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.
General information
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Status: PublishedPublication date: 2025-06Stage: International Standard published [60.60]
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Edition: 3Number of pages: 26
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Technical Committee :ISO/TC 172/SC 7ICS :11.040.70
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Life cycle
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Previously
WithdrawnISO 16671:2015
WithdrawnISO 16671:2015/Amd 1:2017
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Now
