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Released: 01.04.2022
CSN EN ISO 16672 - Ophthalmic implants - Ocular endotamponades

CSN EN ISO 16672

Ophthalmic implants - Ocular endotamponades

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English Hardcopy
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Number of Standard:CSN EN ISO 16672
Category:195302
Pages:28
Released:01.04.2022
Catalog number:513920
DESCRIPTION

CSN EN ISO 16672

CSN EN ISO 16672 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.
Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.