EN ISO 16672:2021

Oct 2021 Withdrawn

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Abstract

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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Standard from
Published: October 13 2021
Period for objection until: October 8 2018
Edition: 2
Document type: EN
Pages
ISBN:

Publisher: CEN
Distributor: CEN
ICS: 11.040.70
European TC: CEN/TC 170

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Abstract

Products specifications