EUROLAB, with its state-of-the-art accredited laboratories and expert team, offers precise and rapid testing services within the scope of ISO 17853 testing. ISO 17853 specifies methods for sampling wear particles produced by joint replacement implants in humans and joint simulators.
This standard covers apparatus, reagents, and test methods for isolating and characterizing both polymer and metal wear particles from tissue samples removed from the joint replacement implant perimeter and samples of joint simulator test fluids obtained at revision surgery or autopsy. Some of these procedures can certainly be adapted for the isolation and characterization of particles from human biological fluids (e.g. synovial fluid).
Biological responses to wear particles contribute to the failure of joint implants through bone resorption and resulting implant loosening. To ensure that studies of wear particle effects have a uniform approach, a standardized method of particle retrieval from tissues followed by particle characterization is required. Characterization of particles produced from implants in joint simulators also provides valuable information about the wear characteristics and performance of the implant under study.
In the protocols contained in this International Standard, for the isolation and characterization of particles from both tissues and test fluids from joint simulators, particles are isolated and then dispersed using filtration or by embedding in resin for scanning electron microscopy (SEM) or transmission electron microscopy (TEM).
An alternative protocol for the isolation and characterization of metal particles from implants tested in joint simulators has recently been developed; where particles are deposited onto plates for SEM analysis, without filtration or embedding. At the time of publication of this International Standard this alternative method has not been tested for the isolation and characterization of particles from tissues and a direct comparison between the different methods is not available. For this reason, the second method is not included in detail.
EUROLAB assists manufacturers with ISO 17853 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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