CIMEC 24726
CENTRO DE INVESTIGACION DE METODOS COMPUTACIONALES
Unidad Ejecutora - UE
informe técnico
Título:
Informe biocompatibilidad de IMVALV SP según ISO-10993
Autor/es:
FABIO A GUARNIERI
Fecha inicio/fin:
2019-04-10/2019-12-20
Naturaleza de la
Producción Tecnológica:
Biológica
Campo de Aplicación:
Tecnologia sanitaria y curativa-Varios
Descripción:
This document have been made using as a guidance the ?Use of International Standard ISO 10993-1, "Biological evaluationof medical devices- Part 1: Evaluationandtestingwithina risk management process? FDA document. The imValv System is a permanent implantable aqueous shunt to reduce intraocular pressure(IOP) in the anterior chamber of the eye. The System includes a pressure sensor to provide IOP measurement and monitoring hydraulic resistance. This measurement is used to guide treatment of Glaucoma.
