ISO 25539-2 PDF
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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Stent integrity Coating particulate generation 8. Any anomalies observed shall be reported. In general, all sizes and configurations shall 255392- analysed unless it can be reasonably demonstrated that a worst-case exists.
The requirements provided in this part of ISO? C informative Definitions of reportable clinical events This annex contains examples of clinically reportable events and might not be all inclusive.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
Vascular stent Implants cardiovasculaires? Significant reduction in luminal diameter at any point along the length of the stent when compared to the post-procedural reference diameter. In the selection of the equipment used for this evaluation, consideration should be given to this variability. Might be due to twisting or kinking of the stent, failure of the stent to fully open, dissection or any other cause.
Myocardial infarction documented by the presence of raised cardiac enzymes within 30 days of the procedure. For drugeluting stent studies, both bare metal and coated stents without the drugif applicable, should be used as control articles. Local, regional down-streamand systemic toxicities should be assessed. A that might be included in the information supplied by the manufacturer. Ability to access Radial force Recoil 8.
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The report shall sio a description of the anatomical model used, including the geometry and material of construction. Development of a new atrial or ventricular arrhythmia or exacerbation of a prior arrhythmia requiring treatment i.
Alternative methodology might need to be developed to appropriately evaluate this attribute for such devices. These 255392 mechanisms can include pitting, fretting, crevice and galvanic corrosion. Significant reduction in luminal diameter when compared to the post-procedural reference diameter. 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.
Stent integrity Torquability 8. 25539- length shall be defined as the length of the stent within the fixture. Record the largest radius and location at which a kink or stent diameter reduction is observed.
D informative Test methods Ability to access 8. CH Geneva 20 Tel. Radial pressure shall be expressed in kilopascals. The following stent types are within the scope of this part of ISO?
BS EN ISO 25539-2:2012
Examples include, but are not limited to, extremity, mesenteric and renal ischemia. NOTE 1 For permanently deformed stents e. Requirements for development, validation and routine control of a sterilization process for medical devices ISOPackaging for terminally sterilized medical devices — Part 1: C informative Definitions of reportable clinical events The need for blood transfusion and the volume and source banked, autologous, autotransfused of transfused blood should also be reported.
Infection at percutaneous or surgical access site requiring surgical debridement or vascular repair, and occurring within 30 days of the procedure. Stent fracture Fracture or breakage of any portion of the stent. The instructions shall include the following: The packaging shall conform to ISO?
Additional testing specific to certain materials e. Samples shall be subjected to conditions that are normally encountered which might affect the test results.