YY 0290.5-2008: [YY/T 0290.5-2008] Ophthalmic implants. Intraocular lenses - Part 5: Biocompatibility

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Scope

This Part of YY 0290 specifies particular requirements for the biocompatibility
evaluation of materials for intraocular lenses (IOL) including the processing conditions
to produce them. These requirements include evaluation of physicochemical properties
that are relevant to biocompatibility. It also gives guidance on conducting an ocular
implantation test.

Basic Data

Standard ID	YY 0290.5-2008 (YY0290.5-2008)
Description (Translated English)	[YY/T 0290.5-2008] Ophthalmic implants. Intraocular lenses - Part 5: Biocompatibility
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C40
Classification of International Standard	11.040
Word Count Estimation	24,213
Date of Issue	2008-10-17
Date of Implementation	2010-06-01
Older Standard (superseded by this standard)	YY 0290.5-1997
Quoted Standard	GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.6; GB/T 16886.10; GB/T 16886.12; YY 0290.1; YY 0290.2; YY 0290.3; YY/T 0316; ISO 10339
Adopted Standard	ISO 11979-5-2006, MOD
Regulation (derived from)	SFDA [2008] No. 605
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the intraocular lens (IOL) biocompatibility evaluation of specific requirements, but also in the production process, including its conditions, biocompatibility evaluation requirements. These requirements include biocompatibility associated with the evaluation of the physical and chemical properties. This section also gives guidance intraocular implant testing guidelines.