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 stent shall have satisfied appropriate preclinical testing requirements of this part 255392- ISO? Whether or not successful stent deployment was achieved should be documented.
Requirements for materials, sterile barrier systems and packaging systems? Justification for the selection of tests shall be provided. It is recognized that not all tests identified in a? Evaluate MRI safety and compatibility. The sampling should fully represent the range of device designs and might not necessarily 2553-92 the testing of each size. 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.
Each corrosion mechanism should be evaluated for specific stent designs, as appropriate. This test is required for stents of a design with the potential for a different?
Ability to deploy Bond strength 8. The duration of ventilator support should be reported. Isso or not the failure contributed to an unsuccessful stent deployment should be documented. The testing shall be conducted at physiological temperature, unless otherwise justified.
All animals shall undergo post-mortem examination, including those that expire prior to scheduled termination. Evaluate the ability of the implant to maintain adequate contact with the vessel wall. Testing beyond the scope of this part of ISO? The investigation shall be carried out using ISO? Evaluate the ability of any seal or valves in the delivery system to maintain an adequate haemostatic seal when used with appropriate accessory devices.
Whether the deficit was permanent or transient should also be reported. In general, all sizes and configurations shall be analysed unless it can be reasonably demonstrated that a worst-case exists. Determine time required to deflate balloon and evaluate ability to remove deflated balloon. The imaging modality should be specified. All applicable steps of the deployment process will be evaluated.
BS EN ISO 25539-2:2012
A rationale should be provided for sample selection. If a tolerance is specified, the lesser value of the respective percentage shall be used. Local, regional down-stream 225539-2, and systemic toxicities should be assessed.
The packaging shall conform to ISO? Injury to adjacent structures associated with vascular trauma see definition below. Stent integrity Conformability to vessel wall Corrosion?
Results from the testing and 25539–2 analyses to evaluate the durability of the stent are complementary and should be interpreted both independently and in combination. A that might be included in the information supplied by the manufacturer. The criteria shall specify the target population i.
Determine the appropriate dimensions for conformance with design specifications. NOTE When selecting the test fixture, consideration should be given to the width or area under study, the effects of friction and the influence of the fixture geometry on the measured loads. Examples of delivery isso include balloon catheters or mechanically activated systems.
The type of treatment required should be reported. The volume of blood lost during the procedure should be determined from the procedure report. The stent system should be used for this test if the stent is intended to be mounted on the balloon during inflation. The degree of narrowing, the timing of the thrombosis in relation to the procedure, and imaging modality should be specified.
The information provided in each test report should be based upon a prospectively defined test protocol.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
The stent design might dictate the need to address functional requirements identified in both ISO and iao part of ISO? Determine the amount of drug that elutes ios the desired time period. Endovascular prostheses — Part? The sampling shall fully represent the range of device designs and might not necessarily require the testing of each size. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. C ; i severity, management, outcome; ii documentation of stent system involvement i.
The test report for the 2553-92 in vitro testing should include an executive summary of all testing. Haemodynamically significant thrombus formation within the lumen of the stent occurring at any time following stent placement. Injuries to vessels as a result of an endovascular procedure, including dissections or perforations, false or true aneurysms.
Ieo example, fretting corrosion should be evaluated for stents that may be used in an overlapped condition. Evaluate the long-term dimensional and structural integrity of the stent and any coating. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. Testing to fracture shall be considered, but is not a requirement. Determine the free or open surface area of the stent as a isl of stent diameter and the contact area between the stent and the vessel.
The use of other technologies for visualization shall be justified.