Electrical Safety Testing of Medical Equipment in Japan

Ezawa, Masashi

doi:10.1097/00004669-199001000-00008

Journal of Clinical Engineering

1990

DOI: 10.1097/00004669-199001000-00008

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Electrical Safety Testing of Medical Equipment in Japan

Masashi Ezawa

Abstract: In Japan, the manufacture and sale of medical electrical equipment requires the permission and license of the Ministry of Health and Welfare. Electrical safety tests must be conducted at an official institution. This paper presents the statistical results of a series of 404 safety tests of medical devices, reports the electrical safety problems encountered, and suggests electrical design considerations for safety.

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New ac microammeter for leakage current measurement of biomedical equipment

Branca

Prete

Marinozzi

1993

Review of Scientific Instruments

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A new inexpensive current probe for on-line leakage current measurement of biomedical devices in hospital environment is described. The prototype is designed to detect and measure leakage currents on the ground wire of the device’s power cord so that its integrity can be monitored in real time. Realized with a sensing coil specially matched to a low-noise op amp, this probe adds only negligible impedance on the monitored ground lines. From this preliminary study about the device’s metrological performances, a sensitivity of 10 nArms for a current range 1–500 μArms has emerged, together with a mean linearity error of 0.03% and a frequency response flat within 1% of gain from 50 to 2000 Hz.

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New ac microammeter for leakage current measurement of biomedical equipment

Branca

Prete

Marinozzi

1993

Review of Scientific Instruments

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The “Leakage Current Sentinel”: A novel plug-in socket device for online biomedical equipment electrical safety surveillance

Cappa

Marinozzi

Sciuto

2000

Review of Scientific Instruments

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The Leakage Current Sentinel (LCS) has been designed and implemented for the detection of hazardous situations caused by dangerous earth leakage current values in intensive care units and operating theaters. The device, designed and manufactured with full compliance of the high risk environment requirements, is able to monitor online the earth leakage current and detect ground wire faults. Operation utilizes a microammeter with an overall sensitivity of 2.5×104 V/A. In order to assure the reliability of the device in providing alarm signals, the simultaneous presence of absorbed power current is monitored by means of another ammeter with decreased sensitivity (3.0 V/A). The measured root mean square current values are compared with reference values in order to send signals to NAND and OR complementary metal–oxide–semiconductor gates to enable audible and visible alarms according to the possible hazardous cases examined in the article. The final LCS packaging was shaped as a wall socket adapter for common electromedical device power cord plugs, with particular attention to minimizing its dimensions and to provide analog voltage outputs for both measured leakage and power currents, in order to allow automatic data acquisition and computerized hazardous situation management. Finally, a personal computer based automatic measuring system has been configured to simultaneously monitor several LCSs installed in the same intensive care unit room and, as a consequence, to distinguish different hazardous scenarios and provide an adequate alert to the clinical personnel whose final decision is still required. The test results confirm the effectiveness and reliability of the LCS in giving an alert in case of leakage current anomalous values, either in case of a ground fault or in case of a dangerous leakage current.

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Electrical Safety Testing of Medical Equipment in Japan

Cited by 2 publications

References 0 publications

New ac microammeter for leakage current measurement of biomedical equipment

New ac microammeter for leakage current measurement of biomedical equipment

The “Leakage Current Sentinel”: A novel plug-in socket device for online biomedical equipment electrical safety surveillance

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