ANSI Z80.35-2018 pdf download.Extended Depth of Focus Intraocular Lenses
1.Scope and purpose
This standard applies to intraocular lenses (IOLs) whose function is the correction of aphakia, with extended range of focus above a defined functional visual acuity threshold to provide useful distance and intermnediate vision with monotonically decreasing visual acuity from the best distance focal point. This standard addresses specific requirements for Extended Depth of Focus Intraocular Lenses (EDF IOLs) that are not addressed in the normative references, and include vocabulary, optical properties and test methods, mechanical propertics and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device, As with any standard, alternative validated test methods may be used.
2.Normative references
The following standards contain provisions that, through reference in this text, constitute provisions of this American National Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this American National Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of the IEC and ISO maintain registers of currently valid International Standards.
ANSI Z80.7, Ophthalmics – Intraocular lenses
ISO 10993-2. Biological evaluation of medical devices – Part 2: Animal welfare requirements
ISO 10993-6. Biological evaluation of medical devices – Part 6: Tests for local ffects afier implantation
ISO 11979-1, Ophthalmic implants一Intraocular lenses一Part 1: Vocabulary
ISO 11979-2. Ophthalmic implants – Intraocular lenses – Part 2: Optical properties and test methods
ISO 11979-3, Ophthalmic implans – Intraocular lenses一Part 3: Mechanical properies and test methods
ISO 11979-4, Ophthalmic implants一Intraocular lenses一Part 4: Labelling and information
ISO 11979-5. Ophthalmic implants – Intraocular lenses – Part 5: Biocomparibility
ISO 1979-7, Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations
ISO/DIS 11979-8, Ophthalmic implants一Intraocular lenses一Part 8: Fundamental requirements
ISO/WD 11979-9, Ophthalmic implants – Intraocular lenses – Part 9: Multifocal intraocular lensesANSI Z80.35-2018 pdf download
