ISO 13781:2017 外科移植物 聚交酯（lactide）树脂、共聚物和成形品 在玻璃器内的退化试验

标准编号：ISO 13781:2017

中文名称：外科移植物 聚交酯（lactide）树脂、共聚物和成形品 在玻璃器内的退化试验

英文名称：Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing

发布日期：2017-07

标准范围

ISO 13781:2017描述了在体外降解测试条件下测定聚（丙交酯）基均聚物、共聚物和/或共混物中诱导的化学和机械变化的方法。该文献涵盖基于L-丙交酯、D-丙交酯和/或D，L-丙交酯单体单元的聚合物。本文件的目的是比较和/或评价材料或加工条件。该文件还描述了可吸收聚（丙交酯）或其他可水解材料或装置的体外降解表征所需的基本物理和机械评估。ISO 13781:2017适用于散装或加工形式的聚（丙交酯）基均聚物、共聚物和/或共混物，用于制造外科植入物，包括成品（包装和灭菌的植入物）。本文中规定的测试方法还旨在确定聚丙交酯基共聚物和/或与各种其他共聚单体(例如乙交酯、三亚甲基、碳酸酯和/或ε-己内酯)的共混物的体外降解速率和材料性质的相关变化。除非针对特定器械进行了其他验证，否则这些体外方法不能用于明确预测体内条件下的器械行为。

ISO 13781:2017 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 document covers polymers based on L-lactide, D-lactide, and/or D, L-lactide monomeric units.The purpose of this document is to compare and/or evaluate materials or processing conditions. This document 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.ISO 13781:2017 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 document 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.

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