YY 0762-2009 Translated English of Chinese Standard. YY0762-2009: Ophthalmic optics - Capsular tension ringhttps://www.chinesestandard.net, 17 mars 2014 - 13 pages This Standard specifies the scope, requirements, test methods, marking and instructions, packaging, transportation and storage of capsular tension ring. This Standard applies to one-time use of capsular tension ring. Tension ring is for aphakia to maintain capsular tension, and prevents posterior capsular from wrinkle, and is also used against the capsular bag from contraction. |
Table des matières
3 | |
Scope | 4 |
Terms and Definitions | 5 |
Requirements | 6 |
Testing Methods | 9 |
Signs and Instructions for Use | 11 |
Packaging Transportation and Storage | 12 |
13 | |
Expressions et termes fréquents
Biocompatibility capsular tension ring compression CONDUCT the test consistent with regulations Cytotoxicity Deformation and Stress Delayed-type Hypersensitivity device of Appendix Dimensions and Tolerances Dynamic Fatigue ethylene oxide Evaluation of Medical Eye Stimulation finished tension ring functional deformation functional stretch attenuation immediately and CHECK Intraocular Implantation manufacturer shall provide material of tension Measurement Instrument Mechanical Properties Medical Devices Biology methods in GB/T methods in YY micro-force meter Nominal value tolerance normative document operational head-end Ophthalmic optics IOL outer periphery Overall diameter Packaging Integrity Packaging Tension ring peripheral Positioning hole prescribed diameter radial deformation ratio of functional ratio test required and MAINTAIN residual Restoring for 20 ring diameter SAMPLE 3 tension samples as required SELECT 3 tension Standard sterile package storage container stretch The manufacturer tension ring reaches test according Test Methods Test of Intraocular Test of Sterilization tolerance of functional total diameter Validity whole arc yield characteristics