DPS
Drejtoria e Përgjithshme e Standardizimit
0 Items
My account
E-albania
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

SSH EN ISO 16672:2021

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)

Aug 29, 2022

General information

60.60     Aug 29, 2022

DPS

DPS/KT 316

European Norm

11.040.70  

English  

Buying

Published

Language in which you want to receive the document.

Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 16672:2015

NOW

PUBLISHED
SSH EN ISO 16672:2021
60.60 Standard published
Aug 29, 2022

Related project

Adopted from EN ISO 16672:2021