NBN ISO 25539-4:2022

This document specifies the appropriate application of ISO 17327-1:2018 to coated endovascular
prostheses, vascular stents, and vena cava filters. This document is intended to be used as a supplement
to ISO 25539-1, ISO 25539-2, ISO 25539-3, ISO 12417-1 and ISO/TS 17137.
The following coatings are within the scope of ISO 17327-1 and addressed in this document for
endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-
absorbable), and chemistry-related surface modifications (oxide, such as TiO2
, and non-oxide, such as
amorphous silicon carbide and diamond-like carbon).
This document is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires),
as these coatings are not within the scope of ISO 17327-1, which is specifically directed to implant
coatings.
This document is not applicable to coverings of endovascular devices; however, if the covering of a
device is coated, it is within the scope of this document.
This document does not address the requirements for, and the evaluation of, viable tissues and non-
viable biologic materials used as implant coatings.