Standard

NS-EN ISO 15798:2022

Feb 2022 Published

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Abstract

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.

Document information

Standard from SN
Published: 15 February 2022
Edition: 2022-02
Version: 1
Document type: NAT
ISBN:

ICS 11.040.70
National Committee CEN/TC 170

Product Relations

Replaces: NS-EN ISO 15798:2013
Adopted from: EN ISO 15798:2022 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 15798:2013

Withdrawn

NS-EN ISO 15798:2013/A1:2017
Current product

Published

NS-EN ISO 15798:2022

NS-EN ISO 15798:2022

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