What is ISO 25539-2 about?
ISO 25539 discusses endovascular devices for cardiovascular implants. ISO 25539-2 outlines requirements for the evaluation of stent systems (vascular stents and delivery systems). ISO 25539-2 specifies requirements with respect to nomenclature, design attributes, and information supplied by the manufacturer, based upon current medical knowledge.
ISO 25539-2 applies to vascular stents and vascular scaffolds (e.g., absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies.
Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents are within the scope of ISO 25539-2. Vascular stents that have surface modifications, such as drugs and/or other coatings, are within the scope of ISO 25539-2.
Balloons integral to the stent system are within the scope of this document. ISO 25539-2 provides requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with vascular stents.
Note 1: ISO 25539-2 does not apply to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices.
Note 2: Although drug-eluting stents are within the scope of ISO 25539-2 and are not comprehensive with respect to the drug-eluting properties of these devices.
Note 3: Vascular device-drug combination products are within the scope of ISO 12417-1.
Note 4: Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of ISO 25539-2 will be necessary.
Who is ISO 25539-2 for?
ISO 25539-2 on endovascular devices for cardiovascular implants is useful for:
- Manufacturers of cardiovascular implants
- Test centres for endovascular devices
- Regulatory authorities
Why should you use ISO 25539-2?
Endovascular devices are primarily used to treat infrarenal abdominal aortic aneurysms with or without associated iliac artery aneurysms.
ISO 25539-2 guideline provides general requirements for stents systems, intended performance, design attributes, materials, design evaluation, post-market surveillance, sterilization, and packaging for endovascular devices.
This improves the quality and functionality of endovascular devices
