ISO 15798:2013

Ophthalmic implants — Ophthalmic viscosurgical devices

Publication date:   Sep 2, 2013

95.99 Withdrawal of Standard   Jan 17, 2022

General information

95.99 Withdrawal of Standard   Jan 17, 2022

ISO

ISO/TC 172/SC 7 Ophthalmic optics and instruments

International Standard

11.040.70   Ophthalmic equipment

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Scope

ISO 15798:2013 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.
ISO 15798:2013 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

Revises
ISO 15798:2010

NOW

WITHDRAWN
ISO 15798:2013
95.99 Withdrawal of Standard
Jan 17, 2022

CORRIGENDA / AMENDMENTS

Amended by
ISO 15798:2013/Amd 1:2017

REVISED BY

PUBLISHED
ISO 15798:2022