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EN ISO 16672:2015

Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) EN ISO 16672:2015

Publication date:   Nov 16, 2015

General information

99.60 Withdrawal effective   Oct 13, 2021

CEN

CEN/TC 170 Ophthalmic optics

European Norm

11.040.70   Ophthalmic equipment

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Scope

ISO 16672:2015 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 retina.
With regard to the safety and efficacy of OE, this International Standard 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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 16672:2003

NOW

WITHDRAWN
EN ISO 16672:2015
99.60 Withdrawal effective
Oct 13, 2021

REVISED BY

PUBLISHED
EN ISO 16672:2021