Resumen
This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.
With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.
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Informaciones generales
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Estado: PublicadoFecha de publicación: 2020-06Etapa: Norma Internacional publicada [60.60]
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Edición: 3Número de páginas: 16
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Comité Técnico :ISO/TC 172/SC 7ICS :11.040.70
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Ciclo de vida
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Anteriormente
RetiradaISO 16672:2015
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Ahora
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