Standard

ISO 15798:2022

Jan 2022 Current

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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.

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Standard from ISO
Published: January 17 2022
Edition: 4
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.040.70
International TC: ISO/TC 172/SC 7

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Adopted by: NF EN ISO 15798:2022
Revises: ISO 15798:2013

ISO 15798:2022

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ISO 15798:2022

ISO 15798:2013

ISO 15798:2010

ISO 15798:2001

Abstract

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Version history History (4)

ISO 15798:2022

ISO 15798:2013

ISO 15798:2010

ISO 15798:2001

Abstract

Products specifications

Product Relations

Product life cycle