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BSI 21/30406209 DC:2021 Edition

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BS EN ISO 15798. Ophthalmic implants. Ophthalmic viscosurgical devices

Published By Publication Date Number of Pages
BSI 2021 25
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This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery.

This document specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

BSI 21/30406209 DC
$13.70