ISO 14242-1:2009, titled "Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines," is a technical standard developed by the International Organization for Standardization (ISO).
Scope of ISO 14242-1:2009
The scope of ISO 14242-1:2009 is to provide guidelines and parameters for testing the wear resistance of total hip-joint prostheses. The standard specifies the loading and displacement conditions to be used with wear-testing machines in order to simulate real-life wear and tear that occurs in a patient's body.
Key features of ISO 14242-1:2009
ISO 14242-1:2009 provides detailed guidance on the design of wear-testing machines, the selection of appropriate materials for test specimens, and the test procedures to be followed. The standard defines the parameters for cyclic loading, angular displacement, and axial displacement that should be applied during wear testing. It also outlines the criteria for evaluating the wear performance of hip-joint prostheses based on the volume of debris generated and the damage observed on the test specimens.
Benefits of ISO 14242-1:2009
Adherence to ISO 14242-1:2009 ensures that hip-joint prostheses manufacturers produce products that meet certain quality standards regarding their wear resistance. By following the guidelines outlined in the standard, manufacturers can accurately assess the lifespan and durability of their products before they are implanted in patients. This helps in improving the overall safety and performance of total hip-joint prosthesis, ultimately benefiting the patients who receive them.