Reference number
ISO 15798:2022
© ISO 2024
International Standard
ISO 15798:2022
Ophthalmic implants — Ophthalmic viscosurgical devices
Edition 4
2022-01
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Published (Edition 4, 2022)

ISO 15798:2022

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CHF 129
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Abstract

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.

General information

  • Status
     : Published
    Publication date
     : 2022-01
    Stage
    : International Standard published [60.60]
  • Edition
     : 4
    Number of pages
     : 19
  • Technical Committee :
    ISO/TC 172/SC 7
    ICS :
    11.040.70 
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