ISO 25539-4:2021

Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices

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.

Edition	2021
Standard Part No	4
Published Date	2021
Published By	International Standardization Organisation
Page Count	11