1 Scope
This part of YY 0290 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs).
It is applicable but not limited to non-toric, monofocal intraocular lenses intended for implantation into the anterior segment of the human eye.
Corneal implants are excluded.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY 0290. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of YY 0290 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 4315.1 Optical Transfer Function—Part 1:Terminology and Symbol
GB/T 4315.2 Optical Transfer Function—Part 2:Directives of Measurement
YY 0290.1 Ophthalmic Implants—Intraocular Lenses—Part 1: Terminology (YY 0290.1—2008, idt ISO 11979-1:2006)
3 Terms and Definitions
For the purposes of this part of YY 0290, the terms and definitions given in GB/T 4315.1 and YY 0290.1 apply.
4 Requirements
4.1 General
All requirements stated below shall apply to the finished product as marketed. If applicable, the IOLs shall be positioned as intended for use.
Note 1: The methods specified below are reference methods. Alternative methods demonstrated to produce results that are equivalent to those obtained with the reference methods may also be used.
Note 2: Any validated procedures that ensure that IOLs are within the tolerances specified may be used in quality control.
Foreword i
Introduction iii
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
Annex A (Normative) Measurement of Dioptric Power
Annex B (Normative) Measurement of Resolution Efficiency
Annex C (Normative) Measurement of Modulation Transfer Function (MTF)
Annex D (Informative) Precision of Dioptric Power Determination
Annex E (Informative) Precision of Imaging Quality Determination
Annex F (Informative) Verification of Ray Trace Calculations
Annex G (Informative) Selected Definitions
Annex H (Informative) Data on Blue Light Damage Function B(λ)
