ISO 25539-1 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements for terminology, design features, and information provided by the manufacturer based on available medical information. Guidance for the development of in vitro test methods is contained in the informative appendix to this standard. This standard can be considered a supplement to ISO 14630, which specifies general requirements for the performance of inactive surgical implants.
ISO 25539-1 is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels [e.g. creation of a transjugular intrahepatic portosystemic shunt (TIPS)].
Some of the requirements are specific to the endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than the treatment of arterial aneurysms or stenoses (eg, dissections, transections, shunts) are covered by this standard, special requirements and tests are not described. Similarly, certain prosthetic configurations (eg, windowed, branched) are covered, but specific requirements and tests for these devices are not disclosed.
ISO 25539-1 does not apply to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.
The valve component of valved channels formed with an endovascular prosthetic component and the combination of valved component and endovascular prosthesis component are beyond the scope of this document. The standard can assist in determining the appropriate evaluation of the endovascular prosthetic component of a valved duct, but specific requirements and tests for these devices are not described.
ISO 25539-1 does not address the requirements and evaluation of living tissues and non-living biological materials used in the construction of endovascular prostheses.
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