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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.40 Implants for surgery, prosthetics and orthotics>BS EN ISO 14708-4:2022 Implants for surgery. Active implantable medical devices. Implantable infusion pump systems
immediate downloadReleased: 2022-08-03
BS EN ISO 14708-4:2022 Implants for surgery. Active implantable medical devices. Implantable infusion pump systems

BS EN ISO 14708-4:2022

Implants for surgery. Active implantable medical devices. Implantable infusion pump systems

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Standard number:BS EN ISO 14708-4:2022
Pages:70
Released:2022-08-03
ISBN:978 0 539 04468 3
Status:Standard
DESCRIPTION

BS EN ISO 14708-4:2022


This standard BS EN ISO 14708-4:2022 Implants for surgery. Active implantable medical devices. is classified in these ICS categories:
  • 11.040.40 Implants for surgery, prosthetics and orthotics
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.
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