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CEN - EN ISO 16672

Ophthalmic implants - Ocular endotamponades

active, Most Current
Organization: CEN
Publication Date: 1 October 2021
Status: active
Page Count: 24
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

EN ISO 16672
October 1, 2021
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 European Standard is applicable to the construction and related testing of drains and sewers usually buried in the ground and usually operating under gravity but up to 0,5 kPa when surcharged....
February 1, 2003
Ophthalmic implants - Ocular endotamponades
A description is not available for this item.

References

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