Resumen
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.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2022-02Etapa: Norma Internacional publicada [60.60]
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Edición: 2Número de páginas: 58
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Comité Técnico :ISO/TC 150/SC 6ICS :11.040.40
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Ciclo de vida
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Anteriormente
RetiradaISO 14708-4:2008
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Ahora