Le présent document spécifie les exigences métrologiques et techniques des thermomètres médicaux auriculaires avec dispositif à maximum pour une détermination intermittente de la température du corps humain. Il s'applique aux dispositifs qui, lors du mesurage des températures, sont alimentés par une source d'énergie soit interne soit sur secteur, et qui fournissent une indication de la température du corps humain en mesurant le rayonnement thermique de tout ou partie du conduit auditif. Les dispositifs conçus pour mesurer exclusivement la température de la membrane tympanique sont également couverts par le présent document.
ISO 80601-2-56:2009 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, referred to as ME equipment. ISO 80601-2-56:2009 specifies the general and technical requirements for electrical clinical thermometers. ISO 80601-2-56:2009 applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME systems. ISO 80601-2-56:2009 does not apply to auxiliary equipment. ME equipment that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of ISO 80601-2-56:2009. Requirements for ME equipment intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601‑2‑59:2008 and such ME equipment is not covered by ISO 80601-2-56:2009.
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