MD+DI: Implementing the IEC 60601-1 Mobility Medical Electrical Equipment Standard

The July 12, 2019, edition of MD+DI online features “Implementing the IEC 60601-1 Medical Electrical Equipment Standard” written by Nigel Syrotuck, StarFish Medical Mechanical Engineering team Lead.

Subheaded “Why a 60601-1 mobility classification matters and how to choose the right one“, Nigel explains the importance, “Mobility is a big factor in the mechanical design of a medical device. On the surface are the big obvious questions: Will it move? Does it have wheels? Does it have to be small, light, and portable? But for medical devices, it’s a lot more than that. Under the IEC 60601-1 Medical Electrical Equipment standard, the mobility classification of a device defines which tests need to be conducted in order to evaluate safety in reasonably foreseeable use scenarios.”

The article features an IEC 60601-1 Mobility Medical Device Mobility flowchart to guide readers through all possible classifications and their associated tests. Other highlights include:

• What Is 60601-1 Anyway?
• How Much of the Design Is Related to 60601-1 Mobility Classification?
• What Are the Classifications and Which Designs Are Typical of Each?
• The Impact of Changes Mid-Design

Syrotuck concludes his article with this caution, “Confusion around the mobility classification of a medical device could lead to a failure to appropriately design for the relevant testing. This will very likely have massive cost and schedule repercussions. Take care to appropriately understand your device’s mobility classification early on and lay a solid foundation for a stable development program.”