NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 11979-7 [CURRENT] references following documents:

Document number Edition Title
ISO 11979-1 2018-11 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary More 
ISO 11979-10 2018-03 Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes More 
ISO 14155 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice More 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
DIN EN ISO 11979-1 2019-05 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2018); German version EN ISO 11979-1:2018 More 
DIN EN ISO 11979-10 2018-08 Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018); German version EN ISO 11979-10:2018 More 
DIN EN ISO 14155 2021-05 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020 More 
DIN EN ISO 14971 2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More 
ISO/TR 22979 2017-05 Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications More