Lucideon, the international materials technology company, has published a new white paper titled ‘Hip and Knee Wear Testing – What The Standards Don’t Tell You’.
The white paper highlights areas of hip and knee implant wear testing that remain somewhat ambiguous within ISO standardization, and aims to give manufacturers an understanding of the kinds of pre-clinical work they may wish to undertake, along with justifications for regulatory submissions.
ISO standards provide a number of well detailed testing procedures for wear testing implants under loading, but for less typical requirements the standards are not always clear.
The white paper, written by Ramiro Ramirez, Wear Test Engineer at Lucideon, provides examples of scenarios where non-standard testing may need to be performed. All testing must be detailed and justified for regulatory submission, a point that is taken into consideration within the paper.
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Ramiro Ramirez said: “We do a lot of non-standardized testing for our orthopedic partners. While we find that the ISO standards offer a lot of detail, they are not always easy to apply to every test. We often need to adapt test rigs and methods to suit the implant in question, but of course proving the efficiency and safety of the device is always a top requirement.
“We are used to designing customized methods that both fit within the requirements of the ISO standards and show the fitness of the implant when it comes to regulatory submission. This white paper highlights the need for this kind of testing and will give manufacturers of hip and knee implants an insight into to the kind of things that must be taken into consideration.”
Lucideon offers testing and materials development services to a range of sectors including healthcare. The company provides implant manufacturers with dedicated wear and fatigue testing solutions including tribological analysis, surface evaluation, materials characterization, and failure, debris and wear pattern analysis.
Lucideon’s dedicated wear testing laboratories are supported by its surface science capabilities to visualize the effects of motion and wear on the surface of implants.