YY/T 0474-2025

This document describes the method for determining the chemical and/or mechanical properties of polylactide (homopolymers, copolymers, and/or blends composed of L-lactide, D-lactide, and/or D,L-lactide as structural units) under in vitro degradation conditions. This document also describes the basic physical and mechanical property evaluations required for in vitro degradation characterization of absorbable polylactide or other hydrolyzable materials and devices. This document applies to polylactide homopolymers, copolymers, and/or blends used in the production of surgical implants, including raw materials, processed materials, and final products (implants that have been packaged and sterilized). The test methods specified in this document are also used to determine the in vitro degradation rate and related material property changes of polylactide-based copolymers and/or blends containing other comonomers (such as glycolide, trimethylene carbonate, and/or ε-caprolactone). Unless specific devices have been validated, the in vitro test methods described in this document cannot be used to accurately predict the behavior of materials in vivo.