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
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Published (Edition 2, 2022)

ISO 14708-4:2022

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CHF 194
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2022-02
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 58
  • Technical Committee :
    ISO/TC 150/SC 6
    ICS :
    11.040.40 
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