YY/T 0474-2004 in English

本标准描述了聚L-丙交酯在体外降解试验条件下化学或机械性能变化的测定方法。本标准的目的在于比较和(或)评价材料或加工条件。本标准适用于生产外科植入物的各种形态的聚L-丙交酯。包括：a)块材；b)加工材；c)最终产品(经包装和灭菌的植入物)。本标准中所规定的试验方法用于测定聚L-丙交酯体外降解速度和材料性能的变化。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。

Scope

This standard describes a method for the determination of changes in chemical or mechanical properties of poly-L-lactide under in vitro degradation test conditions. The purpose of this standard is to compare and/or evaluate materials or processing conditions. This standard applies to various forms of poly-L-lactide for the production of surgical implants. Including: a) block material; b) processed material; c) final product (packaged and sterilized implant). The test methods specified in this standard are used to determine the in vitro degradation rate and changes in material properties of poly-L-lactide. These in vitro test methods cannot be used to reliably predict how a material will behave under in vivo conditions.