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It's simple: Engineers must be aware of the design for each medical device. The awareness of what is most critical is important. But why? The isolation required between parts with different operating voltages, to prevent against unacceptable risk, is the primary reason for the importance of creepage and clearance distances.
Specifically, creepage is the shortest distance between the path of two conductive parts of a medical device and is measures along the surface of insulation. The clearance is similar, but very different. It [creepage] is the shortest distance between two conductive parts, measured through air.
In IEC 60601-1 Third Edition, there are requirements for creepage distance and clearance, which follows the IEC "Modern Standard" approach. This approach though requires the use of six different tables for spacings and the introduction of five additional requirements to be included as part of the evaluation. But what if your company has already begun to address these requirements established by Second Edition?
"If your product meets Second Edition's creepage and clearance, then the medical product will be in compliance with the requirements for Third Edition," said Todd Konieczny, North American Medical Technical Leader. "The Third Edition requirements for creepage and clearance require less stringent parameters for operator protection – which, ultimately, allows companies to build a smaller product."
In the July 25 blog entry, the additional requirements of Creepage Distance and Clearance will be explored.
To learn more about Third Edition and or to speak with an Intertek expert on this subject matter, e-mail us at ThirdEdition@intertek.com.