YY/T 0473-2004 in English

本标准适用于生产外科植入物用的聚交酯共聚物和(或)共混物的块材或加工材。本标准描述了在体外降解条件下测定这些共聚物和(或)共混物化学和(或)机械性能的变化。本标准中所规定的试验方法，用于在体外测定含有不同共聚单体(如乙交酯、三亚甲基碳酸酯、ε-内酯)的聚交酯基的共聚物和(或)共混物的降解速度和材料特性的变化。这些体外试验方法不能用来确切地预测材料在体内条件下的行为。本标准的目的是在于比较和(或)评价材料或加工条件。

Scope

This standard applies to the production of blocks or processed materials of polylactide copolymers and/or blends for surgical implants. This standard describes the determination of changes in the chemical and/or mechanical properties of these copolymers and/or blends under in vitro degradation conditions. The test method specified in this standard is used for the in vitro determination of polylactide-based copolymers and/or copolymers containing different comonomers (such as glycolide, trimethylene carbonate, ε-glycolide). Degradation rate of the mixture and changes in material properties. These in vitro test methods cannot be used to reliably predict how a material will behave under in vivo conditions. The purpose of this standard is to compare and/or evaluate materials or processing conditions.