Biomedical Engineering Reference
In-Depth Information
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Figure 8.48 Schematic diagram of a battery-powered fibrillator. A 555 timer IC generates a 50-Hz square wave. This signal drives paired
CMOS buffers. This output stage is actually a full bridge which causes doubling of the effective voltage across the heart.
draft form, they are very instructive as to the speci
fi
c methods applied to the design and
testing of implantable pacemakers and de
fi
brillators:
• prEN-45502-2-1, Active Implantable Medical Devices Part 2-1: Particular
Requirements for Active Implantable Medical Devices Intended to Treat
Bradyarrhythmia (Cardiac Pacemakers) , Final Draft, January 2001
• prEN-45502-2-2, Active Implantable Medical Devices Part 2-2: Particular
Requirements for Active Implantable Medical Devices Intended to Treat
Tachyarrhythmia (Includes Implantable De
fi
brillators), 1998
On the U.S. side, the FDA has not yet adopted a set of standards harmonized with
EN-45502. O
cially, the FDA still refers manufacturers to a guidance document written
in the 1970s:
• Donald F. Dahms, Implantable Pacemaker Testing Guidance, FDA FOD#383, posted
January 12, 1990, available at www.fda.gov/cdrh/ode/doc383.pdf
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