Borrador del Comité
ISO/CD 16672
Ophthalmic implants — Ocular endotamponades
Reference number
ISO/CD 16672
ISO/CD 16672
Edition 4
© ISO 2026
Borrador del Comité
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.
Informaciones generales
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Estado: En desarrolloEtapa: CD aprobado para su registro como DIS [30.99]
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Edición: 4
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Comité Técnico :ISO/TC 172/SC 7
- RSS actualizaciones
Ciclo de vida
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Anteriormente
PublicadoISO 16672:2020
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Ahora
