【国外标准】 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components

5.1 This test method should be used to evaluate and compare different femoral and acetabular prosthesis designs to assess the damage tolerance under controlled laboratory conditions.5.2 Although the methodology described attempts to identify physiologically relevant motions and loading conditions, the interpretation of results is limited to an in-vitro comparison between different femoral and acetabular prosthesis designs regarding their ability to resist impingement damage modes (defined in 8.2) under the stated test conditions.1.1 This test method covers a procedure to simulate dynamic impingement between femoral and acetabular components in a hip replacement; the subsequent qualitative assessment of damage modes (as outlined in 8.2); and, if necessary, quantitative assessment of changes in modular component attachment strength.1.2 This test method can be used to evaluate impingement between femoral components and the following: single-piece, modular, semi-constrained, bipolar, constrained, or dual mobility acetabular components, manufactured from polymeric, metallic, or ceramic materials.1.3 The values stated in SI units are regarded as the standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.