Electrical and/or magnetic and electromagnetic energy - Muscle stimulators and external bone growth stimulators, TENS devices and eye electromagnets, electrical acupuncture |
Thermal energy - Cryosurgery equipment, heat exchangers, except the types described below |
Mechanical energy - Powered dermatomes, powered drills and dental hand pieces |
Light - Phototherapy for skin treatment and for neonatal care |
Sound - Hearing aids |
Ultrasound - Equipment for physiotherapy |
Note 1: The decision as to whether a medical device administers or exchanges energy to and from the human body in a potentially hazardous way should take into account the following factors. The concept of "potentially hazardous" is dependent on the type of technology involved and the intended application of the device to the patient and not on the measures adopted by the manufacturer in view of goos design management (e.g. use of technical standards, risk analysis). For instance all devices intended to emit ionizing radiation, all lung ventilators and lithotriptors should be in Class IIB. However, the manufacturer's obligation to comply with design requirements and solutions adopted, such as use of standards, exist independently from the classification system. |
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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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