Standard

SFS-EN ISO 14708-4:2022

Aug 2022 Published

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Language English

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Abstract

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.

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Standard from SFS-sähkö
Published: 5 August 2022
Edition: 1
Document type: IS
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Publisher SFS
Distributor SFS-sähkö
Technical Committee CEN/CLC/JTC 16

SFS-EN ISO 14708-4:2022

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