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prEN ISO 15798

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO/DIS 15798:2020)

General information
Draft
Base Documents
ISO/DIS 15798; prEN ISO 15798
Directives or regulations
None
Standard history
Status
Date
Type
Name
01.11.2017
Amendment
14.11.2013
Main
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.
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Standard monitoring