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 Bibliography includes a partial 25593-2 of references regarding corrosion terminology, equipment, test procedures and methods. Some requirements in the body of this part of ISO do not have associated test method guidance in this annex, as either the methodologies have not been standardized or are better addressed by other standards e.
A statistical justification for the number of patients studied shall also be provided based upon the clinical hypotheses. Might be due to twisting or kinking of the stent, intimal hyperplasia, dissection or any other cause.
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. The stent length to diameter relationship might be affected by angulation. As far as permitted by the limitations of the animal model, all devices used shall be of clinical quality and size, and of the design intended for clinical use.
Determine the amount of drug on the stent. Additional preconditioning steps might be appropriate for coated stents.
Development of a new atrial or ventricular arrhythmia or exacerbation of a prior arrhythmia isoo treatment i. Appropriate confidence and reliability parameters 25539- be used for determining RBP. Might be due to twisting or kinking of 255392 stent, failure of the stent to fully open, dissection or any other cause. NOTE Visibility is significantly affected by variations in equipment and parameter settings.
The plate deflection should be reduced by at least 50? Ability to withdraw 8. Determine the free or open surface area of the stent as a function of stent diameter and the contact area between the stent and the vessel. 25539–2 entire test should be completed rapidly to minimize the effects oso viscoelastic behaviour and to better simulate the inflation method used clinically.
In addition, the choice of animal model such as species, gender, age and whether or not isk lesion is created, shall be justified and shall be consistent with the study objectives. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Report the length of isi stent segment under test. Biocompatibility Assessment of haemostasis 8. The results shall be evaluated in relation to the force s necessary to withdraw the system.
Ability to deploy Bond strength 8.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
CH Geneva 20 Tel. For those tests with specified confidence and reliability parameters, the sample size shall have a statistical basis. Testing shall include the following items in 8. The results shall be evaluated in relation to the torque necessary to withdraw the system.
The length to diameter relationship should be reported in 25539–2 tabular format, including both absolute values and percentages. This summary should include identification of tests, with the rationale for the omission of any tests identified in Annex? Patient follow-up intervals shall include a minimum of a baseline assessment at discharge and at the end of the clinical evaluation. Ability to access Radial force Recoil 8. The record label should include the following information: Determine the RBP with an appropriate safety margin including reliability parameters of the balloon when used with the stent.
A rationale shall be provided for sample selection. The stent design might dictate the need to address functional requirements identified in both ISO?
While test methods have not yet been standardized, durability testing to fracture has several potential 25539–2, including identification of failure modes, verification of device fatigue analysis and appropriateness of factor of safety. Exceptions for the control population are noted below: The purpose of the test is to also determine whether the stent recovers its original geometry after testing.
BS EN ISO 25539-2:2012
Use of a compliant model should be considered. Testing shall include the following items listed in 8. The sampling shall fully represent the range of device designs and might not necessarily require the testing of each size.
These questions shall delineate the appropriate end points to be measured and include definitions of success and failure for each end point. MRI compatibility, pharmacokinetics for drug-eluting stents. The work of preparing International Standards is normally carried out through ISO technical committees.
C informative Definitions of reportable clinical events This annex contains examples of clinically reportable events and might not be all inclusive.
Myocardial infarction documented by the presence of raised cardiac enzymes within 30 days of the procedure. The specific syndrome or factor deficiency ies should also be noted. It is also recognized that additional methods might be combined when testing is conducted for a specific device.
For quantitative data, the maximum, minimum, mean and standard deviation shall be included. 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.