Reference number
ISO 25539-4:2021
International Standard
ISO 25539-4:2021
Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices
Edition 1
2021-11
Preview
ISO 25539-4:2021
77991
No disponible en español
Publicado (Edición 1, 2021)

ISO 25539-4:2021

ISO 25539-4:2021
77991
Idioma
Formato
CHF 63
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Resumen

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.

Informaciones generales

  •  : Publicado
     : 2021-11
    : Norma Internacional publicada [60.60]
  •  : 1
     : 11
  • ISO/TC 150/SC 2
    11.040.40 
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