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BSI BS EN ISO 15798:2022

Ophthalmic implants. Ophthalmic viscosurgical devices
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BSI BS EN ISO 15798:2022

Ophthalmic implants. Ophthalmic viscosurgical devices

PUBLISH DATE 2022
PAGES 32
BSI BS EN ISO 15798:2022
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.
SDO BSI: British Standards Institution
Document Number ISO 15798
Publication Date July 19, 2022
Language en - English
Page Count 32
Revision Level
Supercedes
Committee CH/172/7
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