International Organization for Standardization (ISO)
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ISO 17853:2011
Scope
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.
ISO 17853:2011 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