This International Standard specifies methods for sampling wear particles generated by joint 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 tissue excised from around the joint
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.
ISO 17853:2010 history
2011ISO 17853:2011 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
2010ISO 17853:2010 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
2004ISO 17853:2003/Cor 1:2004 Wear of implant materials - Polymer and metal wear particles - Isolation, characterization and quantification; Technical Corrigendum 1
2003ISO 17853:2003 Wear of implant materials - Polymer and metal wear particles - Isolation, chacterization and quantification