BS ISO 25539-4:2021

Cardiovascular implants. Endovascular devices. Application of ISO 17327-1 for coated endovascular devices | Status: Current

1 Scope 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.