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EMC For Medical Devices-Basics 1
EMC For Medical Devices-Basics 1
What’s new in the 4th edition? In addition to these increased In the European Union, all devices
In the 4th edition the requirements immunity test levels, the risk including legacy devices placed on
are based on three intended use management section has been the market must comply with the
environments of the equipment, expanded. Risk management of new 4th edition standard after this
instead of the purpose of the electromagnetic disturbances date. For other regions it varies with
equipment: professional healthcare (including reliable wireless the local regulations of the country.
facility (eg: hospital, physician connections) has become a
offices), home healthcare (eg: homes, mandatory compliance requirement What about EMC performance?
nursing home, public places), and over the operational lifetime of a IEC 60601-1-2:2014 is a safety
special environment (military areas, medical device. All risk information standard. The test levels for basic
heavy industrial areas, high power (analysis, evaluation, control, safety and essential performance
medical equipment …). customer complaints, revised are based on reasonably
standards, market surveillance foreseeable maximum levels of EM
Overleaf is a summary of the main reports, etc.) has to be maintained disturbances. A technical report
differences in immunity test levels in the risk management file. IEC TR 60601-4-2:2016 has been
between edition 3 (2007) and Compliance is checked by inspection issued to provide guidance on
edition 4 (2014). of the test report and the risk assessing immunity, with regard
management file. to EMC performance (intended
Edition 4 has more stringent immunity use). The immunity test levels for
requirements for electrostatic When do you have to comply with EMC performance are based on
discharges, magnetic fields, proximity the 4th edition? typical levels of EM disturbances.
fields from wireless transmitters. The 4th edition of the medical EM This technical report can be used
Proximity fields from RF wireless standard IEC 60601-1-2:2014 will in conjunction with IEC 60601-1-2
communication equipment is a new become mandatory in the United and testing for conformity to both
test that is based on a minimum States and the European Union from documents can be done at the same
separation distance of 30 cm between December 31st 2018 onwards. The time.
the wireless communication transmitter FDA does not require retesting of
and the medical device. This test is now legacy products unless changes are
included because mobile device usage made to the product that may affect
restrictions are generally ignored. its compliance.
Comparison of immunity test levels IEC 60601-1-2: edition 3 versus 4
Surges
IEC 61000-4-5
AC mains, Line to Ground ±0.5, 1, 2 kV ±0.5, 1, 2 kV
AC mains, Line to Line ±0.5, 1 kV ±0.5, 1 kV
DC input (>3m) L to G No test ±0.5, 1, 2 kV
DC input (>3m) L to L No test ±0.5, 1 kV
I/O Line to Ground No test ±2 kV (outdoor lines only)
Mains voltage dips and interruptions >95% dip, 0.5 periods, 0° and 180° 100% dip, 0.5 periods, 0°, 45°, 90°, 135°,
IEC 61000-4-11 60% dip, 5 periods 180°, 225°, 270°, 315°
30% dip, 25 periods 100% dip, 1 period
30% dip, 25/30 periods (50/60 Hz)
Interrupt >95% drop, 5 sec
Interrupt 100% drop, 5 sec