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ISO 14708-4:2022

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems

standard by International Organization for Standardization , 03/01/2022

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Full Description

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.

 

Product Details

Published:
03/01/2022
File Size:
1 file , 3.1 MB
Same As:
BS EN ISO 14708-4:2022
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 14708-4:2022

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    Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems

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  2. ISO 14708-4:2008


    Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps

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