Abstract

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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 

  • Status
     :  Published
    Publication date
     : 2020-06
  • Edition
     : 3
    Number of pages
     : 16
  • Technical Committee
     : ISO/TC 172/SC 7 Ophthalmic optics and instruments
  • ICS
     :
    11.040.70 Ophthalmic equipment

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals:

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure

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