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.
| File Size : | 1
file
, 1.8 MB |
| ISBN(s) : | 9780539044683 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 70 |
| Product Code(s) : | 30394029, 30394029, 2500729 |
| Published : | 08/03/2022 |
| Same As : | BS EN ISO 14708-4:2022 |
