Biomedical Engineering Reference
In-Depth Information
However, this document simply outlines the areas in which implantable pacemakers
should be tested (e.g., electrical characterization, interference, biocompatibility, animal
testing) so that they can be considered safe for human implant. This document does not
provide the speci
c performance requirements or testing methods available in the EN-
45502 series of standards. This is not to say that the FDA doesn't expect to see much,
much
more than what the guidance document sketches. Until a standard is adopted by FDA,
however, it is up to the manufacturers to
fi
fi
find ways of justifying the performance of
their devices and to
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find ways of testing the devices for safety and e
ff
ectiveness to satisfy
the FDA.
Nonimplantable pacemakers and de
fi
brillators are also governed by particular standards:
• IEC-601-2-31,
Particular Requirements for the Safety of External Cardiac Pacemak-
ers with Internal Power Source
, 1994, speci
es the particular safety requirements for
external pacemakers powered by an internal electrical power source. Applies also to
patient cables but does not apply to equipment that can be connected directly or indi-
rectly to a power line.
• IEC-601-2-4,
Particular Requirements for the Safety of Cardiac De
fi
fi
brillators and
Cardiac De
fi
brillator Monitors
, 1983, speci
fi
es requirements for the safety of cardiac
de
fi
brillators and cardiac de
fi
brillator monitors incorporating a capacitive energy
storage device.
• ANSI/AAMI DF2,
Cardiac De
brillator Devices
, 1989, provides minimum labeling,
performance, and safety requirements for cardiac de
fi
brillator devices. Requirements
for performance cover energy range, limited energy output, energy accuracy, pulse
shape and duration, controls and indicators, energy-level indicator, reduce-charge
capability, paddle electrode contact area, and other characteristics.
• AAMI DF39,
Automatic External and Remote Control De
fi
brillators
, 1993, covers
testing and reporting performance results of automatic external de
fi
brillators, prima-
rily through description of the performance for the arrhythmia detection component.
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REFERENCES
AAMI,
AAMI/ANSI Standard HF18: Electrosurgical Devices, Annex B
, 1994.
Bocka,
J. J.,
External Transcutaneous Pacemakers,
Annals of Emergency Medicine
,
18(12),
1280-1286, 1989.
Hoekstein, K. N., and G. F. Inbar,
Cardiac Stroke Volume Estimation from Two Electrode Electrical
Impedance Measurements
, EE Publication 911, Technion Institute of Technology, Haifa, Israel,
1994.
Irwin, D. D., S. Rush, R. Evering, E. Lepeschkin, D. B. Montgomery, and R. J. Weggel, Stimulation
of Cardiac Muscle by a Time-Varying Magnetic Field,
IEEE Transactions on Magnetics
, 6(2),
321-322, 1970.
Prutchi, D., Rate Responsive Cardiac Pacemaker with Filtered Impedance Sensing and Method, U.S.
patent 5,431,772, July 2, 1996.
Prutchi, D., and M. Norris, Electro-optically Driven Solid State Relay System, U.S. patent
6,335,538, January 1, 2002.
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