medical equipment

Expected Service Life of Medical Electrical Equipment

The definition of “expected service life” included in IEC 60601-1 standard potentially generates confusion and misinterpretation. This article provides an analysis of the “real-life” implications of this definition and proposes some clarifications.

IMDRF Proposes Update on Post-Market Medical Device Studies

The International Medical Device Regulators Forum (IMDRF) has reportedly proposed an update to its...

IEC Releases 2nd Edition of IEC 80601-2-59:2017 for Medical Electrical Equipment

The International Electrotechnical Commission (IEC) has released IEC 80601-2-59:2017

New Edition of IEC 60601-2-50:2009+A1:2016, Standard for Medical Electrical Equipment

The International Electrotechnical Commission (IEC) has released a new edition of the standard for...

Testing to IEC60601 Standards: Leakage Current, Dielectric Breakdown, Insulation Resistance, and Ground Bond

In this Application Note, Chroma Systems Solutions takes you through requirements for testing to...

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