Reference number
ISO 16672:2020
International Standard
ISO 16672:2020
Ophthalmic implants — Ocular endotamponades
Edition 3
2020-06
Read sample
ISO 16672:2020
70806
Published (Edition 3, 2020)

ISO 16672:2020

ISO 16672:2020
70806
Language
Format
CHF 96
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Abstract

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.

With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

General information

  •  : Published
     : 2020-06
    : International Standard published [60.60]
  •  : 3
     : 16
  • ISO/TC 172/SC 7
    11.040.70 
  • RSS updates

Life cycle

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