ANSI/AAMI NS28:1988/(R) 2006

Intracranial pressure monitoring devices

ASTM F1089

Corrosion of surgical instruments

ASTM F2528

Enternal feeding devices

ASTM F3014 (PI-94)

Standard test method for penetration testing of needles used in surgical sutures

ISO 11608

Pen-injectors and needle-based injection systems

ISO 11953

Dentistry - Implants - Clinical performance of hand torque instruments

ISO 13402

Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure

ISO 13926-1

Glass cylinders for pen injectors

ISO 16061

Instruments for non-active surgical implants

PI-100

Bone anchoring systems

Intracranial pressure monitoring devices

Normative References

ANSI/AAMI NS28:1988/(R) 2006 – Intracranial pressure monitoring devices  

This standard establishes minimum labeling, safety, and performance requirements for intracranial pressure (ICP) monitoring devices. Endolab® has developed a multi station tester that allows for measurement of the frequency response, slew rates, time constants, drift and fatigue properties of the device.  

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Dipl. Ing. Christian Findeiss

Head of Fatigue Testing & Material Analysis, Head of Vascular Testing