YY 0290.2-2021Ophthalmic optics - Intraocular lenses - Part 2: Optical properties and test methods (English PDF)

Foreword

All technical requirements of this standard are mandatory.

YY 0290 "Ophthalmic optics - Intraocular lenses" is divided into 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 Part is the Part 2 of YY 0290.

This part was drafted in accordance with the rules given in GB/T 1.1-2009.

This Part replaces YY 0290.2-2009 "Ophthalmic implants - Intraocular lenses - Part 2.

Optical properties and test methods". Compared with YY 0290.2-2009, the main technical changes are as follows, except editorial modifications.

- MODIFY the description of the scope of application (see Chapter 1; Chapter 1 of the 2009 edition);

- MODIFY the normative references (see Chapter 2; Chapter 2 of the 2009 edition);

- MODIFY the content of the general provisions, deleting the original two notes (see 4.1; 4.1 of the 2009 edition);

- ADD the power tolerance requirements of toric intraocular lens, multifocal intraocular lens, accommodating intraocular lens (see 4.2.2, 4.2.3, 4.2.4);

- ADD the image quality overview, MTF measurement using model eye 2, toric intraocular lens, multifocal intraocular lens, accommodating intraocular lens, image quality requirements for combination of optical principles (see 4.3.1, 4.3.2.4, 4.3.3, 4.3.4, 4.3.5, 4.3.6);

- MODIFY the spectral transmittance requirements, making adjustment of the structure, which is described in clauses (see 4.4; 4.4 of the 2009 edition);

- DELETE the color vision impact analysis and the reduction degree of blue light radiation hazards (see 4.4; 4.4 of the 2009 edition);

- DELETE the Appendix G and Appendix H (Appendix G and Appendix H of the 2009 edition);

- ADD the determination of power and axial error of toric intraocular lens, determination of power of multifocal intraocular lens, determination of power of accommodating intraocular lens (see A.5, A.6, A.7);

- ADD the resolution measurement of toric intraocular lens, resolution measurement of multifocal intraocular lens, optical resolution measurement of accommodating intraocular lens (see B.7, B.8, B.9);

- ADD the model eye 2, MTF measurement of toric intraocular lens, MTF measurement of multifocal intraocular lens, MTF measurement of accommodating intraocular lens (see C.3.2, C.6, C.7, C.8).

This Part uses the redrafting method, to revise and adopt ISO 11979-2:2014 "Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods" (English version). There are technical differences between this Part and ISO 11979-2:2014. The clauses, which are involved in these differences, have been marked by a vertical single line (|), in the outer margin position.

The technical differences, between this Part and ISO 11979-2:2014, as well as the reasons are as follows.

- Regarding the normative references, this standard has made adjustments with technical differences, to adapt to the technical conditions of China. The adjustments are specifically reflected in "2 Normative references". The specific adjustments are as follows.

- USE GB/T 4315.1, which modifies and adopts the international standard, to replace ISO 9334;

- USE GB/T 4315.2, which modifies and adopts the international standard, to replace ISO 9335;

- USE GB/T 9045-2006, which identically adopts the international standard, to replace ISO 6328:2000;

- USE YY 0290.1, which modifies and adopts international standard, to replace

ISO 11979.1;

- USE YY 0290.3, which modifies and adopts the international standard, to replace ISO 11979.3;

- USE YY 0290.4, which identically adopts the international standard, to replace ISO 11979.4;

- For the spectral transmittance in 4.4, ADD the relevant requirements for the UV limit value, to enhance the enforceability of the standard;

- MAKE supplement to the test method requirements of spectral transmittance in 4.4, which is convenient for users to refer to;

- DELETE the 4.3.7 Exception clause; the content of the clause is added to 4.3.1 Overview. This Part makes the following editorial changes.

- ADD the Appendix D, Appendix E, Appendix F as informative appendixes, which are convenient for users to understand and refer to.

1 Scope

This Part specifies the main optical performance requirements and test methods of intraocular lenses (IOLs).

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)

3 Terms and definitions

The terms and definitions, which are defined in YY 0290.1 and GB/T 4315.1, apply to this document.

4 Requirements

Any method in Appendix A can be used to determine the focal power of the highest power meridian, the lowest power meridian, the equivalent spherical power of the toric intraocular lens.

Appendix A (Normative) Measurement of optical power

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).

Appendix B (Normative) Measurement of resolution

This Appendix presents principles, devices, and methods applicable to the measurement of intraocular lens resolution.

Appendix C (Normative) Measurement of MTF

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.