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BSI BS EN ISO 16672:2021

Ophthalmic implants. Ocular endotamponades
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BSI BS EN ISO 16672:2021

Ophthalmic implants. Ocular endotamponades

PUBLISH DATE 2021
PAGES 24
BSI BS EN ISO 16672:2021

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.

SDO BSI: British Standards Institution
Document Number ISO 16672
Publication Date Oct. 14, 2021
Language en - English
Page Count 24
Revision Level
Supercedes
Committee CH/172/7
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