ČSN EN ISO 15798

Podrobné informácie

Označenie: ČSN EN ISO 15798

Dátum vydania: 01.09.2022

Stránok: 32

Krajina: Česká technická norma

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Anotácia

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