ISO 16672
Ophthalmic implants — Ocular endotamponades
active, Most Current
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| Organization: | ISO |
| Publication Date: | 1 June 2020 |
| Status: | active |
| Page Count: | 22 |
| ICS Code (Ophthalmic equipment): | 11.040.70 |
scope:
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.
Document History
ISO 16672
June 1, 2020
Ophthalmic implants — Ocular endotamponades
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...
August 1, 2015
Ophthalmic implants - Ocular endotamponades
This International Standard applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the...
February 1, 2003
Ophthalmic Implants - Ocular Endotamponades
A description is not available for this item.