed by other standards e.
While test methods have not yet been standardized, durability testing to fracture has several potential advantages, including identification of failure modes, verification of device fatigue analysis and appropriateness of factor of safety.
It might be necessary to conduct an 255392- to identify the size s of the device with the greatest potential for failure. A rationale should be provided if a control device is not used in the study. Endovascular prostheses — Part? For drug-eluting stents, real time and accelerated testing conditions should be used to define drug attributes for product shelf life.
For those tests performed simultaneously, the report should provide the individual test results for each of the tests listed in the body of this part of ISO? Conditioning might include loading the stent on or inside the delivery catheter, preconditioning of the stent 255539-2 as recommended in the instructions for use IFUsingle or multiple passes through an anatomical model, and deployment 25593-2 the stent.
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, 25593-2 follows: Samples should be subjected to conditions that are normally encountered and that might affect the test results.
Infection at percutaneous or surgical access site not involving the access vessel or deep muscle, and occurring within 30 days of the procedure. Type and intervals of interim assessments shall be specified and justified. For quantitative data, the maximum, minimum, mean and standard deviation shall be included. Whenever changes are made in materials, construction, configuration, application or processing methods, an appropriate analysis of the potential impact of the change on the failure modes and performance of the stent system shall be performed.
Consideration shall be given to the anatomical, physiological and morphological conditions of the intended use in establishing the acceptance criteria. The test fluid shall be identified.
BS EN ISO 25539-2:2012
Occlusion of flow within the target or other vessel which was previously documented to be patent with antegrade flow occurring greater than 30 days following the procedure.
For those tests with specified confidence and reliability parameters, the sample size 255539-2 have a statistical basis. A rationale shall be provided for sample selection.
Evaluate the potential for displacement of the guidewire from its intended position during the advancement of the stent system, as appropriate for the intended use of the stent e. This test is required for stents of a design with the potential for a different response to local compression as compared to a radial or sio plate compressive force and for which this test is clinically relevant. The need for contrast to be able to pass through the lumen of the guide catheter or introducer with the stent system in place should be considered.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Sizing obtained with balloon inflation to the final outer diameter after balloon removal. For novel technologies, interim sacrifices and longer implant durations might be indicated. The results shall be evaluated in relation to the torque necessary to access the system.
Also record any anomalous observations e. Evaluate the ability of the balloon to withstand a clinically justified number of repeated inflation cycles to the RBP.
The sampling should fully represent the range of device designs and might not necessarily require 255539-2 testing of each size. If a tolerance is specified, the lesser value of the respective percentage shall be used.
Results shall be analysed with respect to available preclinical in vivo and clinical performance. Data should also be reported as curves of load versus displacement.
Ability to access Torsional bond strength 8. Myocardial infarction documented by the presence of raised cardiac enzymes within 30 days of the procedure.