Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems
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 ISOÂ 14708-1:2014. The requirements of this document take priority over those of ISOÂ 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.
NOTEÂ Â Â Â Â Â This document is not intended to apply to non-implantable infusion systems.
| SDO | ISO: International Organization for Standardization |
| Document Number | ISO 14708 |
| Publication Date | Not Available |
| Language | en - English |
| Page Count | |
| Revision Level | |
| Supercedes | |
| Committee | ISO/TC 150/SC 6 |
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