ANSI Z80.30:2018 pdf download.Ophthalmics一Toric Intraocular Lenses.
This standard applies to any monotocal intraocular lens (IOL) whose primary indication is the reduction of astigmatism either with the correction of aphakia or the modification of the refractive power of a phakic eye. It does not include lOLs used to correct presbyopia.
This standard addresses the vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device. As applies to any standard, alternative validated test methods may be used.
2 Norn1atie references
The Ibliowing standards and regulations contain provisions that, through reterence 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 IE’ and ISO maintain registers of currently valid International Standards.
ANSI Z80.7, Ophthalmics — Intraocular lenses
ANSI Z80. 1 3, Ophihalmics Phakic intraocular lenses
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal we/fire requirements
ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local eflcts after implantatiomi
ISO 14 1 55—1, clinical investigalion of medical devices Part I: General requirements
ISO 1 4 1 5 5—2, clinical investigation of medical devices Part 2: Oinical invesfigaliomi plans
ISO 11 979— 1, Ophthalmic implants — intraocular lenses — Part 1: Vocabulary
ISO 11 979—2, Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
ISO 11 979—3, Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO 11 979—5, Ophthalmic implants — Intraocular lenses Part 5: Biocompatihility ISO 11 979-6, Ophthalmic implants — Intraocular lenses — Part 6. Shelf-life and transport stability
3 Definitions
For the purpose of this standard, the ftllowing definitions apply.
3.1 Toric IOL: Intraocular lens with at least one of the two surfaces (anterior or posterior) having a maximum and a minimum radii of curvature perpendicular to each other.
3.2 11eridian of Highest Dioptric Power: One of two orthogonal meridians with the most positive or least negative dioptric power.
3.3 Meridian of Lowest Dioptric Power: One of two orthogonal meridians with the least positive or most negative dioptric power.
3.4 Cylindrical Power: The difference in dioptric power between the meridians with the highest and lowest dioptric powers.
3.5 Cylindrical Axis: The axis of the meridian with the lowest dioptric power.
3.6 Spherical Equivalent: The average of the dioptric powers in the meridians with the highest and lowest dioptric power.
3.7 Phakic IOL: Intraocular lens whose primary indication is the modification of the refractive power of a phakic eye
4 Physical requirements
4.1 Scope
This clause applies to the physical properties of the tone IOL in its final form, as intended for implantation in the human eye.
4.2 Requirements
4.2.1 Tolerances and dimensions
The requirements given in 4.1 and 4.2 of ISO 1 1979-3 apply with the following additional requirements:
Tolerances specified apply to all labeled spherical equivalent and cylindrical powers.ANSI Z80.30 pdf download.