Utilisabilité des dispositifs médicaux : diagnostic des difficultés de compréhension et d'application de la norme IEC 62366

Abstract : To ensure patient and users’ health and safety while using Medical Devices (MD), European Union introduced “ergonomics” as an essential requirement for the CE marking of MD. To comply with this requirement, the IEC 62366:2007 standard has been published to guide the implementation of the Usability Engineering Process (UEP) into the medical device design and development cycle. However, ergonomics standards are known to be difficult to apply to design and evaluate systems (devices, interactive systems, etc.). Thus, the main objective of this work is to identify difficulties in understanding and applying the IEC 62366 standard so as to provide better user guidance. Based on a triangulation of methods, this research identifies difficulties in understanding and applying the IEC 62366 standard, difficulties which could lead to an underestimation of risks of use errors of MD. The main results of this thesis are that: (i) The IEC 62366 standard required a pluridisciplinary expertise to be correctly mastered, (ii) The way the IEC 62366 standard has been designed (presentation, structure and content) is impeding its understanding and the achievement of its objectives. The results of this research allow providing guidelines and research opportunities which should ensure an appropriate support to the proper application of the IEC 62366 standard requirements by his users. This thesis represents real translational research issue and offers long-term possibilities to the Human Factors community, MD manufacturers and MD certification bodies to overcome difficulties in applying the IEC 62366 standard, in improving the reliability and the quality of MD and above all in avoiding incident related to use errors
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Submitted on : Friday, March 30, 2018 - 9:50:13 AM
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  • HAL Id : tel-01754465, version 1

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Sabrina Bras da Costa. Utilisabilité des dispositifs médicaux : diagnostic des difficultés de compréhension et d'application de la norme IEC 62366. Médecine humaine et pathologie. Université de Lorraine, 2015. Français. ⟨NNT : 2015LORR0084⟩. ⟨tel-01754465⟩

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