IEC 60601-1-2 4th Edition

EMC for Medical Electrical Equipment

The IEC 60601-1-2 4th Edition was realized in February, 2014. The new international standard replaces the IEC 60601-1-2 3rd Edition from 2007.
The standard covers test procedures and requirements for the electromagnetic compatibility of medical electrical equipment.

USA

The Food and Drug Administration (FDA) of the United States recommends in its design guidelines to consider the using of the 4th Edition of the ANSI/AAM/IEC 60601-2: 2014-02. The end date of the transition period was often delayed. At the beginning it was the 1st of August 2016*, then the date was changed to the 1st of April 2017** and since August 2016 the transition period ends 2018-12-31***. Within this date the FDA accept only declarations of conformity to the 4th Edition every device has to fulfill this standard.
[…]“FDA recommends that you consider using the FDA-recognized ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02 standard […] If you use ANSI/AAMI/IEC 60601-1-2 Edition 3:2007 during the transition period to Edition 4 that ends December 31, 2018, you should be aware that electromagnetic disturbance in the home healthcare environment can exceed the default test levels for the hospital environment that are specified in Edition 3.“[…]***

Germany / Europe

The DIN EN60601-1-2 was published in May 2016 as EN60601-1-2:2015 and replaces the DIN EN 60601-1-2: 2007-12 + Corrections 1:2010-05.
The beginning of conformity date was the 1st of May 2016, the transition period ends 2018-12-31. Within this date every device has to fulfill the 4th Edition.

What distinguishes the 4th Edition from the 3rd Edition?

The 4th edition of IEC standard takes special emphasis on risk analysis and assessment. The first step of the manufacturer must be specifying the essential performance and basic safety of the medical device. It could be that devices and accessories have no essential performance. The complete device or system must be considered and checked. The essential performance are worked out acc. ISO 14971 and IEC60601-1 and defined individually for each device. Hence the previous simple evaluation criteria are omitted. The manufacturer defines, if a function is an essential performance and if a malfunction could be tolerable.
A difference between life supporting and non-life supporting has not been importance, in contrast to the 3rd edition.

The second step will be the definition of INTENDED USE and INTENDED ENVIRONMENTS

  1. Professional Healthcare facility environment
  2. Home Healthcare environment
  3. Special environment

For the first two environments are emissions and immunity requirements specified. For the third environment the limit values must assessed be based on the risk analysis of the special environment, this can lead to very high requirements for immunity.

Requirements of ME Equipment’s in Professional Healthcare facility environment

Requirements of ME Equipment’s in Professional Healthcare facility environment

The major amendment is the improved withstands against electrostatic discharge (IEC 61004-2 ESD). The test levels are increased from 6kV to 8kV contact discharge and form 8kV to 15kV air discharge.
Further, the frequency range of immunity against radiated emissions (IEC61000-4-3) is increased from 2.5GHz to 2.7 GHz. The immunity level is 3V/m.
Complete new are tests of RF EM fields and Proximity fields in frequency bands (385MHz – 5,7GHz) the field intensity is up to 28V/m. The behavior of ME Equipment influenced by RF EM fields from wireless communications will be simulated by these tests.

IEC 61000-4-3 Immunity level

The requirements of magnetic fields (IEC61000-4-8) was changed, the test level is increased ten times from 3A/m to 30A/m.
The repetition frequency for Burst pulses (IEC61000-4-4 Burst) is changed from 5kHz to 100kHz, this comes closer to the real world value of such an EM phenomenon.

The requirements of conducted RF induced by RF fields (IEC 61000-4-6) are slightly changed. The test level is now 3V in a Frequency range of 150kHz -80MHz and 6V in the ISM bands. The test level of 10V for life supporting devices has no longer been necessary.

There are small changes for Voltage dips, short interruptions and voltage variations on power supply input lines (IEC 61000-4-11), among others the voltage drop to 40% UT is deleted.

Requirements for ME Equipment in home healthcare environment

Medical devices in home healthcare environment must fulfill at least the same, in some point’s even higher, values than in professional Healthcare facility environment. This is caused in the higher pollution by unknown transmission power in different frequency bands (radio, TV, amateur radio, Bluetooth, WLAN, GSM, UMTS, LTE etc.)

The following EM phenomenon’s have higher requirements,

  • Radiated RF EM fields (IEC61000-4-3) 30MHz-2,7 GHz increased immunity level of  10V/m
  • For conducted RF induced by RF fields (IEC 61000-4-6) 150kHz – 80MHz is the 6V immunity level, even valid for amateur radio frequency bands, not only for ISM frequency bands.

IEC 61000-4-6 Immunity level

4th Edition Challenge for power supply and ME device

With this standard, the risk assessment is given a whole new significance. Manufacturers of medical devices and systems must work more closely with the manufacturers of the power supplies and other accessories, because a risk assessment may vary on the intended use and other external conditions.

4th Edition and 3rd Edition overview

 

3rd Edition

4th Edition

CISPR 11 Emissions

Class A*** or  B

Class A*** or B

IEC 61000-3-2 Harmonics

Class A

Class A

IEC 61000-3-3 Voltage Fluctuation

PASS

PASS

IEC 61004-2 ESD

6kV contact discharge

8kV air discharge

8kV contact discharge

15kV air discharge

IEC61000-4-3 Radiated disturbance

30MHz – 2,5GHz 3* or 10** V/m

30MHz – 2,7GHz 3* or 10V/m**

IEC61000-4-3

Nearfield disturbance of wireless communication

No requirements

385MHz – 5,7GHz 9-28V/m

IEC61000-4-4 Burst

+/-2kV Repetition frequency  5kHz

+/-2kV Repetition frequency    100kHz

IEC61000-4-5 Surges

1kV Line to Line

2kV Line to GND

1kV Line to Line

2kV Line to GND

IEC61000-4-8 Magnetic Field

3A

30A

IEC 61000-4-6  Conducted disturbance

150kHz – 80MHz 3* or 10** V

150kHz – 80MHz 3 or 6V ISM* and amateur radio frequency**

IEC 61000-4-11 Voltage Dips

<5% UT 0,5/1 Cycle

40% UT 5 Cycle

70% UT 25/30 Cycle

<5% >UT 5s

0% UT 0,5 different angles

0% 1 Cycle

70% UT 25/30 Cycle

0% >UT 5s

 

*life supporting

**non-life supporting

*** Hospital

* Professional Healthcare Facility Environment

** Home Healthcare Environment

*** Hospital



*
http://industries.ul.com/blog/fda-adds-4th-edition-iec-60601-1-2-list-emc-consensus-standards

**http://industries.ul.com/news/fda-extends-emc-standard-transition-date-to-april-1-2017

***http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM331681.pdf