骨科植入器械国内外标准比较分析

Comparison of Domestic and International Standards for Orthopedic Implants

通过对比分析骨科植入器械的ISO、ASTM和国内标准,得出以下结论:国内标准在材料、尺寸、分类与国际标准基本接轨;在植入器械疲劳性能、匹配性能、磨损性能存在较大差距。并提出了一些建设性建议。

A great deal of comparisons on domestic standards for Orthopedic implants with ISO and ASTM standards have been presented, and some conclusions have been drawn： Domestic standards for orthopedic implants coincide with ISO and ASTM standards in the items of materials, geometry and classification. There are much bigger differences in some key performances of implants such as assembly, fatigue, wear and tear and so on. Some constructive ways have been suggested.