ISO 25539-4:2021

Тезис

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.

Общая информация

Текущий статус
: Published

Дата публикации
: 2021-11
Версия
: 1
Технический комитет
: ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
ICS
:
11.040.40 Implants for surgery, prosthetics and orthotics

Данный стандарт разработан для достижения следующих Цель устойчивого развития:

Хорошее здоровье и благополучие

Приобрести данный стандарт

	Формат	Язык
std 1 61	PDF + ePub
std 2 61	Бумажный

CHF61

Жизненный цикл

Сейчас

Published

ISO 25539-4:2021
Этап: 60.60

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