ISO 16671:2002 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.
ISO 16671:2002 applies to ophthalmic irrigating solutions (OISs), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological or metabolic function.
Status: WithdrawnPublication date: 2003-05
Edition: 1Number of pages: 21
Technical Committee: ISO/TC 172/SC 7 Ophthalmic optics and instruments