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SSH EN ISO 16672:2015

Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)

Mar 29, 2016
95.99 Withdrawal of Standard   Aug 29, 2022

General information

95.99     Aug 29, 2022

DPS

DPS/KT 316

European Norm

11.040.70  

English  

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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 directives

Directives related to this standards.

93/42/EEC

Medical devices

Directive 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 16672:2005

NOW

WITHDRAWN
SSH EN ISO 16672:2015
95.99 Withdrawal of Standard
Aug 29, 2022

REVISED BY

PUBLISHED
SSH EN ISO 16672:2021

Related project

Adopted from EN ISO 16672:2015