Poly(L-lactide) Resins and Fabricated Forms for Surgical Implants - In Vitro Degradation Testing
|Publication Date:||1 February 1997|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This International Standard describes methods for the determination of chemical and mechanical changes in properties of poly(L-lactide) under in vitro degradation testing conditions.
The purpose of this International Standard is to compare and/or evaluate materials or processing conditions.
This International Standard applies to poly(L-lactide) in various forms, used for the manufacture of surgical implants, including:
a) bulk material;
b) processed material;
c) finished products (packaged and sterilized implants).
The test methods specified in this International Standard are intended to determine the degradation rate and the changes in material properties of poly(L-lactide) in vitro. These in vitro methods cannot be used to predict definitely the behaviour under in vivo conditions.
NOTE - It is recommended that copolymers and/or blends from poly(L-lactide) and/or its stereoisomers also be tested according to this International Standard as long as no relevant International Standard is available.