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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In addition, the following shall be taken into account: Clinically significant, unplanned occlusion or obstruction of a major branch vessel. It was recognized during the drafting of these test methods that they should be combined to reflect the manner in which this testing 25593-2 often conducted.
BS EN ISO 25539-2:2012
Results regarding the compatibility of the recommended iao devices and the verification of the lumen and outer diameters, if applicable, shall be documented. The results shall be evaluated in relation to the torque necessary to withdraw the system. The test report for the preclinical in vitro testing should include an executive summary of all testing. Subjective report or documentation of failure to resume the degree of sexual function registered preoperatively, within 6 months of the procedure.
No tube is necessary for semi- and non-compliant balloon testing. These events might not have clinical significance and might not be attributable to the device.
It should be considered as a supplement to ISO? The following items shall be considered in evaluating stent durability: Additional preconditioning steps might be appropriate for coated stents.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Validation requirements for forming, sealing and assembly processes ISO? A justification for the number of investigational sites shall be provided. Evaluate the long-term dimensional and structural integrity of the stent and any coating.
These hazards might result in reportable clinical events, including but not limited to the following: Alternative methodology might need to be developed to appropriately evaluate this attribute for such devices.
This pressure should not exceed the RBP. For all tests, the number of samples shall be justified. Evaluate the ability of any seal or valves in the delivery system to maintain an adequate haemostatic seal when used with appropriate accessory devices.
Adverse biological response toxicity to stent coating or drug elution if applicable Aneurysm For true aneurysms: B or the selection of alternative tests.
Might be due to twisting or kinking of the stent, dissection, or any other cause. The calculation of the number of patients to be enrolled shall take account of the effect of comorbidities on the life expectancy of the patient population.
Individual test reports should include the following information: Also record any anomalous observations e. The criteria shall specify the target population i.
Consideration shall be given to the anatomical, physiological, and morphological conditions of the intended use in establishing the acceptance criteria.
Each corrosion mechanism should be evaluated for specific stent designs, as appropriate. 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: Development of a new atrial or ventricular arrhythmia or exacerbation of a prior arrhythmia requiring treatment i. The volume of blood lost during the procedure should be determined from the procedure report.
Stent integrity Conformability to vessel wall Corrosion? Vascular stent Implants cardiovasculaires? It is impossible to take into consideration all future and emerging technologies.
Samples should be subjected to conditions that are normally encountered and that might affect the test results. Testing shall include the following items in 8.
A table of contents should be provided and pages should be numbered sequentially. Determine the appropriate dimensions of the stent coating for conformance with design specifications.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
Interpretation of animal study results can be enhanced by the use of at least a small number of control devices for comparison purposes. Results from the testing and the analyses to evaluate the durability of the stent are complementary and should be interpreted both independently and in combination. The test report for the preclinical in vitro testing shall include an executive summary of all testing. Evaluate the performance of the stent system using a model s that simulate s the intended use conditions.
Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee.