PI-89 (ISO/CD 24085-1): Implants for Surgery – Partial and total shoulder joint prosthesis – Part 1: Determination of resistance to static load of ceramic humeral heads and glenospheres

ISO/CD is a draft standard to determine ceramic heads’ fracture load for total or partial shoulder joint replacement. The current version is covered by our scope of certification as PI-89.
The test method considers the non-axial loads and the mostly non-rotationally symmetrical designs of the implants. The number of test samples is based on statistical analysis. In addition, the determination of an acceptance criterion is described.