Ophthalmic implants. Ophthalmic viscosurgical devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

19-07-2022

Publisher

British Standards Institution

Committee	CH/172/7
DocumentType	Standard
Pages	32
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 15798:2013+A1:2017 BS EN ISO 15798:2013

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.