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YY 0290.2-2009 English PDF

YY 0290.2-2009 English PDF

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YY 0290.2-2009: Ophthalmic implants. Intraocular lenses. Part 2: Optical properties and test methods

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Scope

This Part of YY 0290 specifies requirements and test methods for certain optical
properties of intraocular lenses ((IOLs).
This Part is applicable to non-toric, monofocal intraocular lenses intended for
implantation into the anterior segment of the human eye.
This document does not include corneal implants.

Basic Data

Standard ID YY 0290.2-2009 (YY0290.2-2009)
Description (Translated English) Ophthalmic implants. Intraocular lenses. Part 2: Optical properties and test methods
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C40
Classification of International Standard 11.040.70
Word Count Estimation 23,258
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Older Standard (superseded by this standard) YY 0290.2-1997
Quoted Standard GB/T 4315.1; GB/T 4315.2; YY 0290.1
Adopted Standard ISO 11979-2-1999, MOD
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the primary IOL optical performance requirements and test methods. This standard applies to non-implanted in the anterior segment of the ring surface monofocal intraocular lens. This standard does not include corneal implants.


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