Rule 4.3 Description 4.3(2)(a) Examples: magnetic resonance equipment, pulp testers, evoked response stimulators, diagnostic A device to supply energy that will be absorbed by a ultrasound. patient’s body (except a device that illuminates the patient’s body in the visible spectrum)—Class IIa. 4.3(2)(b) Examples: gamma cameras, positron emission tomography, single photon emission computer A device to be used to image in vivo distribution of tomography. radiopharmaceuticals in patients—Class IIa. 4.3(2)(c) Examples: electrocardiographs, electroencephalographs, cardioscopes with or without A device used for direct diagnosis or monitoring of pacing pulse indicators, electronic thermometers. vital physiological processes of a patient, excluding devices mentioned in the previous entry—Class IIa. 4.3(3)(a) Examples: intensive care monitoring systems, biological sensors, blood gas analysers used in A device to monitor vital physiological parameters of a surgery, cardioscopes and apnea monitors patient, and the nature of variations monitored could including those in home care. result in immediate danger to the patient—Class IIb. Please note: For this clause monitored’, is ‘variations taken to mean that the result of monitoring could lead to immediate danger to the patient. This is typically, but not always, accompanied by an alarm. 4.3(3)(b) Examples: diagnostic x-ray sources, linear accelerators. A device to emit ionising radiation and to be used for diagnostic or therapeutic interventional IIb. 4.3(3)(c) Examples: auto exposure control systems, radiotherapy after controls systems. A device to control, monitor or directly influence the performance of a device in the previous entry—Class IIb. Rule 4.4 Active medical devices intended to administer or remove medicines, etc from a patient’s body This rule covers drug delivery systems and anaesthesia equipment. Rule 4.4 Description 4.4(1) Examples: suction equipment, feeding pumps, jet injectors for vaccination. An active device to administer or remove medicine, body liquids or other substances—Class IIa.
Rule 4.3 Description 4.3(2)(a) A device to supply energy that will be absorbed by a patient’s body (except a device that illuminates the patient’s body in the visible spectrum)—Class IIa. Examples: magnetic resonance equipment, pulp testers, evoked response stimulators, diagnostic ultrasound. 4.3(2)(b) A device to be used to image in vivo distribution of radiopharmaceuticals in patients—Class IIa. Examples: gamma cameras, positron emission tomography, single photon emission computer tomography. 4.3(2)(c) A device used for direct diagnosis or monitoring of vital physiological processes of a patient, excluding devices mentioned in the previous entry—Class IIa. Examples: electrocardiographs, electroencephalographs, cardioscopes with or without pacing pulse indicators, electronic thermometers. 4.3(3)(a) A device to monitor vital physiological parameters of a patient, and the nature of variations monitored could result in immediate danger to the patient—Class IIb. Please note: For this clause ‘variations monitored’, is taken to mean that the result of monitoring could lead to immediate danger to the patient. This is typically, but not always, accompanied by an alarm. Examples: intensive care monitoring systems, biological sensors, blood gas analysers used in surgery, cardioscopes and apnea monitors including those in home care. 4.3(3)(b) A device to emit ionising radiation and to be used for diagnostic or therapeutic interventional IIb. Examples: diagnostic x-ray sources, linear accelerators. 4.3(3)(c) A device to control, monitor or directly influence the performance of a device in the previous entry—Class IIb. Examples: auto exposure control systems, radiotherapy after controls systems. Rule 4.4 Active medical devices intended to administer or remove medicines, etc from a patient’s body This rule covers drug delivery systems and anaesthesia equipment. Rule 4.4 Description 4.4(1) An active device to administer or remove medicine, body liquids or other substances—Class IIa. Examples: suction equipment, feeding pumps, jet injectors for vaccination.
devices-argmd-p1-01.docx