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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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. 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. The test report shall include the maximum, minimum, mean and standard deviation of all measured dimensions, the results of any verified dimensions, and the results of the observations of the accessory compatibility.
This outer container shall be designed so as to protect the unit container from damage due to storage.
BS EN ISO – Cardiovascular implants. Endovascular devices. Vascular stents
Note any anomalous findings e. Ability to deploy 8. Calculate the mean and standard deviation of the burst 2539-2. Note timing in relation to procedure. The results shall be evaluated in relation to the force s necessary to withdraw the system.
The test report shall also include the make and model of the imaging equipment, the parameter settings and details of the phantom tissue model.
ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Recurrent high blood pressure in the portal venous system. The record label should include the following information: All components shall be dimensionally compatible. Other measurements might be needed to completely verify the dimensions of a particular stent.
Sizing Dislodgment force Determine the force required to dislodge the stent from the original crimped position and to completely separate the stent from the nonexpanded balloon while simulating clinical use conditions.
For quantitative data, the maximum, minimum, mean and standard deviation shall be included. Guidance on corrosion assessment can be found from a variety of sources e. Consideration shall be given to the failure modes of the stent systems and their effects on the performance of the implant in identifying the appropriate testing.
Also record any anomalous observations e. 52539-2 at percutaneous or surgical access site requiring surgical debridement or vascular repair, and occurring within 30 days of the procedure. Testing beyond the scope of this part of ISO? Requirements for materials, sterile barrier systems and packaging systems?
A justification for the number of investigational sites shall be provided. Alternative methodology might need to be developed to appropriately evaluate this attribute for such devices.
Ability to withdraw 8. Testing to fracture shall be considered, but is not a requirement. Report the length of the stent segment under test. C informative Definitions of reportable clinical events Stent integrity Torquability 8.
BS EN ISO 25539-2:2012
The stent shall have satisfied appropriate preclinical testing requirements of this part of ISO? Care should oso taken not to damage the underlying substrate during conditioning. Report whether permanent deformation is observed and the radius at which permanent deformation is observed.
Patency Force to deploy Local compression Determine the force to deploy the stent from the delivery system. Io the type and purity of the drug and characterize the type and amount of degradants at manufacture and with storage. For example, fretting corrosion should be evaluated for stents that may be used in an overlapped condition.
The test report shall include the following: