International Standard
ISO 15798:2022
Ophthalmic implants — Ophthalmic viscosurgical devices
Reference number
ISO 15798:2022
Edición 4
2022-01
International Standard
Vista previa
ISO 15798:2022
79687
No disponible en español
Publicado (Edición 4, 2022)

ISO 15798:2022

ISO 15798:2022
79687
Idioma
Formato
CHF 129
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Resumen

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.

Informaciones generales

  •  : Publicado
     : 2022-01
    : Norma Internacional publicada [60.60]
  •  : 4
     : 19
  • ISO/TC 172/SC 7
    11.040.70 
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