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EVS-EN ISO 15798:2013

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)

General information
Withdrawn from 01.03.2022
Base Documents
ISO 15798:2013; EN ISO 15798:2013
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.03.2022
Main
01.11.2017
Amendment
14.11.2013
Main
06.04.2010
Main
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants 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 intra-ocular tissues and to manipulate tissues during surgery. This International Standard 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.
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