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Standards documents can be written in several ways. The distinction between design standards and performance standards is examined here, in the special context of surgical materials and devices. The work of writing performance standards is significantly different, and that difference will affect the work of the task forces and committees of ASTM Committee F-4 on Medical and Surgical Materials and Devices. If the performance documents produced by Committee F-4 are well crafted, their usefulness will extend beyond the limits of the American Society for Testing and Materials to service in many different contents.
implant materials, standards, design standards, performance standards, medical devices, surgical devices, medical materials
Associate professor of Clinical Surgery in Orthopaedics, Dartmouth Hitchcock Medical Center, Hanover, NH