60.60 Standard published Jun 26, 2020
ISO
ISO/TC 172/SC 7 Ophthalmic optics and instruments
International Standard
11.040.70 Ophthalmic equipment
Published
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WITHDRAWN
ISO 16672:2015
PUBLISHED
ISO 16672:2020
60.60
Standard published
Jun 26, 2020