- | If they are intended to supply energy which will be absorbed by the human body, except for device used to illuminate the patient's body, in the visible spectrum:
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- | Magnetic resonance equipment, pulp testers, evoked response stimulators, diagnostic ultrasound |
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- | If they are intended to image in vivo distribution of radiopharmaceuticals: |
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- | Gamma cameras, positron emission tomography and single photon emission computer tomography |
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- | If they are intended to allow direct diagnosis or monitoring of vital physiological processes1: |
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- | Electrocardiographs, electroencephalographs, cardioscopes with or without pacing pulse indicators2 | |
- | Electronic thermometers |
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- | Electronic stethoscopes |
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- | Electronic blood pressure measuring equipment |
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Note 1: Vital physiological processes and parameters, include for example respiration, heart rate, cerebral functions, blood gases, blood pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological processes in anesthesia, intensive care or emergency care are in Class IIB, whilst medical devices intended to be used to obtain reading of vital physiological signals in routine check ups and in self-monitoring are in Class IIA. A thermal imaging device intended to monitor blood flow is not considered to be a temperature measuring device. Note 2: Devices specifically intended to monitor AIMDs fall under the AIMD Directive. |
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Esempi e precisazioni dalla MEDDEV 2.4/1
Qui termina il percorso per la classificazione del dispositivo di tuo interesse. Se vuoi ripercorrere il cammino fatto tra i dispositivi attivi premi qui; puoi anche tornare all'inizio o uscire. |
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