These test devices are used to create signals and capture responses from electronic Devices Under Test (DUTs). The proper operation of the DUT can be proven or faults in the device can be traced, repaired, and certified calibration. In order to increase patient safety and reducing the risks of legal liabilities in case of a patient mishap or accident shown to be the investigative cause due to faulty or un-calibrated test equipment.
These testing devices must have a traceable calibration in accordance to the National Institute of Science and Technology (NIST), National Metrology Institute (NMI), and comply with international standards ( i.e. ISO 9001:2008 registered, ISO/IEC 17025:2005 accredited, and ANSI/NCSL Z-540.1-1994 compliant.). Traceable to a national standard means an instrument is calibrated at either the National Institute of Standards and Technology (NIST) or at a calibration laboratory that participates in a proficiency program in accordance with NIST at least once every 2 years and the results of the proficiency test conducted within 24 months of calibration show agreement within a percentage of the national standards range.