Standard

ISO 16672:2020

Jun 2020 Current

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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.

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Standard from ISO
Published: June 26 2020
Edition: 3
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.040.70
International TC: ISO/TC 172/SC 7

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Adopted by: NF EN ISO 16672:2021
Revises: ISO 16672:2015

ISO 16672:2020

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ISO 16672:2020

ISO 16672:2015

ISO 16672:2003

Abstract

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Version history History (3)

ISO 16672:2020

ISO 16672:2015

ISO 16672:2003

Abstract

Products specifications

Product Relations

Product life cycle