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ISO 16672:2020

Ophthalmic implants -- Ocular endotamponades

General information
Valid from 26.06.2020
Directives or regulations
None
Standard history
Status
Date
Type
Name
26.06.2020
Main
07.08.2015
Main
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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