YY 0290.10-2009Ophthalmic optics - Intraocular lenses - Part 10: Phakic intraocular lenses (English PDF)

Foreword

YY 0290 "IOL optics" is divided into nine sections.

--- Part 1. Terminology;

--- Part 2. Optical properties and test methods;

--- Part 3. Mechanical properties and test methods;

--- Part 4. Labelling and information;

--- Part 5. biocompatibility;

--- Part 6. Validity of the transport and stability;

--- Part 8. basic requirements;

--- Part 9. multifocal intraocular lens;

--- Part 10. Phakic IOL. This is Part 10 YY 0290 of.

The partial modification of the use of ISO 11979-10:2006 "Part 10 ophthalmic intraocular lens implants. phakic intraocular lens Shaped body. " This part of ISO 11979-10:2006 The main differences are as follows.

--- Its normative references have been modified;

--- Optical spectral transmission of the content requirements detailed requirements;

--- Optical imaging quality requirements in the comments directly to the requirements;

--- Mechanical requirements to determine their position size based on the contents of phakic intraocular lens design principle be refined;

--- Delete ISO standards in Appendix A and Appendix B of clinical investigation section sample size statistics.

1 Scope

This section applies to YY 0290 to correct the refractive phakic intraocular lens for the main purpose, which does not include the use of multiple Coke or other method of obtaining the same time as the optical compensation myopia phakic intraocular lens for correcting astigmatism and phakic intraocular lens Like body.

This section gives a phakic intraocular lens (PIOL) special requirements in other parts of the YY 0290 which was not given. other With the general requirements of the intraocular lens.

2 Normative references

The following documents contain provisions which, through reference in this section YY 0290 constitute provisions of this section. Cited documents dated, its All subsequent amendments (excluding corrections) or revisions do not apply to this section, however, encourage an agreement under this section Parties to study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

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

YY 0290.2 IOL optics - Part 2. Optical properties and test methods (YY 0290.2-2009, ISO 11979-2:1999, MOD)

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

YY 0290.4 optics IOL Part 4. Labelling and information (YY 0290.4-2008, ISO 11979-4. 2000, IDT)

YY 0466 medical equipment used with medical device labels, signs and symbols provide information (YY 0466-2003, ISO 15233. 2000, IDT)

3 Terms and Definitions

YY 0290.1 terms and definitions established in this section apply to YY 0290.

4 Optical requirements