Published
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.
PUBLISHED
ISO 16671:2025
60.60
Standard published
Jun 12, 2025
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2025)
40.20 DIS ballot initiated: 12 weeks