ISO 17853:2003 PDF

ISO 17853:2003 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 ISO 17853:2003 does not quantify the level of wear the implant produces, nor does it determine the amount of wear from any particular surface. ISO 17853:2003 does not cover the biological effect of wear debris or provide a method for evaluation of biological safety.

The method given in ISO 17853:2003 is not applicable to the measurement of poly(methyl methacrylate) (PMMA) debris.