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ISO 14708-4:2022

Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems

Standard Details

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
Standard Type: Main
Document No: ISO 14708-4:2022
Document Year: 2022
Pages: 58
Edition: 2
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

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ISO 14708-4:2022
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