Alcance
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.
