Electrical safety testing

Prerequisites

Published in Gennadi Saiko, Bringing a Medical Device to the Market A Scientist's Perspective, 2022

Electrical safety testing is carried out to evaluate the potential risks of electrical shocks to customers when using their products. This testing is conducted by an accredited laboratory and can be performed in a specialized facility or at the manufacturer’s site.

A device review of Relivion®: an external combined occipital and trigeminal neurostimulation (eCOT-NS) system for self-administered treatment of migraine and major depressive disorder

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Journal Information

Published in Expert Review of Medical Devices, 2021

Oved Daniel, Roni Sharon, Stewart J. Tepper

Performance testing, including bench testing, clinical verifications, software validation, electrical safety testing according to IEC 60601–1, and electromagnetic compatibility according to IEC 60601-1-2, all confirmed that the Relivion® complies with accepted performance standards for neurostimulation devices [47].

Electrical safety testing

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Prerequisites

A device review of Relivion®: an external combined occipital and trigeminal neurostimulation (eCOT-NS) system for self-administered treatment of migraine and major depressive disorder