YY/T 0606.9-2007: Translated English of Chinese Standard. (YYT 0606.9-2007, YY/T0606.9-2007, YYT0606.9-2007): Tissue engineered medical products - Part 9: Sodium hyaluronate
https://www.chinesestandard.net, 03.06.2016 - 28 Seiten
This Part of YY/T 0606 specifies the requirements, test methods, testing rules, marks, packaging, transportation and storage of the sodium hyaluronate used in surgical implants and tissue engineered medical products. This Part applies to the sodium hyaluronate which can be used for preparing the surgical implants and tissue engineered medical products.
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10mL headspace bottle absolute ethanol Accurately WEIGH ADD water Article Biological evaluation bottle stopper brilliant blue G-250 carbazole China 2005 Edition chromatographic concentration of 1mg/mL conducted according conform Coomassie brilliant blue Cytotoxicity test dilute to 100mL dissolve and dilute distilled water engineered medical products equivalent equipment evaluation of medical expiry date EXTRACT flame ionization detector Formula GB/T Genotoxicity glucuronic acid content Hemolysis test hyaluronic acid inspection and quarantine Intrinsic viscosity mass fraction Mass of sodium medical devices microgram per gram MIX evenly mixer or equivalent molecular weight People’s Republic period of hyaluronic Pharmacopoeia of People’s prepare the sodium protein content provisions specified reagent Republic of China room temperature sample tubes sodium borate sodium hyaluronate solution spectrophotometer Standard Glucuronic Acid Standard Protein Solution standard tube Structural Unit sulfuric acid synovial fluid test The determination tissue engineered medical tube and sample type inspection unit of microgram Vortex mixer water to dissolve YY/T