標準號：ISO 15814-1999
中文標準名稱：外科植入物.聚合交脂基共聚物及混料.體外降解試驗
英文標準名稱：Implants for surgery - Copolymers and blends based on polylactide - In vitro degradation testing
標準類型：C45
發(fā)布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C45
國際標準分類號：11.040.40
適用范圍：This International Standard is applicable to copolymers and/or blends based on polylactide, in bulk or processed forms, used for the manufacture of surgical implants. This International Standard describes methods for the determination of chemical and mechanical changes in the properties of these copolymers and/or blends under in vitro degradation testing conditions. The test methods specified in this International Standard are intended to determine the degradation rate and the changes in material properties of polylactide-based copolymers and/or blends with various comonomers (for example glycolid, trimethylene carbonate, ε-caprolactone) in vitro. These in vitro methods cannot be used to predict definitely the behaviour of these materials under in vivo conditions. The purpose of this International Standard is to compare and/or evaluate materials or processing conditions.