ISO 14708:2022
ISO 14708:2022 Implants for surgery – Active implantable medical devices – Part 4: Implantable infusion pump systems
CDN $351.00
Description
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.
Edition
2
Published Date
2022-02-28
Status
PUBLISHED
Pages
58
Language
English
Format
Secure PDF
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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.
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