1.1 This specification provides a characterization of the design and mechanical function
of external skeletal fixation devices (ESFDs), test methods for characterization of
ESFD mechanical properties, and identifies needs for further development of test methods
and performance criteria. The ultimate goal is to develop a specification which defines
performance criteria and methods for measurement of performance-related mechanical
characteristics of ESFDs and their fixation to bone. It is not the intention of this
specification to define levels of performance or case-specific clinical performance
of the devices, as insufficient knowledge is available to predict the consequences
of the use of any of these devices in individual patients for specific activities
of daily living. Furthermore, it is not the intention of this specification to describe
or specify specific designs for ESFDs.