STN EN ISO 14708-4
| Name: | STN EN ISO 14708-4 |
| Validity: | Valid |
| Number of pages: | 72 |
| Language: |
EN
|
| Paper: | 28,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
25,92€ b) Without ability to print, with ability to copy (printscreen) 28,80€ c) With ability to print and copy (printscreen) 37,44€ |
| Slovak title | Chirurgické implantáty. Aktívne implantovateľné zdravotnícke pomôcky. Časť 4: Systémy implantovateľných infúznych púmp (ISO 14708-4: 2022) |
| English title | Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022) |
| Release Date: | 01. 10. 2022 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 3001 |
| Level of incorporation: | idt ISO 14708-4:2022, idt EN ISO 14708-4:2022 |
| Official Journal | 09/22 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |