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THE MEDICAL DIRECTIVE 93/42/EEC CURRENT SPECIFICATIONS AND PROPOSED CHANGES

This section specifically identifies the required EMC tests, and lists recommended test equipment to conduct the tests.   The harmonized medical EMC standard that is used to demonstrate EMC compliance is EN60601-1-2.  Call us for more details.... 

The harmonized medical EMC basic standard EN60601-1-2:    The following basic standard/equipment matrix is offered for planning purposes.

Electrostatic Discharge IEC61000-4-2 

6kV Contact Discharge

8kV Air Discharge

ESD 30 Electrostatic Discharge Generator P18 discharge probe, AD air discharge module, RSI/IEC contact discharge module, PRT wooden table with built in horizontal coupling plane, EAS 30 grounding cable for the horizontal coupling plane, VCP vertical coupling plane with grounding cable, KW2 optional target for calibrating of ESD 30
Radiated RF Electromagnetic Fields IEC61000-4-3 

For non-life supporting equipment: 3V/m with 80% AM, from 80Mhz to 2.5Ghz

For life support equipment, 3V/m with 80% AM from 80Mhz to 800Mhz, 10V/m with 80% AM, from 800Mhz to 2Ghz

AT1080 and AT4002A antennas, 10W1000C and 1S1G4  RF power amplifiers for non-life supporting equipment, 30W1000B and 5S1G4  RF power amplifiers for life supporting equipment, DC6080 & DC7140 dual directional couplers, FM5004/FP5000 isotropic field monitor system, SW1004 software
Alternative:  ARCell, with optional FP4000 field probe ( See ARCell information for power amplifier selection.)
Burst IEC61000-4-4

+/-2kV on AC or DC power lines and +/-1kV on signal and interconnecting cables greater than 3 meters

UCS500M/2 Ultra compact simulator HFK capacitive coupling network, WIN COM complete reporting software, KW50 optional 50-ohm matching resistor with 100:1 divider for viewing waveforms.
Surge IEC61000-4-5

1kV in differential mode (line to line)

2kV in common mode (line to ground)

UCS500M/2 Ultra compact simulator WIN COM complete reporting software, CNV 504 or CNV 508 coupling network for data lines
Conducted Disturbances Induced by RF Fields IEC61000-4-6

3 V/m with 80% AM, 150kHz to 80Mhz

 

CWS-500 RF Immunity Generator with ATT 6/75 and appropriate CDN's  Optional WIN ICD software
Power Frequency Magnetic Fields IEC61000-4-8

5A/m, 50Hz and 60Hz

UCS-500M/2 Ultra Compact Simulator, MV2616 motorized variac, MC2630 current transformer, MS-100 magnetic field coil.
Voltage Dips, Short Interruptions, and Voltage variations on power supply input lines IEC61000-4-11

100% dip for 0.5 cycle
60% dip for 5 cycles
30% dip for 25 cycles
Total interruption of power for 5 seconds

UCS-500M/2 Ultra Compact Simulator, V4070M1 auto transformer or MV2616 motorized variac.

For more information contact Frank Krozel.
Copyright 2002 Electronic Instrument Associates-Central, Inc.