CEN - EN ISO 16671
Ophthalmic implants - Irrigating solutions for ophthalmic surgery
Organization: | CEN |
Publication Date: | 1 August 2015 |
Status: | active |
Page Count: | 34 |
ICS Code (Ophthalmic equipment): | 11.040.70 |
scope:
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.