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prSSH EN ISO 16671:2025

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

General information

40.60     May 11, 2026

50.99   

DPS

DPS/KT 316

European Norm

11.040.70  

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

PUBLISHED
SSH EN ISO 16671:2015

PUBLISHED
SSH EN ISO 16671:2015/A1:2017

NOW

IN_DEVELOPMENT
prSSH EN ISO 16671:2025
40.60 Close of voting
May 11, 2026

Related project

Adopted from EN ISO 16671:2025 IDENTICAL

Adopted from ISO 16671:2025 IDENTICAL