DIN EN ISO 16671
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015 + Amd 1:2017) (includes Amendment :2017)
|Publication Date:||1 March 2018|
|ICS Code (Ophthalmic equipment):||11.040.70|
This International Standard 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 International Standard applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.