This International Standard specifies methods for sampling wear debris generated by total joint prostheses in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate, characterize and quantify both polymer and metal wear debris from samples of tissue excised from around the joint prosthesis, obtained at revision surgery or post mortem, and from samples of joint-simulator test fluids.
The method given in this International Standard does not quantify the level of wear the implant produces, nor does it determine the amount of wear from any particular surface. This International Standard does not cover the biological effect of wear debris or provide a method for evaluation of biological safety.
The method given in this International Standard is not applicable to the measurement of poly(methyl methacrylate) (PMMA) debris.
ISO 17853:2003 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