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EN ISO 16671:2025

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2025) EN ISO 16671:2025

Publication date:   Aug 14, 2025

General information

60.60   Standard published   Jun 18, 2025

CEN

CEN/TC 170 Ophthalmic optics

European Norm

11.040.70   Ophthalmic equipment

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Scope

This document defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.
This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 16671:2015

WITHDRAWN
EN ISO 16671:2015/A1:2017

NOW

PUBLISHED
EN ISO 16671:2025
60.60 Standard published
Jun 18, 2025




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