CE for Medical Equipment

Medical Equipment Immunity and Emissions Test Tables

Applicable Standard

Description

Test or Measurement

Required by EN60601-1-2:2001

Required Criterion

Electrostatic Discharge

EN 61000-4-2

Direct and Indirect Air Discharge  ESD and Contact Discharge at several points  with 10 positive and 10 negative ‘hits’ per location.

Air Discharge

Contact Discharge

+/-8kV

+/-6kV

B

B

Radiated Immunity

EN 61000-4-3

Subject to electromagnetic field from 80 MHz to 2500 MHz.

Frequency Field Modulation (Non Life supporting Equipment)

Frequency Field Modulation (Life-supporting Equipment)

3V/m

 

10V/m

A

 

A

Electrical Fast Transient/Burst

EN 61000-4-4

EFT/Burst coupled to the all I/O and control signals, respectively is injected on the Power Line.

AC Line (Direct injection)

Signal Lines <3m (Cap. Clamp)

2.0kV

1.0kV

B

B

Surge Transient Susceptibility

EN 61000-4-5

5 Hits each of Surge Transients at  positive and negative pol. are injected on the Power Line. For AC; L1-L2, L1-PE, L2-PE, and at  0, 90 and 270 phase deg

AC Line to Earth

AC Line to Line

2.0kV

1.0kV

B

B

Conducted Immunity

EN 61000-4-6

Radio energy is coupled through I/O and control signals at 0.15 to 80 MHz

Power, Signal lines      Frequency  field Modulation (outside the ISM bands)

Inside the ISM Bands

3 V/m

 

10 V/m

A

 

A

Power Frequency Magnetic Field           EN 61000-4-8

Magnetic Susceptible apparatus is subject to a Magnetic field of 50 or 60 Hz

Hz

A/m

50 or 60 Hz

3 A/m

 

A

Voltage Dips

EN61000-4-11

Voltage on the power line is reduced

Voltage Dip

60% for 5 cycles

30% for 25 cycles

>95% for 0.5 cycles

B

B

C

Voltage Interruptions EN61000-4-11

Voltage on the power lines is interrupted

Voltage Interruption

>95% for 5 sec

C

 


Applicable Standard

Test Or Measurement

Required by

EN60601-1-2 :2001

Notes:

Conducted Emissions EN 55011

Phase And Neutral Power Lines

0.15 – 30.0 MHz

Class A or B Limits

Class A or B limits depending on there intended use as specified by the manufacturer

Radiated Emissions EN 55011

Horizontal And Vertical Polarization

30-1000 MHz

Class A or B Limits

Class A or B limits depending on there intended use as specified by the manufacturer

Harmonics Emission EN61000-3-2

Power Line

Maximum 1.08, 2.3, 0.43, 1.14, 0.3, 0.77, 0.23 A….. for 2nd to nth Harmonics to class D limits

Applicable for products rated under 16A

Voltage Flicker EN61000-3-3

Power Line

Maximum Voltage Flicker of   PST < 1, PLT < 0.65

Applicable for products rated under 16A