ISO 16671:2025

Ophthalmic implants — Irrigating solutions for ophthalmic surgery Published (Edition 3, 2025)

Abstract

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.