We’re all aware of the importance of safety testing for medical products, both for implantable devices and external devices used to monitor or sustain us when we’re in the hospital. In the past, emphasis has been on the hardware-safety aspects of external medical equipment. Are they foolproof? Are there built-in safety mechanisms that prevent the device from causing harm through electrical shock or other forms of electrical or electronic malfunction?

Until a few years ago, little thought was given to the software that is an increasingly crucial part of these devices. Over time, however, the software that controls many electronic diagnostic and life-critical electronic equipment has grown in importance, to the point where a software failure could be just as catastrophic, and life threatening, as a hardware failure. A software crash on your laptop simply means a reboot. A software crash on a piece of equipment helping to keep a patient alive is another problem altogether.

Fortunately, the issue has not gone unnoticed. In 2006, the International Electrotechnical Commission (IEC) published IEC 62304--“Medical device software--Software life-cycle processes.”

As described by the IEC, the standard:

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