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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Evaluate the susceptibility of the stent to corrosion in a simulated physiological environment.
BS EN ISO 25539-2:2012
The volume of blood lost during the procedure kso be determined from the procedure report. Testing has not yet been standardized for the evaluation of the effects of physiological loads beyond radial loading.
Determine the time required to expand the balloon to the maximum recommended inflation pressure, volume or diameter. Data should also be reported as curves of load versus displacement. For example, fretting corrosion should be evaluated for stents that may be used in an overlapped condition. It should be considered as a supplement to ISO? NOTE 2539-2 permanently deformed stents e. The test report for the preclinical in vitro testing should include an executive summary of all testing.
Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. Development of acute or chronic ischemia within 30 days of the procedure. If the intended stent life is less than ten years, shorter duration fatigue testing might be appropriate and shall be justified.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
B isi Bench and analytical tests Table? D and E provide informative methodology for performing bench and analytical testing. Report the maximum, minimum, mean and standard deviation of the load and displacement required to cause clinically relevant buckling or the load at a deflection equivalent to a diameter reduction of at least 50?
Safety factors can be expressed based izo stress, strain 255339-2 fatigue life. The criteria shall specify the target population i. It is the second part of a three-part standard. The definitions of success and failure shall incorporate quantitative values specifically applicable to the imaging modalities or other evaluation techniques to be used in the study.
Tests were then identified to address each of the failure modes. C informative Definitions of reportable clinical events This annex contains examples of clinically reportable events and might not be all inclusive.
Evaluation and testing within a risk management process ISO? The final report shall include current follow-up data on all patients with follow-up as specified by the clinical investigation plan for the last patient enrolled.
The duration of patient follow-up shall be determined in relation to the objectives of the clinical investigation. Additional preconditioning steps might be appropriate for coated stents.
For quantitative data, the maximum, minimum, mean and standard deviation shall be included. Vascular stent Implants cardiovasculaires? For test method B only.
The work of preparing International Standards is normally carried out through ISO technical committees. Evaluate the ability of the implant to maintain adequate contact with the vessel wall. It might be necessary to conduct an assessment to identify the size s of the device with the greatest potential for failure. The izo length to diameter relationship might be affected uso angulation. The results shall be evaluated in relation to the torque necessary to withdraw the system.
The definition of the inflation and deflation end points shall also jso reported.
Ability to deploy Bond strength 8. A clinical investigation shall be carried out for any stent system incorporating design characteristics for which the safety and effectiveness has not been previously demonstrated.
In addition, for drug-eluting stents drug identity testing shall be performed, including 255339-2 identification of impurities and degradants. More than one study can be used to address the specific aims. Stent fracture Fracture or breakage of any portion of the stent.
255339-2 The information provided in each test report should be based upon a prospectively defined test protocol. Report whether or not the stent recovers its original geometry after testing.
Determine the distance between the external diameter of the stent and the external diameter of the balloon while tracking through a tortuous path. Isp stent systems based on these new technologies will need to be evaluated following the basic requirements of this part of ISO? In cases where different metals might be in contact by virtue of the device design or IFU, they 255392 be in similar contact during evaluation e.
Results shall be analysed with respect to available preclinical in vivo and clinical performance. Requirements for materials, sterile barrier systems and packaging systems? Sizing obtained with balloon inflation to the final outer diameter after balloon removal.
A informative Attributes of endovascular devices — Vascular stents — Technical and clinical consideration Tables? The results shall be evaluated in relation to the force s necessary to access the intended location.
NOTE Visibility ixo significantly affected by variations in equipment and parameter settings.