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ISO 15798:2013

Ophthalmic implants — Ophthalmic viscosurgical devices
2 sht 2013
95.99 Withdrawal of Standard   17 jan 2022

General information

95.99     17 jan 2022

ISO

ISO/TC 172/SC 7

International Standard

11.040.70  

anglisht   frëngjisht  

Buying

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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

WITHDRAWN
ISO 15798:2010

NOW

WITHDRAWN
ISO 15798:2013
95.99 Withdrawal of Standard
17 jan 2022

CORRIGENDA / AMENDMENTS

WITHDRAWN
ISO 15798:2013/Amd 1:2017

REVISED BY

PUBLISHED
ISO 15798:2022