ISO 14708-4:2022
Current
The latest, up-to-date edition.
Implants for surgery Active implantable medical devices Part 4: Implantable infusion pump systems
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
28-02-2022
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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.
| DocumentType |
Standard
|
| Pages |
58
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 14708-4:2022 | Identical |
| ÖVE/ÖNORM EN ISO 14708-4:2023 01 15 | Identical |
| DS/ISO 14708-4:2022 | Identical |
| SN EN ISO 14708-4:2022 | Identical |
| DS/EN ISO 14708-4:2022 | Identical |
| UNI EN ISO 14708-4 : 2022 | Identical |
| VDE 0750-20-4:2023-09 | Identical |
| DIN EN ISO 14708-4:2023-09 | Identical |
| UNE-EN ISO 14708-4:2023 | Identical |
| PN-EN ISO 14708-4:2023-01 | Identical |
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