Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
|Publication Date:||1 March 2011|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This International Standard 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).
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 does not cover the biological effects of wear particles or provide a method for evaluation of biological safety.