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ISO 16672:2020

Ophthalmic implants — Ocular endotamponades
26 qer 2020

General information

90.60     3 sht 2025

ISO

ISO/TC 172/SC 7

International Standard

11.040.70  

anglisht   frëngjisht  

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 16672:2015

NOW

PUBLISHED
ISO 16672:2020
90.60 Close of review
3 sht 2025