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EVS-EN ISO 16672:2021

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)

General information
Valid from 01.11.2021
Base Documents
ISO 16672:2020; EN ISO 16672:2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
01.11.2021
Main
06.10.2015
Main
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 monitoring