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Neumüller / EMV / Medizintechnik

Was ändert sich mit der neuen Medizin-/EMV-Norm?

2. Februar 2017, 16:24 Uhr | Nicole Wörner

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Fortsetzung des Artikels von Teil 1

Was sind die konkreten Anforderungen?

Port	Basic Standard for Test Method	EN 60601-1-2:2007	IEC 60601-1-2: 2014
Port	Basic Standard for Test Method	EN 60601-1-2:2007	Professional Healthcare Facility Environment	Home Healthcare Environment
Enclosure Port	IEC 61000-4-2	6 kV (Contact discharge) 8 kV (Air discharge)	8 kV (Contact discharge) 15 kV (Air discharge)	8 kV (Contact discharge) 15 kV (Air discharge)
	IEC 61000-4-3	80 to 2500 MHz / 10 V/m for LIFE-SUPPORTING	80 to 2700 MHz / 3 V/m	80 to 2700 MHz / 10 V/m
	IEC 61000-4-3	80 to 2500 MHz / 3 V/m for not LIFE-SUPPORTING	Frequency: up to 5785MHz Level: up to 28V/m	Frequency: up to 5785MHz Level: up to 28V/m
	IEC 61000-4-8	50 or 60 Hz 3 A/m	50 or 60 Hz 30 A/m	50 or 60 Hz 30 A/m
AC input power port	IEC 61000-4-4	2 kV	2 kV / 100kHz	2 kV / 100kHz
	IEC 61000-4-5	1 kV line to line 2 kV line to earth	1 kV line to line 2 kV line to earth	1 kV line to line 2 kV line to earth
	IEC 61000-4-6	0.15 to 80 MHz / 10 V for LIFE-SUPPORTING	0.15 to 80 MHz / 3 V	0.15 to 80 MHz / 3 V
	IEC 61000-4-6	0.15 to 80 MHz / 3 V for not LIFE-SUPPORTING	6 V in ISM bands	6V in ISM bands & amateur radio bands
	IEC 61000-4-11	<5 % UT for 0,5 cycle	<5 % UT for 0,5 cycle	<0 % UT for 0,5 cycle
		<5 % UT for 0,5 cycle	at step: 45°	at step: 45°
		40 % UT for 5 cycles	0 % UT for 1 cycle	0 % UT for 1 cycle
		70 % UT for 25 cycles	70 % UT for 25/30 cycles	70 % UT for 25/30 cycles
		<5 % UT for 5 s	<5 % UT for 250/300 cycles	<5 % UT for 250/300 cycles
DC input power port	IEC 61000-4-4	2 kV	2 kV / 100kHz	2 kV / 100kHz
	IEC 61000-4-5	N/A	1 kV line to line 2 kV line to earth	1 kV line to line 2 kV line to earth
	IEC 61000-4-6	0.15 to 80 MHz / 10 V for LIFE-SUPPORTING	0.15 80 MHz / 3 V	0.15 to 80 MHz / 3 V
	IEC 61000-4-6	0.15 to 80 MHz / 3 V for not LIFE-SUPPORTING	6V in ISM bands	6V in ISM bands & amateur radio bands
	ISO 7637-2	N/A	N/A	ISO 7637-2:2011
Signal input/output parts port	IEC 61000-4-4	1 kV / 5KHz	1 kV / 100kHz	1 kV / 100 kHz
	IEC 61000-4-5	N/A	2kV line to earth for outdoor	2kV line to earth for outdoor
	IEC 61000-4-6	0.15 to 80 MHz / 10 V for LIFE-SUPPORTING	0.15 to 80 MHz / 3 V	0.15 to 80 MHz / 3 V
	IEC 61000-4-6	0.15 to 80 MHz / 3 V for not LIFE-SUPPORTING	6V in ISM bands	6V in ISM bands & amateur
Patient coupling port	IEC 61000-4-2	N/A	8 kV (Contact discharge) 15 kV (Air discharge)	8 kV (Contact discharge) 15 kV (Air discharge)
	IEC 61000-4-6	N/A	0.15 to 80 MHz / 3 V	0.15 to 80 MHz / 3 V
	IEC 61000-4-6	N/A	6V in ISM bands	6V in ISM bands & amateur radio bands