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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Biocompatibility should be tested in accordance with ISO? If alternative methods are employed, these methods should be justified. Haemostasis Balloon deflation time Balloon inflation time 8.

In general, all sizes and configurations shall be analysed unless it can be reasonably demonstrated that a worst-case exists. Other measurements might be needed to completely verify the dimensions of a particular stent. iao

BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents

Examination of the coating under appropriate magnification shall be conducted. Using a one-sided tolerance limit for a normal distribution: Whenever changes are made in materials, construction, configuration, application or processing methods, an appropriate analysis of the potential impact of the change on the failure modes and performance of the stent system shall be performed.

Stent integrity Conformability to vessel wall Corrosion? Significant reduction in luminal diameter at any point along the length of the stent when compared to the post-procedural reference diameter. Publication as an International Standard requires approval by at least 75? Isi were then identified to address each of ieo failure modes.

BS EN ISO 25539-2:2012

The sampling shall fully represent the range of device designs and might not necessarily require the testing of each size. Record the largest radius and location at which a kink or stent diameter reduction is observed. The stent sizes selected for testing should represent the worst case combination s of diameter and length for each test. Might be due to twisting or kinking of the stent, dissection, or any other cause.

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Evaluate the performance of the stent system using a model s that simulate s the intended use conditions. It might be necessary to conduct an analysis to identify the size s of the device with iiso greatest potential for failure.

Patency Force to deploy Local isso Determine the force to deploy the stent from the delivery system. Determine the appropriate dimensions of the stent coating for conformance with design specifications. In addition, for drug-eluting stents drug identity testing shall be performed, including the identification of impurities and degradants. The test report shall include the maximum, minimum, mean and standard deviation of all measured dimensions, isso results of any verified dimensions, and the results of the observations of the accessory compatibility.

Testing 25539-22 include the following items in 8. Each corrosion mechanism should be evaluated for specific stent designs, as appropriate. The material properties shall be selected as those appropriate to the specific stage of manufacturing and deployment being analysed.

The sampling should fully represent the range of device designs and might not necessarily require the testing of each size. For undated references, the latest edition of the referenced document including any amendments applies. A risk assessment shall be carried out and the requirements of ISO? All animals in the study shall be regularly examined. Further information is contained in tabular form in Annex?

The materials under evaluation shall undergo all manufacturing, fabrication and finish processing, as well as all post-processing steps such as cleaning. The stent size s and configurations to be tested 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. A rationale shall be provided for sample selection.

Individual test reports should include the following information: The packaging shall conform to ISO? The volume of blood lost during the procedure should be determined from the procedure report.

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Conformability of the deployed stent to the? Evaluate the ability of the stent system to advance through the vessel to the target site using the recommended accessories. This minor revision updates the normative references and provides minor editorial changes to Clause? The use of other technologies for visualization shall be justified. Determine the longitudinal bond strength between parts of the delivery system. It is impossible to take into consideration all future and emerging technologies.

Stent integrity Coating dimensions Coating durability 8. A statistical justification for the number of patients studied shall also be provided based upon the clinical hypotheses. The sizing scheme recommended for the stent in the IFU should take into consideration this recoil. Evaluate the ability of the stent system to provide sufficient rotation to the distal leading end to deliver the stent within the anatomy. The entire test should be completed rapidly to minimize the effects of viscoelastic behaviour and to better simulate the inflation method used clinically.

Sizing obtained with balloon inflation to the final outer diameter after balloon removal. The need for and the duration of dialysis, if required, should also be reported.

Ability to access Radial force Recoil 8.

ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

Reportable clinical events are defined in Annex? All bonds shall remain intact under recommended conditions of use. NOTE This test might also be of importance in evaluating the ability to withdraw. Whether or not the failure contributed to an unsuccessful stent deployment should be documented.