YY/T 0290.5-2023: Ophthalmic optics - Intraocular lenses - Part 5: Biocompatibility

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Scope

This document specifies the specific requirements for the biocompatibility evaluation
of intraocular lenses (Translator NOTE. it is referred as IOLs), including the
biocompatibility evaluation requirements of materials under production process
conditions, the evaluation of physicochemical properties related to biocompatibility,
and the test methods for ocular implantation.
This document applies to intraocular lenses.

Basic Data

Standard ID	YY/T 0290.5-2023 (YY/T0290.5-2023)
Description (Translated English)	Ophthalmic optics - Intraocular lenses - Part 5: Biocompatibility
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C40
Classification of International Standard	11.040
Word Count Estimation	30,344
Date of Issue	2023-09-05
Date of Implementation	2024-09-15
Older Standard (superseded by this standard)	YY/T 0290.5-2008
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies special requirements for biocompatibility evaluation of intraocular lenses, including requirements for biocompatibility evaluation of materials under production process conditions, evaluation of physical and chemical properties related to biocompatibility, and ocular implant test methods. This standard applies to intraocular lenses.