McNeice G M
Med Prog Technol. 1977 Sep 29;5(2):67-72.
This paper discusses the proliferation of medical devices and focusses its attention on the rapid development of orthopedic implants and the attempts by federal authorities to provide standards and recommended practices. The very important aspect of implant assessment based on mechanical testing is discussed and shown to be completely lacking. Current attempts to maintain quality and safety of orthopedic implants are discussed. One test configuration for femoral components of total hip replacement is offered as an example of methods that should be established to verify a particular design in conjunction with efforts to control material composition.
本文讨论了医疗设备的激增，并将重点放在骨科植入物的快速发展以及联邦当局制定标准和推荐做法的尝试上。文中讨论了基于机械测试的植入物评估这一非常重要的方面，并指出其完全缺失。还讨论了目前为维持骨科植入物的质量和安全性所做的努力。作为应建立的方法的一个例子，给出了全髋关节置换股骨部件的一种测试配置，以便结合控制材料成分的工作来验证特定设计。
