Standard: AAMI NS28

INTRACRANIAL PRESSURE MONITORING DEVICES

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Scope:

General

This standard establishes minimum labeling, safety, and performance requirements for intracranial pressure (ICP) 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.

Inclusions

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)

(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)

Exclusions

This standard does not cover components that may be used with the ICP monitoring device to expand its therapeutic or diagnostic applications (for example, drainage bags for cerebrospinal fluid collection or computer additions for trend analysis). Neither does this standard cover tonometric devices limited to external scalp-fontanel applications. If such additions to the ICP monitoring device are supplied by the manufacturer, the manufacturer must demonstrate that they do not compromise compliance with this standard. Specifically, the manufacturer must address the possibility of physiologic alterations in the patient that might compromise the accuracy or reliability of the ICP monitor (for example, ventricular collapse might occur with use of fluid-coupled ventricular monitors during simultaneous CSF drainage and ICP

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami ns28
Publish Date: 1988-01-01
Page Count: 21
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active
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