What Data Should Be Provided For The Mechanical Performance Study Of Orthopedic Implants?

The data to be provided for the mechanical performance study of orthopedic implants should include at least the following aspects: clearly define the mechanical performance study items that should be carried out to ensure that the performance of the device can meet clinical needs, and provided the reason for selecting the above study items. The study items should fully ensure the performance and use of the device as expected. For each mechanical performance item, a corresponding test method should be specified, which can be selected from test methods in existing standards; if other methods are used, their rationality and equivalence should be explained. The selection of test samples should be representative of the worst conditions for the performance of the product under application, and the basis for determining them as the worst conditions should be provided. The test data and results should be processed and analyzed and the test results should be demonstrated that the product can meet the needs of clinical use.