Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

Informace o normě:

Označení normy: ASTM F2313-24
Datum vydání normy: 1.12.2024
Počet stran: 10
Přibližná hmotnost: 30 g (0.07 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

Anotace textu normy ASTM F2313-24 :

This specification covers the material characteristics of virgin poly(glycolide) and poly(glycolide-co-lactide) resins with mole fractions within the specified range used in surgical implants. This does not cover packaged and sterilized finished implants fabricated from the same materials. Since some characteristics may be altered by processing techniques when used to produces a specific part or device, properties of fabricated forms of the resins should be evaluated independently using appropriate test methods. The identity of the poly(glycolide) homopolymer, poly(glycolide-co-lactide) copolymer, and poly(glycolide-co-lactide) polymer must be confirmed through nuclear magnetic resonance (NMR).

Keywords:
poly(glycolic acid), poly(glycolide), PGA, poly(glycolide:lactide), poly(glycolide-co-lactide), PLA, PGA: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),83.080.10 (Thermosetting materials)