EndoLab - Implant Testing Services Implant Testing

Material testing
 

Wear properties of ceramics PI-60 (ISO 6474) Shear strength of coatings ASTM F1044 and F1160 Tensile strength of coatings ASTM F1147 and ISO 13779-4 Stereological evaluation of coatings ASTM F1854 Bone cement fatigue ASTM F2118 / ISO 16402 Accelerated Aging of UHMWPE ASTM F2003 / ISO 5834-3 Bone cement specification ASTM F451 and ISO 5833 Ceramic specification ISO 13356 and ISO 6474-1/2 Abrasion Resistance of Coatings ASTM F1978 Tensile Properties of Plastics ASTM D638 Corrosion test small implant devices ASTM F2129 Small punch test ASTM F2183 Grain size analysis ASTM E112 and ISO 643 Polyethylene specification ASTM F648 Dissolution test of calcium phosphate ASTM F1926 Tension testing of nickel-titanium ASTM F2516 Galvanic corrosion ASTM F3044 PMMA molding resin ASTM F3087 Compression test of metallic cellular materials DIN 50134 Hardness of ceramics – DIN EN 843-4 / ISO 14705 Steel nonmetallic inclusions ISO 4967 Requirements for metallic skeletal pins and wires ISO 5838-1 Dimensions of Steinmann skeletal pins ISO 5838-2 Charakteristics of Kirschner skeletal wires ISO 5838-3 Tensile properties of metallic materials ISO 6892-1 Titanium alloy microstructure ISO 20160 Material properties of Ti6Al4V (extra low interstitial) ASTM F136 Wear testing of polymeric materials ASTM F732 Rigid Polyurethane Foam according to ASTM F1839 Scaffold permeability ASTM F2952 Mechanical properties of monolithic ceramics DIN EN 843-2 Conditioning of plastics ASTM D618 Surface Texture Assessment of Non-Porous Biomaterials ASTM F2791 Density test of plastics by displacement ASTM D792 Plastic film tensile test ASTM D882

Accelerated Aging of UHMWPE ASTM F2003 / ISO 5834-3

Normative References  



ASTM F2003: Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air.

ISO 5834-3: Implants for surgery – Ultra-high-molecular-weight polyethylene – accelerated ageing methods

This practice describes a laboratory procedure for accelerated aging of ultra-high molecular weight polyethylene (UHMWPE) specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its long-term chemical, physical and mechanical stability.

Although the accelerated-aging method described by this practice will permit an investigator to compare the oxidative stability of different UHMWPE materials, it is recognized that this method may not precisely simulate the degradative mechanisms for an implant during real-time shelf aging and implantation.

The accelerated aging method specified herein has been validated based on oxidation levels exhibited by certain shelf aged UHMWPE components packaged in air and sterilized with gamma radiation. The method has not been shown to be representative of shelf aging when the UHMWPE is packaged in an environment other than air. For example, this practice has not been directly correlated with the shelf life of components that have been sealed in a low-oxygen package, such as nitrogen. This practice is not intended to simulate any change that may occur in UHMWPE following implantation.  


Implant Testing - Accelerated Aging of UHMWPE ASTM F2003 / ISO 5834-3