Medical electrical 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.

IEC Releases Standard Update IEC 60601-2-28:2017 for X-Ray Tube Assemblies for Medical Diagnosis

The International Electrotechnical Commission (IEC) has published IEC 60601-2-28:2017

IEC Publishes 2nd Edition of First Amendment to IEC 60601 Part 2-43 for Medical Electrical Equipment

The International Electrotechnical Commission (IEC) has released IEC 60601-2-43:2010+A1:2017

IEC 60601-2-75:2017 Published for Performance of Photodynamic Therapy

The International Electrotechnical Commission (IEC) has released IEC 60601-2-75:2017

IEC Releases Standard Update for IEC 60601-2-2:2017 – Medical Electrical Equipment

The International Electrotechnical Commission (IEC) has released IEC 60601-2-2:2017

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IEC 80601-2-58:2014/AMD1:2016, Medical Electrical Equipment

The International Electrotechnical Commission (IEC) has released IEC 80601-2-58:2014/AMD1:2016.

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FDA Struggles to Meet Product Review Deadlines

Design and Operation of Antennas

FDA Warns Against Unauthorized Modifications to Medical Devices

ESD Testing Parameters

FDA Alerts the Medical Device Industry About Unreliable Third-Party Test Data

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