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ISO 14708-4:2022

Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
28. 2. 2022.

Опште информације

60.60     28. 2. 2022.

ISO

ISO/TC 150/SC 6

Međunarodni standard

11.040.40  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 14708-4:2008

TRENUTNO

OBJAVLJEN
ISO 14708-4:2022
60.60 Standard objavljen
28. 2. 2022.

Nacionalna preuzimanja

SRPS EN ISO 14708-4:2022  
ISS

Implantati za hirurgiju – Aktivna implantabilna medicinska sredstva – Deo 4: Implantabilni sistemi infuzionih pumpi

60.60   Standard objavljen

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