CSN EN ISO 16671

CSN EN ISO 16671 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.
Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.