Testing conditions stipulated by ISO 7206-4 are designed to facilitate valid predictions of stemmed femoral components’ in vivo performance. The specimen is first embedded in solid material, such as acrylic bone cement. This serves to mimic bone support loss, which is the compound concern that results in total catastrophic failure.
ISO 7206-4 testing conditions include a test fluid solution of sodium chloride deionized or distilled in grade 3 water for modular specimen analysis in wear study. The batch size required for these tests is currently determined at six specimens.
Through the use of these testing methods, durability and design optimization are incentivized. Should any problems be found, alterations to coatings, surface finish, or manufacturing may be the culprit that must be adjusted.