Metrological Reliability of Medical Devices

2014 Joint IMEKO TC1-TC7-TC13 Symposium: Measurement Science Behind Safety and Security

Costa Monteiro, E.^1 ; Leon, L.F.^1

Postgraduate Program in Metrology, Pontifical Catholic University of Rio de Janeiro, Brazil^1

关键词: Biomeasurements;    Biomedical applications;    Chemical and biologicals;    Clinical measurements;    Health technology;    Medical Devices;    Metrological reliability;    Physiological measurement;   

Others  :  https://iopscience.iop.org/article/10.1088/1742-6596/588/1/012032/pdf
DOI  :  10.1088/1742-6596/588/1/012032

来源: IOP

【 摘 要 】

The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.