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SRPS EN ISO 16672 :2022

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)

Feb 28, 2022

General information

60.60     Feb 28, 2022

ISS

Z172

European Norm

11.040.70  

English  

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Published

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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WITHDRAWN
SRPS EN ISO 16672:2016

NOW

PUBLISHED
SRPS EN ISO 16672 :2022
60.60 Standard published
Feb 28, 2022

Related project

Adopted from EN ISO 16672:2021

Adopted from ISO 16672:2020