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ISO 15798:2022

Ophthalmic implants — Ophthalmic viscosurgical devices

Jan 17, 2022

General information

60.60     Jan 17, 2022

ISO

ISO/TC 172/SC 7

International Standard

11.040.70  

English   French  

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Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 15798:2013

WITHDRAWN
ISO 15798:2013/Amd 1:2017

NOW

PUBLISHED
ISO 15798:2022
60.60 Standard published
Jan 17, 2022

National adoptions

SRPS EN ISO 15798:2022  
ISS

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)

60.60   Standard published

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