BS EN ISO 16671:2015+A1:2017

This standard BS EN ISO 16671:2015+A1:2017 Ophthalmic implants. Irrigating solutions for ophthalmic surgery is classified in these ICS categories:

• 11.040.70 Ophthalmic equipment

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.