Standard

NS-EN ISO 16672:2021

Nov 2021 Published

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Language English

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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.

Document information

Standard from SN
Published: 23 November 2021
Edition: 2021-10
Version: 1
Document type: NAT
ISBN:

ICS 11.040.70
National Committee CEN/TC 170

Product Relations

Replaces: NS-EN ISO 16672:2015
Adopted from: EN ISO 16672:2021 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 16672:2015
Current product

Published

NS-EN ISO 16672:2021

NS-EN ISO 16672:2021

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