Title :
Why does the FDA concern itself with ESD?
Author :
Bryan, Eugene O.
Author_Institution :
US Food & Drug Adm., Rockville, MD, USA
Abstract :
When electrostatic discharge (ESD) affects the safety or effectiveness of medical devices, the Food and Drug Administration (FDA) is concerned. Problems involving ESD and medical devices are presented, and a simple reporting procedure that anyone can use to relate their experience or express concern is described.
Keywords :
biomedical electronics; biomedical equipment; electrostatic discharge; safety; ESD; US FDA; US Food and Drug Administration; electrostatic discharge; medical devices; reporting procedure; safety; Drugs; Electrostatic discharge; Safety devices;
Conference_Titel :
Electrical Overstress/Electrostatic Discharge Symposium Proceedings, 1995
Conference_Location :
Phoenix, AZ, USA
Print_ISBN :
1-878303-59-7
DOI :
10.1109/EOSESD.1995.478268
