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 results shall be evaluated in relation to the torque necessary to access the system. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.
MRI compatibility, pharmacokinetics for drug-eluting stents. The volume of replaced blood, the source of the bleeding and whether or not surgical intervention was required to stop the bleeding should also be reported.
D informative Test methods D. Infection at percutaneous or surgical access site not involving the access vessel or deep muscle, and occurring within 30 days of the procedure. Other measurements might be needed to completely verify the dimensions of a particular stent.
Determine the longitudinal bond strength between parts of the delivery system. If not all stent sizes and configurations are evaluated, the size s and configurations to be evaluated shall be selected to represent the greatest potential for fatigue failure, so that conclusions regarding the acceptable durability can be reasonably applied to other sizes and configurations not tested.
This minor revision updates the normative references and provides minor editorial changes to Clause? Additional testing specific to certain materials e.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
For novel technologies, interim sacrifices and longer implant durations might be indicated. C informative Definitions of reportable clinical events Appreciable portion of stent not in direct contact with the vessel wall. Record the largest radius and location at which a kink or stent diameter reduction is observed. 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?
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
These corrosion mechanisms can include pitting, fretting, crevice and galvanic corrosion. Cystic accumulation of lymph or groin wound drainage occurring at an incision site if used for access. NOTE This test is not designed to evaluate the entire system; however, the system is required to deploy the stent that is under test. ISO Biological evaluation of medical devices — Part 1: All animals shall undergo post-mortem examination, including those that expire prior to scheduled termination. Appropriate testing shall be conducted as deemed necessary.
The test report shall include the following: The relevant design evaluation sections of this part of ISO? This test is required for stents that can experience direct compression in a clinical setting e. Haemostasis Balloon deflation time Balloon inflation time 8. It is recognized that not all of the tests described in this 2559-2 are applicable for each stent system design.
BS EN ISO 25539-2:2012
C ; i severity, management, outcome; ii documentation of stent system involvement i. Whether or not the failure contributed to an unsuccessful stent deployment should be documented. A rationale should be provided if a control device is not used in the study. NOTE Four tests are listed below, which determine forces related to the deformation of the stent.
If overlapping of stents can be anticipated in clinical use e. The test report for the preclinical in vitro testing should include an executive summary of all testing. These questions shall delineate the appropriate end points to be measured and include definitions of success and failure for each end point. All animals in the study shall be regularly examined.