ISO DIS 13781

Description / Abstract: This International Standard describes methods for the determination of chemical and mechanical changes in poly(lactide)-based homopolymers, copolymers, and/or blends induced under in vitro degradation testing conditions. This standard covers polymers based on L-lactide, D-lactide, and/or D, L-lactide monomeric units.

The purpose of this International Standard is to compare and/or evaluate materials or processing conditions.

This Standard also describes the fundamental physical and mechanical evaluations needed for an in vitro degradation characterization of an absorbable poly(lactide) or other hydrolysable material or device. This International Standard is applicable to poly(lactide)-based homopolymers, copolymers, and/or blends in bulk or processed forms and used for the manufacture of surgical implants, including finished products (packaged and sterilized implants).

The test methods specified in this International Standard are also intended to determine the in vitro degradation rate and related changes in material properties of polylactide-based copolymers and/or blends with various other comonomers, such as glycolid, trimethylene, carbonate, and/or ε-caprolactone. Unless otherwise validated for a specific device, these in vitro methods cannot be used to definitively predict device behaviour under in vivo conditions.