YY 0762-2017 Translated English of Chinese Standard. YY0762-2017: Ophthalmic Optical - Capsular Tension Ring
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.
Terms and Definitions
Label and Instruction of Usage
Package Transport and Storage
Biological Evaluation Capsular Tension Ring compression reaches 50 Cytotoxicity test described in Appendix described in GB/T diameter through radial distance l2 open 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 immediately release impose force instruction of usage Intraocular implantation test Intraocular Lenses l2 open distance maximum peripheral diameter maximum sectional dimension Medical Devices method described method stipulated micro-force measuring instrument modified Nominal value tolerance Ophthalmic Implants Oxide Residue Test People’s Republic peripheral axis Pharmacopoeia positioning hole prepared in accordance prescribed diameter Primary Packaging radial deformation reaches 70 Republic of China 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 torsion reaches open variable and stress Yield limit