Framework
IECIEC 62366-1:2015+A1:2020
IEC 62366-1 specifies a process for manufacturers to analyze, specify, develop, and evaluate the usability of medical devices as it relates to safety. The standard provides a framework for applying usability engineering to optimize the user interface of medical devices, reducing use errors that could compromise patient safety or treatment effectiveness.
Overview
Background
Published by the International Electrotechnical Commission (IEC), this standard was developed to address the critical role that usability plays in medical device safety. It evolved from IEC 62366:2007 and was updated with Amendment 1 in 2020 to align with changes in risk management practices and to clarify the relationship between usability engineering and risk management processes.
Applicability
This standard applies to all medical devices that have a user interface or involve user interaction, regardless of whether the user is a healthcare professional, patient, or lay person. It is applicable throughout the device lifecycle, from initial concept through post-market surveillance, and is recognized by major regulatory bodies including the FDA and EU notified bodies.