BS PD ISO/TR 22979:2017 Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ANSI/AAMI HE75-2009 Human factors engineering - Design of medical devices*， 2023-12-23 Update
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
ISO 11979-10:2006 Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses
ISO 11979-1:2012 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
ISO 11979-2:2014 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
ISO 11979-3:2012 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
ISO 11979-4:2008 Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information
ISO 11979-5:2006 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility
ISO 11979-6:2014 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
ISO 11979-7:2014 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations
ISO 11979-8:2017 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
ISO 11979-9:2006 Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14971:2007 Medical devices - Application of risk management to medical devices
BS PD ISO/TR 22979:2017 history
2017BS PD ISO/TR 22979:2017 Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications