This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
ISO 11979-7:2018 Referenced Document
ISO 11979-10:2018 Ophthalmic implants - Intraocular lenses- Part 10:Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
ISO 11979-1:2012 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO/TR 22979:2017 Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications