标准摘要
[中文适用范围]： 本国际标准规定了人体和关节模拟器中关节置换植入物产生的磨损颗粒的采样方法。 它规定了从关节置换植入物周围切除的组织样本、翻修手术或尸检时获得的组织样本以及关节模拟器测试液样本中分离和表征聚合物和金属磨损颗粒的设备、试剂和测试方法。 其中一些程序当然可以适用于从人体生物体液（例如滑液）中分离和表征颗粒。 本国际标准中给出的方法并未量化植入物产生的磨损程度；它们也不能确定任何特定表面的磨损量。 本国际标准不涵盖磨损颗粒的生物效应，也不提供生物安全性评价方法。 [外文原描述]： ISO 17853:2011 specifies methods for sampling wear particles generated by joint replacement implants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate and characterize both polymer and metal wear particles from samples of tissues excised from around the joint replacement implant, obtained at revision surgery or post mortem, and from samples of joint simulator test fluids. Some of these procedures could certainly be adapted for isolation and characterization of particles from human biological fluids (e.g. synovial fluid).
英文名称Wear of implant materials — Polymer and metal wear particles — Isolation and characterization