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YY 0290.2-2021 English PDF (YY 0290.2-2009, YY 0290.2-1997)

YY 0290.2-2021_English: PDF (YY0290.2-2021)
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YY 0290.2-2021English410 Add to Cart 0--9 seconds. Auto-delivery Ophthalmic optics -- Intraocular lenses -- Part 2: Optical properties and test methods Valid YY 0290.2-2021
YY 0290.2-2009English305 Add to Cart 0--9 seconds. Auto-delivery Ophthalmic implants. Intraocular lenses. Part 2: Optical properties and test methods Obsolete YY 0290.2-2009
YY 0290.2-1997English519 Add to Cart 4 days [Need to translate] Intraocular lenses. Part 2: Optical properties and their test methods Obsolete YY 0290.2-1997


BASIC DATA
Standard ID YY 0290.2-2021 (YY0290.2-2021)
Description (Translated English) Ophthalmic optics -- Intraocular lenses -- Part 2: Optical properties and test methods
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C40
Classification of International Standard 11.040
Word Count Estimation 27,247
Date of Issue 2021-03-09
Date of Implementation 2023-04-01
Older Standard (superseded by this standard) YY 0290.2-2009
Drafting Organization Zhejiang Medical Equipment Inspection and Research Institute, Ningbo Dawei Medical Equipment Co., Ltd.
Administrative Organization National Medical Optics and Instrument Standardization Sub-Technical Committee (SAC/TC 103/SC 1)
Regulation (derived from) State Drug Administration Announcement No. 37 of 2021
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

BASIC DATA
Standard ID YY 0290.2-2009 (YY0290.2-2009)
Description (Translated English) Ophthalmic implants. Intraocular lenses. Part 2: Optical properties and test methods
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C40
Classification of International Standard 11.040.70
Word Count Estimation 23,276
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Older Standard (superseded by this standard) YY 0290.2-1997
Quoted Standard GB/T 4315.1; GB/T 4315.2; YY 0290.1
Adopted Standard ISO 11979-2-1999, MOD
Drafting Organization Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Administrative Organization National Standardization Technical Committee of Medical optics and instruments
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Proposing organization National Standard Committee on Medical Optics Standardization (SAC/TC 103/SC 1)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the primary IOL optical performance requirements and test methods. This standard applies to non-implanted in the anterior segment of the ring surface monofocal intraocular lens. This standard does not include corneal implants.

BASIC DATA
Standard ID YY 0290.2-1997 (YY0290.2-1997)
Description (Translated English) Intraocular lenses. Part 2: Optical properties and their test methods
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C45
Word Count Estimation 13,114
Date of Issue 1997/5/27
Date of Implementation 1997/7/1
Adopted Standard ISO/CD 11979-2-1995, NEQ
Drafting Organization State Administration of Medicine medical optics, laser, cold therapy equipment quality testing center
Administrative Organization National Medical Optical and Instrument Standardization Subcommittee
Regulation (derived from) State-Food-Drug-Supervision-Device (2005) 126; Industry Standard Filing Notice 2009 No. 9
Proposing organization State Administration of Medicine
Issuing agency(ies) State Administration of Medicine


YY 0290.2-2021 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040 C 40 Replacing YY 0290.2-2009 Ophthalmic optics - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014, MOD) ISSUED ON: MARCH 09, 2021 IMPLEMENTED ON: APRIL 01, 2023 Issued by: National Medical Products Administration Table of Contents Foreword ... 3 Introduction ... 6 1 Scope ... 7 2 Normative references ... 7 3 Terms and definitions ... 7 4 Requirements ... 8 Appendix A (Normative) Measurement of optical power ... 14 Appendix B (Normative) Measurement of resolution ... 24 Appendix C (Normative) Measurement of MTF ... 27 Appendix D (Informative) Precision of optical power measurements ... 34 Appendix E (Informative) Precision of image quality measurement ... 35 Appendix F (Informative) Verification of ray tracing calculations ... 36 References ... 37 Ophthalmic optics - Intraocular lenses - Part 2: Optical properties and test methods 1 Scope This Part specifies the main optical performance requirements and test methods of intraocular lenses (IOLs). This Part applies to spherical, aspheric, monofocal, toric, multifocal and/or accommodating intraocular lenses, which are implanted in the anterior segment of the human eye. The generic character "intraocular lens (IOLs)" used in this Part also includes phakic intraocular lens (PIOL). 2 Normative references The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this standard. GB/T 4315.1 Optical transfer function - Part 1: Terminology and symbol (GB/T 4315.1-2009, ISO 9334:2007, MOD) GB/T 4315.2 Optical transfer function - Part 2: Directives of measurement (GB/T 4315.2-2009, ISO 9335:1995, MOD) GB/T 9045-2006 Photography - Photographic materials - Determination of ISO resolving power (ISO 6328:2000, IDT) YY 0290.1 Ophthalmic implants - Intraocular lenses - Part 1: Terminology (YY 0290.1-2008, ISO 11979-1:2006, MOD) YY 0290.3 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (YY 0290.3-2018, ISO 11979-3:2012, MOD) YY 0290.4 Ophthalmic implants - Intraocular lenses - Part 4: Labeling and information (YY 0290.4-2008, ISO 11979-4:2000, IDT) 3 Terms and definitions The terms and definitions, which are defined in YY 0290.1 and GB/T 4315.1, apply to 4.3.1 Overview Image quality depends on the match between the optical design of the IOL and the optical performance evaluation conditions. Image quality can be expressed by resolution or modulation transfer function (MTF) value, under specified spatial frequency conditions. Perform the resolution test, according to the method specified in Appendix B. Perform the modulation transfer function (MTF) test, according to the method specified in Appendix C. The modulation transfer function (MTF), which is determined by the method described in Appendix C, is related to the matching -- between the optical design and the model eye suitable for optical performance evaluation. For the method described in Appendix C, example model eye parameters have been given. The manufacturer may also propose an equivalent method or model eye suitable for the intended use and design optical properties. In such cases, the model eye and method shall be adequately described, along with justification for its applicability. Unless otherwise specified, image quality requirements apply to all available optical powers. If, due to theoretical limitations, negative and low power intraocular lenses, which has the simulated eye described in Appendix C, do not apply to the requirements specified in 4.3.2 ~ 4.3.6, the manufacturer shall verify the applicable spatial frequency and requirements. If the image quality of a specially designed intraocular lens for a special purpose is not applicable to the requirements specified in 4.3.2 ~ 4.3.6, the manufacturer shall set and verify the applicable spatial frequency and requirements. Note 1: The optical resolution is expressed in terms of spatial frequency. The unit is usually line logarithm/mm (lp/mm) or cycle/mm (c/mm or mm-1). In ophthalmology literature, the commonly used unit is cycle/degree (c/degree). For the eyes, the image square node distance is considered to be 17 mm; the conversion formula between the two is as follows: c/degree = 0.297 × c/mm Note 2: The test aperture, which is provided in 4.3 and Appendix A, Appendix B, Appendix C, indicates the central area of the test intraocular lens exposure, which is different from the aperture stop of the test system. 4.3.2 Monofocal intraocular lenses 4.3.2.1 Overview The image quality of monofocal intraocular lenses shall meet any of the requirements specified in 4.3.2.2, 4.3.2.3 or 4.3.2.4. 4.3.2.2 Resolution If tested according to the method in Appendix B, the resolution of the intraocular lens shall not be less than 60% of the diffraction-limited cut-off spatial frequency, under the 3 mm aperture. In addition, the image shall be free of detectable aberrations other than spherical aberration. 4.3.2.3 MTF measurement using model eye 1 If tested according to the method of model eye system 1 (C.3.1) in Appendix C, the modulation transfer function (MTF) value of the intraocular lens, in the model eye system, shall meet one of the following two conditions, at a spatial frequency of 100 mm-1: a) Greater than or equal to 0.43; b) Greater than or equal to 70% of the calculated maximum attainable value, which is given by the design and analysis of the intraocular lens in the model eye system; however in any case, it shall not be less than 0.28. Note: For PMMA intraocular lenses within the range of 10D ~ 30D, the evaluation criteria given in 4.3.2.2 and 4.3.2.3a) have good consistency. 4.3.2.4 MTF measurement using model eye 2 If tested according to the method of model eye system 2 (C.3.2) in Appendix C, the modulation transfer function (MTF) value of the intraocular lens, in the model eye system, shall meet the requirement that the intraocular lens, under the aperture of greater than or equal to 3 mm, at the spatial frequency of 100 mm-1, reaches 70% of the calculated maximum achievable value given in the design and analysis of model eye system; however, in any case, it shall not be less than 0.28. 4.3.3 Toric intraocular lens (TIOL) 4.3.3.1 Overview The image quality of the toric intraocular lens shall meet the requirements, which are specified in 4.3.3.2 or 4.3.3.3. 4.3.3.2 Resolution When using the compensating lens method in Appendix B, the resolution requirements specified in 4.3.2.2 shall apply to the combined system of toric intraocular lens and compensating lens. 4.3.3.3 MTF The MTF requirements, which are specified in 4.3.2.3 or 4.3.2.4, shall apply to the meridian of highest and lowest optical power. Use a spectrophotometer, to measure and record the spectral transmittance of the intraocular lens in the test solution, in the range of 300 nm ~ 1100 nm with an aperture of 3 mm. If it is measured in air, it can be corrected, according to the principle of specular reflection. The transmittance accuracy shall be better than ±2%; the resolution shall not be less than 5 nm. The sample shall be an actual IOL or an alternative plate of IOL optical material, the thickness of which shall be equal to the central thickness of a 20D IOL; meanwhile, it shall be subjected to the same manufacturing process as the finished IOL, including sterilization. Note 1: The aqueous humor can be replaced by saline solution, which contains 0.9% NaCl during the test. Note 2: If the spectral transmittance of the intraocular lens material changes with the temperature in the solution, the spectral transmittance shall be measured, at a simulated intraocular temperature. Note 3: If the thickness of the test solution, in the measurement optical path, is changed due to the insertion of the intraocular lens or the plate into the test solution during the test, then the influence of the change in the spectral transmittance on the test results shall be analyzed and corrected, if necessary. A feasible correction method is to measure the transmittance, within the spectrum of the replaced equivalent thickness of the test liquid, as a correction factor. 4.4.2 Spectral transmittance record The manufacturer shall give a record of the spectral transmittance of the intraocular lens or equivalent with a focal power of 20D, within the wavelength range of 300 nm ~ 1100 nm (for example: recorded in the instruction manual or on the packaging). Under the same test conditions, the measured value in the spectral range of 380 nm ~ 1100 nm shall be consistent with the record, which is given by the manufacturer. The spectral transmittance shall drop by 5%, in the range above the wavelength corresponding to the inflection point; the spectral transmittance deviation shall not be greater than ±5%. 4.4.3 Cut-off wavelength Spectral transmittance records shall show that the IOL is filtered out in the ultraviolet (UV) portion of the spectrum. For an intraocular lens, which has a focal power of 20D or equivalent, when the wavelength corresponding to the spectral transmittance of 10% is used as the UV cut-off wavelength, the wavelength shall not be less than 360 nm. Appendix A (Normative) Measurement of optical power A.1 Overview This Appendix gives a variety of methods for the determination of optical power. These methods are applicable to spherical and aspheric monofocal, toric or multifocal IOLs. The power values of all intraocular lenses are defined in the intraocular state (refer to YY 0290.1). The peak wavelength of the light source is 546 nm ± 10 nm; the full width at half maximum is 20 nm or less. For the measurement methods A.3 and A.4, the diameter of the aperture stop is 3.0 mm ± 0.1 mm. Note 1: For the detailed description of the measurement and calculation of optical power, please refer to relevant optical books. Note 2: It may be necessary to modify the measurement device (such as an additional convex lens, select a microscope objective with an appropriate numerical aperture, etc.), to measure the focal length of negative power and low power intraocular lenses. A.2 Calculation of optical power by measuring dimensions A.2.1 Steps The radius of curvature, which has a diameter of about 3 mm, can be measured by a dedicated spherometer, interferometer or optical coherence tomography (OCT). Lens thickness can be measured by a micrometer or similar device. The calculation of optical power adopts formula (A.1): Simulate the state conditions in the eye, where: F - Intraocular lens power, in diopters (D); Ff - The optical power of the front surface of the intraocular lens, in diopters (D); Fb - The optical power of the posterior surface of the intraocular lens, in diopters (D); tc - The central thickness of intraocular lens, in meters (m); nIOL - The refractive index of the intraocular lens optical material in the intraocular Due to the complexity of the optical design of multifocal IOLs and astigmatic IOLs, this method is limited to monofocal IOLs. A.3 Calculation of optical power by measuring back focal length or effective focal length A.3.1 Principle The method described in A.3 assumes that measurements are made in air. However, with appropriate adjustments, this method is also suitable for measurements in simulated intraocular conditions. Back vertex focal length (BFL) refers to the distance -- from the posterior vertex of the intraocular lens to the on-axis focal point. This method has previously been used for measurements on monofocal crystals in air. Effective focal length (EFL) refers to the distance -- from the second principal plane of the intraocular lens to the on-axis focal point. The effective focal length (EFL) is measured, through the nodal slide rail. Both methods are suitable for intraocular lens, multifocal intraocular lens, toric intraocular lens measurements, when the following adjustments are made. Note 1: The focus position depends on the spatial frequency used for focusing. If there is spherical aberration, the measured lens focus position does not match the paraxial focus position. Measuring focus is often referred to as "best focus". Note 2: BFL, EFL and correction are all vectors. The positive direction is the direction, in which the optical axis faces the image. A.3.2 Equipment The optical bench, as shown in Figure A.1, has the following characteristics: a) The collimating achromatic lens with basically no aberration is used in conjunction with the light source; the focal length of the collimating lens should be more than 10 times the focal length of the intraocular lens to be tested; b) On the focal plane of the collimating lens, diffuse light from the light source illuminates a spatial frequency reticle, such as the U.S. Air Force 1951 resolution version (see Figure B.1); c) The maximum distance -- from the aperture stop (3.0 mm ± 0.1 mm) to the front of the tested intraocular lens -- is 3 mm; d) The surrounding medium is air; e) The numerical aperture of the microscope objective lens shall be larger than the spatial frequency. Calculation of the effective focal length EFL, f of the intraocular lens can be carried out, by formula (A.11): Add spherical aberration correction value (see A.5) to f, to obtain the paraxial focal length, fair. Further calculate the optical power in air and solution, according to the formula (A.8), formula (A.9), formula (A.10). A.4.4 Applicability The method described above is applicable to rotationally symmetric spherical or aspheric IOLs. A.4.5 Precision For monofocal intraocular lenses, the repeatability and reproducibility are the precision characteristics of optical power, which should be 0.5% and 1%, respectively. A.5 Determination of optical power and axial error of toric intraocular lens A.5.1 Overview The method, which is described in A.2 and A.3, can be modified to measure the optical power on the main meridian of the highest and lowest optical power, AND to allow the measurement axis to be aligned with the axis mark of the lowest optical power meridian. A.5.2 Without compensating lens For toric IOLs, the optical powers of the two principal meridians are determined as follows: a) According to A.2: Calculate the optical power by measuring the dimensions (including the radius of curvature) of the two principal meridians. b) According to A.3: Calculate the optical power, by measuring the back vertex focal length of the two principal meridians. The measured principal meridian is aligned with the applicable target, by obtaining a sharp and clear image. c) According to A.4: Calculate the optical power, by measuring the magnification of the two principal meridians. The measured principal meridian is aligned with the applicable target, by obtaining a sharp and clear image. The calculation method of spherical equivalent focal power (SE) is as follows: SE = (Power of high power meridian + power of low power meridian)/2 Cylinder lens power (CYL) is calculated as follows: CYL = Power of high power meridian - power of low power meridian Note: This method is suitable for cylindrical lens focal power below 5D. A.5.3 Using compensating lenses The optical bench described in A.3.2 can be modified, to add a positive cylindrical lens (compensation lens), which is installed behind or in front of the toric intraocular lens to be tested, for determining the equivalent spherical lens power (SE) and cylindrical lens power (CYL). Compensating lenses are capable of compensating for the cylindrical lens of a toric intraocular lens (TIOL). The cylindrical axis of the compensating lens shall be aligned with the principal meridian of the toric intraocular lens (TIOL) meridian of highest power. The focal power and position of the compensating lens are selected, to ensure that the optical combination of the compensation lens and the intraocular lens can obtain a clear image of the two-dimensional target. Use the method described in A.3 or A.4, to measure the uncorrected power of the main meridian of the highest power; then measure the position of the compensating lens. According to the focal power of the compensating lens and the position of the main plane of the meridian relative to the lowest focal power of the toric intraocular lens, the cylinder power of the intraocular lens can be calculated, by using a combination formula. A.5.4 Determination of axis position error A.5.4.1 Without compensating lens Use A.5.2b) or A.5.2c) method, to determine the axial error. When a best-focus image is obtained, calculate the angle -- between the target principal direction and the axial marker. This angle is the axis position error. A.5.4.2 Using compensating lenses Use the method in A.5.3, to determine the axis position error. When the best focused image is obtained, calculate the angle -- between the cylindrical axis of the compensation lens or its orthogonal meridian and the axial mark of the toric IOL, the smaller of which is the axial error. Note: Orthogonality errors -- between the lowest and highest focus meridians -- are evident in image quality measurements. A.6 Power determination for multifocal intraocular lenses (MIOL) Two methods of determining optical power apply to multifocal intraocular lenses (A.3 and A.4). The measurement of optical power shall be carried out under the aperture of Appendix B (Normative) Measurement of resolution B.1 Overview This Appendix presents principles, devices, and methods applicable to the measurement of intraocular lens resolution. B.2 Principle The resolution limit of an intraocular lens, expressed as a percentage compared to the diffraction-limited cutoff spatial frequency of an ideal lens with the same focal length, has equivalent aperture stop, wavelength, media environment. The aperture is 3.0 mm, the surrounding medium is air, the peak wavelength of the light source is 546 nm (±10 nm); its full width at half maximum is 20 nm or less. B.3 Equipment Optical bench as shown in Figure A.1. Note: The image quality measurement of negative power and low power intraocular lenses may require a modified workbench (such as additional convex lens, microscope objective lens with appropriate numerical aperture, etc.) for quantification. B.4 Steps Place the intraocular lens in the optical bench; position its center on the optical axis as much as possible. Focus the image on the resolution plate, by moving the objective lens of the microscope, to obtain an image that is as comprehensive and balanced as possible with thick and thin line patterns (see Figure B.1). Determine the thinnest pattern (group, unit), in which horizontal and vertical lines can be resolved at the same time. In addition, all thick lines shall be resolved. See 5.3.5.1 of GB/T 9045-2006, for judgment criteria of resolution. B.5 Calculation B.5.1 For the spatial frequency ν, expressed in the reciprocal of millimeter (mm-1), the finest discernible pattern is calculated from formula (B.1): Appendix C (Normative) Measurement of MTF C.1 Overview This Appendix presents the principles, equipment, methods, which are applicable to the measurement of the modulation transfer function of rotationally symmetric monofocal intraocular lenses. For other types of IOLs, the required modifications are given at the end of this Appendix. C.2 Principle The intraocular lens is placed in the model eye; the modulation transfer function (MTF) is measured using monochromatic light. The peak wavelength of the light source is 546 nm (±10 nm); its full width at half maximum is 20 nm or less. The model eye, which is described in this Appendix, is a tool for establishing quality criteria for intraocular lenses. It is used to formulate the limits in 4.3, not as a reference for actual human eye performance. C.3 Equipment C.3.1 Model eye 1 Model eye 1 has the following properties: a) The simulated cornea is a lens, which has minimal aberrations, as described in Table C.1; b) The front surface of the intraocular lens is placed on a plane, which is 26 mm ~ 28 mm in front of the focal point of the simulated cornea; the refractive index of the imaging medium is 1.336; c) The converging beam from the simulated cornea is irradiated on the central circular area of the intraocular lens; the applicable test diameter tolerance is ±0.1 mm; d) The intraocular lens is placed in a liquid medium -- between two planar windows; e) The difference -- between the refractive index of the intraocular lens and the liquid medium and the condition in the eye -- shall be within 0.005; f) The image plane falls in the air, which is outside the last window of the model eye. ......


YY 0290.2-2009 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.70 C 40 Replacing YY 0290.2-1997 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:1999, MOD) ISSUED ON: JUNE 16, 2009 IMPLEMENTED ON: DECEMBER 01, 2010 Issued by: China Food and Drug Administration Table of Contents Foreword ... 3 Introduction ... 5 1 Scope ... 6 2 Normative references ... 6 3 Terms and definitions ... 6 4 Requirements ... 6 Annex A (normative) Measurement of dioptric power ... 11 Annex B (normative) Measurement of resolution efficiency ... 18 Annex C (normative) Measurement of modulation transfer function (MTF) ... 21 Annex D (informative) Precision of dioptric power determination ... 25 Annex E (informative) Precision of imaging quality determination ... 26 Annex F (informative) Verification of ray trace calculations ... 27 Annex G (informative) Selected definitions ... 28 Annex H (informative) Blue light hazard function B(λ) data ... 29 Foreword YY 0290 “Ophthalmic implants - Intraocular lenses” consists of the following 9 parts: - Part 1: Terminology; - Part 2: Optical properties and test methods; - Part 3: Mechanical properties and test methods; - Part 4: Labeling and information; - Part 5: Biocompatibility; - Part 6: Shelf-life and transport stability; - Part 8: Fundamental requirement; - Part 9: Multifocal intraocular lenses; - Part 10: Phakic intraocular lenses. This is Part 2 of YY 0290. The revision of this Part adopts ISO 11979-2:1999 “Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods” and TECHNICAL CORRIGENDUM 1. The main differences between this Part and ISO 11979-2:1999 are as follows: - In Chapter 2 “Normative references”, use Chinese standards as references. Delete ISO 6328 and U.S. Mil Std 150-A-1961 that are not cited in the main text and have no corresponding Chinese national standards; - For the spectral transmittance of 4.4, add the UV limit requirements and related requirements for blue light attenuating intraocular lenses; - Supplement the provisions on test methods for 4.4 Spectral transmittance. This Part replaces YY 0290.2-1997 “Intraocular lenses. Part 2: Optical properties and their test methods”. The main differences between this Part and YY 0290.2-1997 are as follows: - Delete the requirements for astigmatism in 4.2 of YY 0290.2-1997; - Supplement the requirements for 4.3 Imaging quality; - In 4.4 Spectral transmittance, add UV limit requirements and requirements related Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods 1 Scope This Part of YY 0290 specifies requirements and test methods for certain optical properties of intraocular lenses ((IOLs). This Part is applicable to non-toric, monofocal intraocular lenses intended for implantation into the anterior segment of the human eye. This document does not include corneal implants. 2 Normative references The provisions in following documents become the provisions of this Part of YY 0290 through reference in this Part. For dated references, the subsequent amendments (excluding corrigendum) or revisions do not apply to this Part, however, parties who reach an agreement based on this Part are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document 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 defined in YY 0290.1 and GB/T 4315.1 apply. 4 Requirements 4.1 General All requirements stated below shall apply to the finished products. If applicable, the lens shall be positioned as intended for use. ......

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