YY 0290.5-2008 (English Version) PDF

Scope: This part of YY 0290 specifies the special requirements for the biocompatibility evaluation of intraocular lens (IOL) materials, including the requirements for the biocompatibility evaluation of materials under the conditions of the production process. These requirements include the evaluation of physicochemical properties relevant to biocompatibility. This section also gives guidance on testing intraocular implants.

YY 0290.5-2008 Referenced Document

GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2: Animal welfare requirements
GB/T 16886.3-2008 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation
ISO 10339:1997 Ophthalmic optics - Contact lenses - Determination of water content of hydrogel lenses
YY 0290.1-2008 Ophthalmic implants.Intraocular lenses.Part 1:Terminology
YY 0290.2-2009 Ophthalmic implants.Intraocular lenses.Part 2:Optical properties and test methods*， 2009-06-16 Update
YY 0290.3-2008 Ophthalmic implants.Intraocular lenses.Part 3:Mechanical properties and test methods
YY/T 0316-2008 Medical devices.Application of risk management to medical devices

2008 YY 0290.5-2008 Ophthalmic implants.Intraocular lenses.Part 5:Biocompatibility
1997 YY 0290.5-1997 Intraocular lenses.Part 5:Biocompatibility