标准编号：ISO 17853:2011
中文名称：植入物材料的磨损 聚合物和金属材料磨屑 分离和表征
英文名称：Wear of implant materials — Polymer and metal wear particles — Isolation and characterization
发布日期：2011-03
标准范围
This International Standard specifies methods for sampling wear particles generated by joint replacementimplants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolateand characterize both polymer and metal wear particles from samples of tissues excised from around the jointreplacement implant, obtained at revision surgery or post mortem, and from samples of joint simulator testfluids. Some of these procedures could certainly be adapted for isolation and characterization of particles fromhuman biological fluids (e.g. synovial fluid).The methods given in this International Standard do not quantify the level of wear the implant produces;neither do they determine the amount of wear from any particular surface. This International Standard doesnot cover the biological effects of wear particles or provide a method for evaluation of biological safety.
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