Standard No.:	YY 0290.2-2009
English Name:	Ophthalmic implants—Intraocular lenses—Part 2:Optical properties and test methods
Chinese Name:	眼科光学 人工晶状体 第2部分：光学性能及试验方法
Chinese Classification:	C40    Medical optical instrument and endoscope
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.70 11.040.70    Ophthalmic equipment 11.040.70
Source Content Issued by:	China Food and Drug Administration
Issued on:	2009-06-16
Implemented on:	2009-12-1
Status:	superseded
Superseded by:	YY 0290.2-2021 Ophthalmic optics-Intraocular lenses- Part 2:Optical properties and test methods
Superseded on:	2023-4-1
Superseding:	YY 0290.2-1997 Intraocular lenses―Part 2:Optical properties and their test methods
Target Language:	English
File Format:	PDF
Word Count:	12000 words
Translation Price(USD):	300.0
Delivery:	via email in 1 business day

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)