ISO 15798:2022

Ophthalmic implants — Ophthalmic viscosurgical devices
Autor: ISO
Código ICS: 11.040.70
Vigente
$101.000

Alcance

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.

Especificaciones de la Norma
Fecha de Publicación 17/01/2022
Título Secundario Implants ophtalmiques — Dispositifs ophtalmiques viscoélastiques
Páginas Técnicas 19
Idioma Inglés