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Usability Engineering for Medical Devices using Artificial Intelligence and Machine Learning Technology

Year: 2024

Type: article

Abstract: This paper explores how to apply the established IEC 62366-1 usability engineering process for safe and effective use of Artificial Intelligence (AI) and machine learning in medical devices. We identify unique factors specific to AI technology that can impact safe use and integrate these considerations into a comprehensive analysis of IEC 62366-1. This analysis results in a step-by-step guide with practical recommendations for identifying, evaluating, and mitigating use-related risks specific to AI devices.

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.14203189

Authors: Engler, Michael, Johner, Christian, Krepcke, Martin, Martinez Torres, Manuel Isaac, Stangenberg, Martin

Institutions: Johner Institut (Germany), Siemens Healthineers (Germany), Philips (Netherlands), Stryker (Germany)

Language: English

Topic: Artificial Intelligence in Healthcare and Education

Subfield: Health Informatics

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W6949015208

FWCI: 0.08

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Cited by: 1

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