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EVS-EN ISO 16672:2021

Silmaimplantaadid. Okulaarsed endotamponaadid

Üldinfo
Kehtiv alates 01.11.2021
Alusdokumendid
ISO 16672:2020; EN ISO 16672:2021
Tegevusala (ICS grupid)
11.040.70 Silmaraviseadmed
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
01.11.2021
Põhitekst
06.10.2015
Põhitekst
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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