Standard

NEK EN ISO 14708-4:2022

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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.

Document information

  • Standard from NEK
  • Published:
  • Edition: 2022-07
  • Version: 1
  • Document type: NAT
  • ICS 11.040.40
  • National Committee CEN/CLC/JTC 16

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