YY 0290.9-2010Ophthalmic implants—Intraocular lenses - Part 9: Multifocal intraocular lenses (English PDF)

Foreword

YY 0290 "ophthalmic optical intraocular lens" is divided into nine parts.

- Part 1. Terminology;

- Part 2. Optical properties and test methods;

- Part 3. Mechanical properties and test methods;

- Part 4. Labels and information;

- Part 5. Biocompatibility;

- Part 6. validity and transport stability;

- Part 8. Basic requirements;

- Part 9. multifocal intraocular lens; Part 10. Crystal Eye Intraocular Lens. This section is part 9 of YY 0290.

This part of the modified use of ISO 11979-9.:2006 "ophthalmic implants intraocular lens Part 9. multifocal intraocular lens" (English version).

The main differences between this section and ISO 11979-9.:2006 are as follows.

--- its normative reference documents were modified;

--- 5.3 image quality assessment requirements were modified;

--- Change the unit cycles/mm in the original ISO international standard to lp/mm (linepair/mm);

--- delete the ISO standard in Appendix B clinical investigation part;

--- remove the ISO standard Appendix C sample size statistics.

This section consists of the National Committee for the Standardization of Optical and Optical Instruments Medical Subcommittee for Medical Optics and Instruments (SAC/TC103 / SC1).

1 Scope

This part of YY 0290 applies to intraocular lenses that provide two or more rotationally symmetrical optical powers in the optical zone, From the (near and far away) to provide additional useful vision to achieve the correction of the lensless lens for the main purpose of the intraocular lens.

Note: The term "near vision" used in this part of YY 0290 includes useful visual acuity of the declared benefit position; for example, near and/or intermediate distance.

2 Normative reference documents

The terms of this document are the terms of this part by reference to this part of YY 0290. Any reference to the date of the document, All subsequent amendments (excluding corrigenda) or revisions do not apply to this part, however, it is encouraged to enter into an agreement under this Part Of the parties to study whether the latest version of these documents can be used. For undated references, the latest edition applies to this section.

YY 0290.1 Ophthalmic optics Intraocular lens Part 1. Terminology (YY 0290.1-2008, ISO 11979-1.:2006, MOD)

YY 0290.2 Ophthalmic optical intraocular lens Part 2. Optical properties and test methods (YY 0290.2-2009, ISO 11979-2.:1999, MOD)

YY 0290.3 Ophthalmic optics Intraocular lens Part 3. Mechanical properties and test methods (YY 0290.3-2008, ISO 11979-3.:2006, IDT)

YY 0290.4 Ophthalmic optics Intraocular lens Part 4. Labeling and information (YY 0290.4-2008, ISO 11979-4. 2000, IDT)

3 Terms and definitions YY

0290.1 established terms and definitions apply to this part of YY 0290.

4 Physical requirements

5 Optical requirements