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prSRPS EN ISO 16672:2026

Ophthalmic implants — Ocular endotamponades

General information

10.99     Jul 25, 2026

ISS

Z172

European Norm

English  

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

PUBLISHED
SRPS EN ISO 16672 :2022

NOW

PROJECT
prSRPS EN ISO 16672:2026
10.99 New project approved
Jul 25, 2026

Related project

Adopted from prEN ISO 16672 rev IDENTICAL

Adopted from ISO/CD 16672 IDENTICAL