Reference number
ISO 14708-4:2022
© ISO 2024
International Standard
ISO 14708-4:2022
Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
Edition 2
2022-02
Preview
недоступно на русском языке
Опубликовано (Версия 2, 2022)

ISO 14708-4:2022

Язык
Формат
CHF 194
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Тезис

This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1.

This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.

This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3.

The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products.

NOTE       This document is not intended to apply to non-implantable infusion systems.

Общая информация

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2022-02
    Этап
    : Опубликование международного стандарта [60.60]
  • Версия
     : 2
  • Технический комитет :
    ISO/TC 150/SC 6
    ICS :
    11.040.40 
  • RSS обновления

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