March 12, 2012 -- Two primary concerns dominate medical device and system testing. One is the frequent presence of high voltages, making the test process itself an area of concern, with potential safety issues for patients and technicians during diagnostic endeavors such as X-rays and CT scans. These voltages become even more critical in implantable devices such as pacemakers.

But the real elephant in the room is the recognized standard that governs the process; the International Electrotechnical Commission's (IEC's) 60601-1 technical standard for the safety and effectiveness of electrical medical equipment. IEC 60601-1 is a big, broad mandate encompassing a general standard, about 10 collateral standards, and approximately 60 particular standards.

In this report, we look at some of the particular issues surrounding high-voltage test, such as breakdown voltages and leakage currents. We also look at the transition that's now ongoing from the second edition of the IEC 60601-1 standard to implementation of the third edition and what that means for the process of testing electrical medical equipment.

By David Maliniak. (Maliniak is Electronic Design Magazine's EDA and Test and Measurement Editor.)