Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
NORMA vydána dne 1.2.2022
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Designation standards: ASTM F1925-22
Publication date standards: 1.2.2022
The number of pages: 9
Approximate weight : 27 g (0.06 lbs)
Country: American technical standard
Kategorie: Technické normy ASTM
This specification covers virgin poly(L-lactic acid) resin (PLLA resin) intended for use in surgical implants. This specification does not cover stereoisomeric compositions based on various D, L, or DL copolymer ratios. This specification addresses material characteristics of virgin poly(L-lactic acid) resin and does not apply to packaged and sterilized finished implants fabricated from this material. The virgin polymer shall be a homopolymer of L-lactide with the prescribed density. The molecular mass of the virgin polymer shall be indicated by relative solution viscosity (in chloroform). In addition, the weight average molecular mass and molecular mass distributions may be determined by gel permeation chromatography The virgin polymer shall be identified as a polylactide by infrared or 1H-NMR spectroscopy. Typical infrared transmission and 1H-NMR spectra are shown. The virgin polymer shall have a specific optical rotation (in dichloromethane) and residual monomer content within the prescribe values, and shall conform to the chemical and physical property requirements specified for: residual solvent, residual water, residual tin, heavy metals, and sulfated ash. The following test methods shall be used: (1) Karl-Fischer titration and (2) atomic absorption-emission (AA) spectroscopy or inductively coupled plasma (ICP) spectroscopy. Considerations for biocompatibility of the material from a human implant perspective is also given.
Keywords:
PGA:PLA, PLA, PLA:PGA, PLGA, PlLA, polyglycolic:lactic acid, poly(glycolide:lactide), poly(lactic acid), polylactic:glycolic acid, polylactide, poly(lactide), poly(lactide:glycolide), poly(l-lactic acid),, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics),83.080.20 (Thermoplastic materials)