YY/T 0652-2016 (English Version) PDF

Scope: This standard specifies methods for sampling wear debris generated from joint replacement implants implanted in the human body and in simulators. This standard specifies instruments, reagents and test methods for the isolation and characterization of polymeric and metallic wear debris derived from tissue removed around joint replacement implants or joint simulator lubricants during revision surgery or post-mortem. Some of these steps may be applicable to the isolation and characterization of wear debris in human body fluids (e.g., joint synovial fluid). The extent of wear produced by implants is not quantified in this standard; nor is the amount of wear on any particular surface specified. This standard does not cover biological responses to wear debris, nor does it include methods for assessing biosafety.

YY/T 0652-2016 history

2016 YY/T 0652-2016 Wear of implant materials.Polymer and metal wear particles.Isolation and characterization
2008 YY/T 0652-2008 Wear of implant materials.Polymer and metal wear particles.Isolation,characterization and quantification