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ISO 16672:2020

Ophthalmic implants - Ocular endotamponades
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ISO 16672:2020

Ophthalmic implants - Ocular endotamponades

ISO 16672:2020

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 ISO: International Organization for Standardization
Document Number ISO 16672
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 172/SC 7
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