Biomedical Engineering Reference
In-Depth Information
regardless of how remote and unlikely they may be. Remember that if something goes
wrong, it is the clinical staff
ff
who will have to save the patient's life!
CONCLUDING REMARKS
Applying the principles and requirements described by the safety standards is important
for even the
first engineering evaluation prototype of a medical electronic device. This is
because the biomedical equipment department of any hospital hosting the preclinical trials
will demand that the device passes, at a bare minimum, all electrical safety tests. Further-
more, since we live in a litigious society, it is a good idea to maintain good records show-
ing that careful consideration was given to the standards and regulations all the way from
the beginning of the design.
As you can appreciate from even the brief overview of limited scope presented in this
chapter, the safety and performance requirements for medical devices are many and very
stringent. However, we believe that these requirements are not enforced by regulatory
agencies with the intent of discouraging the advancement of the medical sciences. Rather,
it is our perception that applicable standards and regulations are there to help the designer
develop a product that provides true bene
fi
it to the patient at the same time that it reduces
foreseeable risks. We encourage you to pursue data that clearly demonstrate clinical e
fi
-
cacy for an idea that you may have for a medical product. In addition, we urge you to real-
ize that to be approved, new medical technology must absolutely be based on solid
physiological and technical grounds. Armed with this information, and if you can adapt to
a changing regulatory environment, we are convinced that a very receptive audience of
investors eagerly awaits to back your idea.
REFERENCES
Ackerman, B., High-Resolution Timing on a PC, Circuit Cellar INK , 24, 46-49, December 1991-
January 1992.
Association for the Advancement of Medical Instrumentation,
Safe Current Limits for
Electromedical Apparatus , ANSI/AAMI Standard ES1, 1993.
IEC-601-1,
Medical Electrical Equipment—Part 1:
General Requirements for Safety ,
1988;
Amendments 1, 1991, and 2, 1995.
IEC-601-1-1, Medical Electrical Equipment Part 1: General Requirements for Safety ; Section 1:
Collateral Standard: Safety Requirements for Medical Electrical Systems, 1992.
IEC-601-2-27, Medical Electrical Equipment Part 2: Particular Requirements for the Safety of
Electrocardiographic Monitoring Equipment , 1994.
Porr, B., EEG Preamp: Anti Alias Filter and Isolation Circuit, www.cn.stir.ac.uk/~bp1/
eegviewer/preamp/ , 2000.
Prutchi, D., LPT:Analog!—a 12-Bit A/D Converter Printer Port Adapter, Circuit Cellar INK , 67,
26-33, February 1996.
Schulze, D. P., A PC Stopwatch, Circuit Cellar INK , 19, 22-23, February-March 1991.
UL-94V, Flammability of Plastic Materials for Parts in Devices and Appliances , UL-2601-1,
Standard for Safety: Medical Electrical Equipment—Part 1: General Requirements for Safety ,
2nd ed., 1997.
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