ISO 17853:2011
Wear of implant materials — Polymer and metal wear particles — Isolation and characterization
ISO 17853:2011 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).
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1 Scope
2 Terms and definitions
3 Principle, reagents and apparatus
3.1 Principle
3.2 Reagents
3.3 Apparatus
4 Methods of sampling and analysis of polymer and metal wear particles from tissue samples
4.1 Storage and preparation of samples
4.2 Procedure for polymer particle isolation
4.2.1 Tissue digestion
4.2.2 Purification of the polymer particle yield
4.2.2.1 General
4.2.2.2 Purification of polymer particles by high-speed centrifugation
4.2.2.3 Purification of polymer particles by ultracentrifugation
4.3 Procedure for metal particle isolation
4.4 Collection of particles
4.4.1 Polyethylene particles
4.4.2 Metal particles
4.5 Particle size and shape characterization
4.5.1 Polyethylene particles
4.5.2 Metal particles
4.5.2.1 General
4.5.2.2 TEM analysis
4.5.2.3 SEM analysis
4.6 Particle identification
4.6.1 Polyethylene particles
4.6.2 Metal particles
5 Methods of sampling and analysis of polymer and metal particles from joint simulator lubricants
5.1 General
5.2 Procedure for polymer materials — For example UHMWPE and polyetheretherketone (PEEK)
5.2.1 General
5.2.2 Serum digestion with hydrochloric acid
5.2.3 Serum digestion with NaOH
5.2.4 Collection of particles
5.2.5 Particle size and shape characterization
5.2.6 Particle identification
5.3 Procedure for metal particles
5.3.1 General
5.3.2 Serum digestion
5.3.3 Collection of particles
5.3.4 Particle size and shape characterization
5.3.4.1 General
5.3.4.2 TEM analysis
5.3.4.3 SEM analysis
5.3.5 Particle identification
5.4 Procedure for ceramic particles
6 Test report
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1 Scope
2 Terms and definitions
3 Principle, reagents and apparatus
3.1 Principle
3.2 Reagents
3.3 Apparatus
4 Methods of sampling and analysis of polymer and metal wear particles from tissue samples
4.1 Storage and preparation of samples
4.2 Procedure for polymer particle isolation
4.2.1 Tissue digestion
4.2.2 Purification of the polymer particle yield
4.2.2.1 General
4.2.2.2 Purification of polymer particles by high-speed centrifugation
4.2.2.3 Purification of polymer particles by ultracentrifugation
4.3 Procedure for metal particle isolation
4.4 Collection of particles
4.4.1 Polyethylene particles
4.4.2 Metal particles
4.5 Particle size and shape characterization
4.5.1 Polyethylene particles
4.5.2 Metal particles
4.5.2.1 General
4.5.2.2 TEM analysis
4.5.2.3 SEM analysis
4.6 Particle identification
4.6.1 Polyethylene particles
4.6.2 Metal particles
5 Methods of sampling and analysis of polymer and metal particles from joint simulator lubricants
5.1 General
5.2 Procedure for polymer materials — For example UHMWPE and polyetheretherketone (PEEK)
5.2.1 General
5.2.2 Serum digestion with hydrochloric acid
5.2.3 Serum digestion with NaOH
5.2.4 Collection of particles
5.2.5 Particle size and shape characterization
5.2.6 Particle identification
5.3 Procedure for metal particles
5.3.1 General
5.3.2 Serum digestion
5.3.3 Collection of particles
5.3.4 Particle size and shape characterization
5.3.4.1 General
5.3.4.2 TEM analysis
5.3.4.3 SEM analysis
5.3.5 Particle identification
5.4 Procedure for ceramic particles
6 Test report