Medical electrical equipment : General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

A new version of the medical EMC standard IEC60601-1-2 was published in 2014, widely referred to as the 4th Edition.

There are two main aims of the revisions.  One is to improve immunity of equipment partly due to the proliferation of wireless communication devices operating within the local proximity of what may essentially be life critical equipment.  These wireless devices may take the form of mobile phones, blue-tooth, WiFi, Tetra, RFID or paging system products.

The second aim is to introduce an element of risk analysis into deciding which levels of immunity are suitable for the equipment, its intended operating environment and foreseeable levels of disturbances.  This is due to the inclusion into the standard of equipment intended to operate outside of hospital environments in which there is less supervision of equipment and less control over the electro-magnetic phenomena present.  Part of the risk approach is that manufacturers must be clear about the essential operation of their product and mitigate the risk of failure or abnormal or unexpected operation by choosing the appropriate immunity levels which may be higher than indicated in the following table.

The 4th Edition considers three environments: professional health care facility, home health care and special environments, examples of which could include heavy industry or medical equipment intentionally generating high power fields.  As the required immunity levels now relate to these environments rather than to the product, the term ‘life supporting equipment’ is no longer used.

In the US, the FDA will require declarations to be made to the new standard from 1st April, 2017.  In Europe, the current 3rd Edition standard EN60601-1-2:2007 will be withdrawn on 31st December, 2018 and replaced by EN60601-1-2:2015.  The standard covers emissions and immunity but the emission limits are unchanged.  The changes to immunity over the 3rd edition are given in the following table:

  Test 3rd Edition 4th Edition
Electrostatic Discharge
EN61000-4-2

Contact discharge

Air discharge

+/-2, 4, 6 kV

+/-2, 4, 8 kV

+/-2, 4, 8 kV

+/-2, 4, 8, 15 kV

Radiated RF Immunity
EN61000-4-3
Enclosure 3V/m, life support 10V/m. 80% AM at 1kHz or 2Hz, 80MHz to 2500MHz 3V/m, Home healthcare 10V/m. 80% AM at 1kHz or risk frequency, 80MHz to 2700MHz
Electrical fast transients & Bursts
EN61000-4-4

AC mains or DC input

I/O Ports

+/-2kV, 5kHz
Pulse Repetition Frequency

+/-1kV, 5kHz
Pulse Repetition Frequency

+/-2kV, 100kHz
Pulse Repetition Frequency

+/-1kV, 100kHz
Pulse Repetition Frequency

Surges
EN61000-4-5

AC mains, line to ground

AC mains, line to line

DC input (>3m), line to ground

DC input (>3m), line to line

I/O, line to ground

+/-0.5, 1, 2kV at zero crossing

+/-0.5, 1kV at zero crossing

No test

No test

No test

+/-0.5, 1, 2kV at 0, 90, 180, 270o

+/-0.5, 1kV at 0, 90, 180, 270o

+/-0.5, 1, 2kV at 0, 90, 180, 270o

+/-0.5, 1kV at 0, 90, 180, 270o

+/-2kV on outdoor lines only

Conducted RF Immunity
EN61000-4-6

AC mains

DC and I/O and patient coupled (>3m)

3V, life support 10V Industrial, Scientific, Medical. 80% AM at 1kHz or 2Hz, 150kHz to 80MHz

3V, life support 10V Industrial, Scientific, Medical. 80% AM at 1kHz or 2Hz, 150kHz to 80MHz

3V with 6V Industrial, Scientific, Medical, Home healthcare 6V. 80% AM at 1kHz or risk frequency, 150kHz to 80MHz

3V with 6V Industrial, Scientific, Medical, Home healthcare 6V. 80% AM at 1kHz or risk frequency, 150kHz to 80MHz

Power frequency magnetic fields
EN61000-4-8
Enclosure 30A/m, 50 and 60Hz 100% dip, 0.5 cycle at 0, 45, 90, 135, 180, 225, 270 and 315o
Voltage dips and interruptions
EN61000-4-11

Dips

 Interruptions

>95% dip, 0.5 cycle, 0 and 180o

60% dip, 5 cycles

30% dip, 25 cycles

>95% Interrupt, 5 seconds

100% dip, 0.5 cycle at 0, 45, 90, 135, 180, 225, 270 and 315o

100% dip, 1 cycle

30% dip, 25/30 cycles

100% Interrupt, 5 seconds

There is also the additional requirement to show immunity to radiated noise emanating from wireless devices:

 

Service

Test frequency

Band

Pulse Modulation

Test level

Radiated proximity field
EN61000-4-3

Tetra 400

385MHz

380-390MHz

18Hz

27V/m

GMRS460, FRS460

450MHz

430-470MHz

1kHz

28V/m

LTE Band 13, 17

710, 745, 780MHz

704-77MHz

217Hz

9V/m

GSM800/900, Tetra800, IDEN820, CDMA850, LTE Band 5

810, 870, 930MHz

800-960MHz

18Hz

28V/m

GSM1800, CDMA1900, GSM1900, DECT, LTE Band 1, 3, 4, 25, UMTS

1720, 1845, 1970MHz

1700-1990MHz

217Hz

28V/m

Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Bamd 7

2450MHz

2400-2570MHz

217Hz

28V/m

WLAN 802.11 a/n

5240, 5500, 5785MHz

5100-5800MHz

217Hz

9V/m

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