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YY 0290.10-2009 English PDF

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YY 0290.10-2009: Intraocular lenses. Part 10: Phakic intraocular lenses
Status: Valid
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YY 0290.10-2009English149 Add to Cart 2 days [Need to translate] Intraocular lenses. Part 10: Phakic intraocular lenses Valid YY 0290.10-2009

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Standard similar to YY 0290.10-2009

YY/T 0290.5   YY 0290.8   YY 0290.2   YY/T 0290.4   YY/T 0290.6   YY/T 0290.1   

Basic data

Standard ID YY 0290.10-2009 (YY0290.10-2009)
Description (Translated English) Intraocular lenses. Part 10: Phakic intraocular lenses
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C40
Classification of International Standard 11.040.70
Word Count Estimation 5,540
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Quoted Standard YY 0290.1; YY 0290.2; YY 0290.3; YY 0290.4; YY 0466
Adopted Standard ISO 11979-10-2006, MOD
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to correct the refractive phakic intraocular lens for the primary purpose, which does not include the use of multi-focal or other optical methods to obtain the same time as hyperopia compensation phakic intraocular lenses for correcting astigmatism and phakic intraocular lens. This standard specifies the phakic intraocular lens (PIOL) in YY 0290 in other parts not given special requirements. Other requirements with normal intraocular lens.

YY 0290.10-2009: Intraocular lenses. Part 10: Phakic intraocular lenses

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Intraocular lenses.Part 10. Phakic intraocular lenses ICS 11.040.70 C40 People's Republic of China pharmaceutical industry standards Ophthalmic optics IOL Part 10. Phakic IOL (ISO 11979-10.2006, MOD) Posted 2009-06-16 2010-12-01 implementation State Food and Drug Administration issued

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. This part of the National Optical and medical instruments Standardization Technical Committee (SAC/TC103/SC1) and focal points. This section drafted by. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this section. Feng Qin, JIA Xiao Hang, He Tao, Qi Weiming. Ophthalmic optics IOL Part 10. Phakic IOL

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

4.1 General Requirements This provision applies to the clinical application of state optical characteristics and performance requirements of the phakic IOL under. 4.2 optical power YY 0290.2 The requirements apply. 4.3 image quality YY 0290.2 The requirements apply. NOTE. To determine the amount of negative power has the image quality of the phakic IOL, you may need to modify the measuring device (such as increasing the converging group, it may be a suitable Combined numerical aperture microscope objective, or other). 4.4 spectral transmittance Each type of IOL should be given at a wavelength of 300nm ~ 1100nm range for the optical power of artificial crystal -15D Like body or equivalent spectral transmittance of the recording (for example, recorded in the owner's manual or on the packaging).

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