1.1 This specification covers standards a manufacturer shall meet in the performance testing of neurosurgical head holder devices (skull clamps). 1.2 This specification covers neurosurgical head holder devices (skull clamps) made of metal (nonradiolucent) as well as neurosurgical head holder devices (skull clamps) made of plastic material (radiolucent). 1.3 This specification represents the best currently available test procedures at this time and is a minimum safety and performance standard. 1.4 This specification covers only those neurosurgical head holders (skull clamps) intended for use on humans for neurosurgical and spinal clinical applications. This specification assumes the user is well trained in the procedures and use of these devices including selection of the correct device type and accessories. 1.5 This specification describes those devices commonly known as skull clamps and accessories such as skull pins, attachments, and various adaptors. 1.6 This specification shall only describe head holder devices that provide rigid skeletal fixation of the skull by means of three skull pins that penetrate the skull during neurosurgical or spinal procedures. Two pins are typically located in two-pin rocker, whereas the force delivery component is equipped with a single pin. 1.7 Units--The values stated in both inch-pound and SI units are to be regarded separately as the standard. The values given in parentheses are for information only.
Keywords17.1neurosurgical head hold devices; skull clamp; magnetic resonance imaging (MRI) compatibility
No such standard presently exists.Back to Top