DIN EN ISO 16671:2015-12

The standard DIN EN ISO 16671 specifies fundamental requirements for ophthalmic irrigating solutions used in intraocular surgery. These irrigating solutions have no primary immunological, pharmacological or metabolic function. The requirements relate to the intended function of the product, the concentrations of the starting materials and the properties of the final product. In particular, requirements for the examination of biological safety, sterilization, stability of the product, packaging and information by the manufacturer are specified. The informative annexes give examples of a procedure for measuring pH and determining buffer capacity as well as for particle determination in the dark field or by microscopic methods. In addition, other annexes describe intraocular irrigation procedures and provide information on clinical trial. The responsible German standardization committee is Working Committee NA 027-01-20 AA "Intraokulare Medizinprodukte" ("Intraocular medical devices") at DIN Standards Committee Optics and Precision Mechanics (NAFuO).