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ČSN EN ISO 14708-4 (853010)
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems
Translate name
STANDARD published on 1.1.2023
The information about the standard:
Designation standards: ČSN EN ISO 14708-4
Classification mark: 853010
Catalog number: 515974
Publication date standards: 1.1.2023
SKU: NS-1097971
The number of pages: 76
Approximate weight : 228 g (0.50 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 14708-4 (853010):
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
