Risks and Controls Study for Developing Bone Plate Fixation Device Performance Standards

摘要

The presentation was given at Workshop II on Performance Standards, Committee F-4, Medical and Surgical Materials and Devices, American Society of Testing and Materials, November 28, 1979, at Williamsburg, Virginia. The objective of the study was the investigation of the risks and methods of control for bone plate fixation devices for this type of osteosynthesis device for the purpose of developing performance standards. The presentation reports on the methods used, the findings of the study, and a listing of device risks and controls for initiating standards development for bone plates. This information and data supplements the findings of the Orthopaedic Section of the Surgical and Rehabilitation Devices for osteosynthesis devices which have been recommended for Class II standards category.