Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
NORMA vydaná dňa 15.12.2018
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Designation standards: ASTM F2579-18
Publication date standards: 15.12.2018
The number of pages: 12
Approximate weight : 36 g (0.08 lbs)
Country: American technical standard
Kategória: Technické normy ASTM
This specification covers amorphous poly(lactide) and poly(lactide-co-glycolide) resins used in the manufacture of surgical implants. Materials covered by this specification are virgin poly(lactide) and poly(lactide-co-glycolide) resins that can be fully solvated at room temperature by methylene chloride (dichloromethane) or chloroform (trichloromethane). The poly(d,l-lactide) homopolymers are amorphous and shall be composed of meso-lactide or equimolar (racemic) combinations of d-lactide and l-lactide. The poly(d,l-lactide-co-glycolide) copolymers are amorphous and shall be composed of a combination of glycolide and either meso-lactide or a racemic combination of d-lactide and l-lactide. The resins shall be manufactured in pellet, granular, powder, flake, or other form and shall conform to the chemical and physical property requirements specified. Tests for chemical identification (by infrared, proton nuclear magnetic resonance, and carbon-13 nuclear magnetic resonance spectroscopy), specific rotation, molar mass, and residual monomer, residual solvent, and heavy metal content shall be performed and shall conform to the requirements specified. Additional tests for residual catalyst and residual water content may be performed as well.
Keywords:
poly (dl-lactic acid), poly (dl-lactide), PdlLA, PGA:PLA, PLA, PLA:PGA, PLGA, polyglycolic:lactic acid, poly(glycolide-co-lactide), poly(glycolide:lactide), poly(lactic acid), polylactic:glycolic acid, poly(lactide), poly(lactide-co-glycolide), poly(lactide:glycolide), polylactide,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)