60.60 Standard published Oct 13, 2021
CEN
CEN/TC 170 Ophthalmic optics
European Norm
11.040.70 Ophthalmic equipment
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.
WITHDRAWN
EN ISO 16672:2015
PUBLISHED
EN ISO 16672:2021
60.60
Standard published
Oct 13, 2021
IN_DEVELOPMENT
prEN ISO 16672 rev