HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY 0290.9-2010 English PDF

US$359.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0290.9-2010: Ophthalmic implants. Intraocular lenses. Part 9: Multifocal intraocular lenses
Status: Obsolete
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0290.9-2010English359 Add to Cart 3 days [Need to translate] Ophthalmic implants. Intraocular lenses. Part 9: Multifocal intraocular lenses Obsolete YY 0290.9-2010

PDF similar to YY 0290.9-2010


Standard similar to YY 0290.9-2010

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 0290.9-2010 (YY0290.9-2010)
Description (Translated English) Ophthalmic implants. Intraocular lenses. Part 9: Multifocal intraocular lenses
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C40
Classification of International Standard 11.040.70
Word Count Estimation 9,918
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Quoted Standard YY 0290.1; YY 0290.2; YY 0290.3; YY 0290.4
Adopted Standard ISO 11979-9-2006, MOD
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to optical zone to provide two or more rotational symmetry IOL refractive power, and a distance (near and far) to provide additional useful vision rather than achieve the correction of aphakia main purpose intraocular lens.

YY 0290.9-2010: Ophthalmic implants. Intraocular lenses. Part 9: Multifocal 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.
Ophthalmic implants.Intraocular lenses.Part 9. Multifocal intraocular lenses ICS 11.040.70 C40 People's Republic of China Pharmaceutical Industry Standard Ophthalmic optical intraocular lens Part 9. multifocal intraocular lens Part 9. Multifocalintraocularlenses (ISO 11979-9..2006, MOD) 2010-12-27 release 2012-06-01 implementation State Food and Drug Administration issued

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). This part of the drafting unit. the State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center. This part of the main drafters. Feng Qin, Jia Xiaohang, He Tao, Qi Weiming. Ophthalmic optical intraocular lens Part 9. multifocal intraocular lens

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

4.1 General requirements This article applies to the implantation of multifocal intraocular lens (MIOLs) finished products and the final form into the human eye in the multifocal artificial crystal The physical properties of the body. 4.2 Dimensions and tolerances The requirements in YY 0290.3 apply and the additional requirements are made by the manufacturer to establish its tolerance corresponding to the optical design.

5 Optical requirements

5.1 General requirements This clause applies to the optical properties and quality requirements of multifocal intraocular lens (MIOLs) products prior to implantation. 5.2 Optical power The requirements in YY 0290.2 apply to the high power of the multifocal intraocular lens and any clear near-power. The two mutually acceptable methods of determining the power given in YY 0290.2 can be applied to the calculation of multifocal intraocular lenses. For each close-up plane, the two methods used are modified as follows. a) For the method of determining the power from the measured top focal length, the microscope is focused on the telephoto plane, from the back of the multifocal lens

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0290.9-2010_English be delivered?

Answer: Upon your order, we will start to translate YY 0290.9-2010_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 0290.9-2010_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0290.9-2010_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.