YY 0762-2017: Translated English of Chinese Standard. YY0762-2017: Ophthalmic Optical - Capsular Tension Ring
https://www.chinesestandard.net, 2018 M07 21 - 13 pages
This Standard specifies requirements, test methods, label, instruction of usage, package, transport and storage of capsular tension ring. This Standard is applicable to disposable capsular tension ring (hereinafter referred to as tension ring). Tension ring can be adopted to maintain capsular tension in aphakic eyes, prevent from posterior capsule wrinkles and fight against capsular contraction.
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Biological Evaluation Capsular Tension Ring compression reaches 50 Cytotoxicity test Delayed-type hypersensitivity test described in Appendix described in GB/T diameter of positioning diameter through radial Dynamic fatigue durability Elasticity limit Ethylene Oxide Residue Evaluation of Medical extraction test fatigue durability test finished tension rings functional elasticity attenuation Functional elasticity test G in YY immediately release impose force instruction of usage Intraocular implantation test Intraocular Lenses maximum peripheral diameter maximum sectional dimension Medical Devices method described method stipulated modified Nominal value tolerance Ophthalmic Implants People’s Republic peripheral axis Pharmacopoeia positioning hole prepared in accordance Prescription Diameter Primary Packaging radial deformation reaches open distance Republic of China restored formation ring shall demonstrate shape variable specified date Standard is drafted sterility test stipulated in GB/T Surface Quality Take 3 tension Terms and Definitions Test Conduct test in accordance Test Methods test Test solution tolerance of functional utilize a clamping variable and stress Yield limit