ISO 25539-4:2021
Current
The latest, up-to-date edition.
Cardiovascular implants Endovascular devices Part 4: Application of ISO 17327-1 for coated endovascular devices
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
12-11-2021
This document specifies the appropriate application of ISO17327-1:2018 to coated endovascular prostheses, vascular stents, and vena cava filters. This document is intended to be used as a supplement to ISO25539-1, ISO25539-2, ISO25539-3, ISO12417-1 and ISO/TS17137.
The following coatings are within the scope of ISO17327-1 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 ISO17327-1, 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.
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.