BS EN ISO 14708-4:2022
Current
The latest, up-to-date edition.
Implants for surgery. Active implantable medical devices. Implantable infusion pump systems
Hardcopy , PDF
English
03-08-2022
| Committee |
CH/150/2
|
| DocumentType |
Standard
|
| Pages |
70
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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 ISO14708-1:2014. The requirements of this document take priority over those of ISO14708-1. 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 Clause3. 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.
| Standards | Relationship |
| EN ISO 14708-4:2022 | Equivalent |
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