AAMI NS28:1988/(R)2015

AAMI NS28:1988/(R)2015 PDF

This standard establishes minimum labeling, safety, and performance requirements for intracranial pressure monitoring devices, whether percutaneous, fully implantable, or noninvasive. Also covered by this standard are test and calibration methods needed to establish compliance with the standard. The following components, which individually or in combination comprise ICP monitor assemblies, are within the scope of this standard when supplied by the manufacturer of the ICP monitoring device: (1) Percutaneous fluid-coupled devices, such as ventricular catheters, skull-fixated subarachnoid and subdural devices, subdural balloons and subdural catheters, and connecting tubing for percutaneous fluid-coupled devices; (2) Patient/device interfaces for remote-sensor, servomechanism-regulated devices, such as percutaneous optical, pneumatic, or electrical leads; remote transducers; internal pneumatic devices; and display modules; (3) implantable electrical transducers with percutaneous leads (strain gauges), such as implantable, diaphragm-mounted, strain-gauge transducers and implantable, passive-resistance, circuit transducers (variable inductance and capacitance); and (4) Fully implantable devices, such as variable oscillators, passive-absorption devices, and interrogators, receivers, display modules, power sources, and pressure-balancing devices for the transducers in (3).