New challenges in Edition 4.0
of the medical EMC standard
IEC 60601-1-2
Wilko de Graaf
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June 21st, 2016
IEC 60601-1-2 Edition 4.0: 2014
Prevent hazards
Medical electrical equipment –
Part 1-2:
General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances –
Not equal to
Requirements and tests
compatibility
Part of IEC 60601
group
2
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IEC 60601-1-2 Edition 4.0: 2014
Emission: CISPR 11 (unchanged)
Immunity:
• BASIC SAFETY = freedom from unacceptable
•
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RISK directly caused by physical HAZARDS
when ME EQUIPMENT is used under NORMAL
CONDITION and SINGLE FAULT CONDITION
ESSENTIAL PERFORMANCE = performance of
a clinical function, other than that related to
BASIC SAFETY, where loss or degradation
beyond the limits specified by the
MANUFACTURER results in an unacceptable
RISK
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Environments of INTENDED USE
e.g. hospitals, clinics,
birthing centers,
dental offices, etc.
e.g. residences, shops,
cars, hotels, museums,
etc.
e.g. nearby HF SURGICAL EQUIPMENT,
inside shielded room of MRI,
military areas,
heavy industrial areas, etc.
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Risk management in IEC 60601-1-2 ed. 4
• Determine INTENDED USE.
• Risk analysis: what HAZARD could possibly happen due to EMI,
in the intended EM Environment?
• Risk evaluation: what is acceptable, and what is not?
• Risk reduction: robust concept, fail-safe, instruction.
• Derive performance criteria.
• Determine location of intended use.
• Derive applicable test levels.
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Risk management in IEC 60601
• Perform immunity tests
• at applicable test levels.
• Verify whether performance criteria are met.
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Immunity test levels:
subject to change by risk management
ESD
• ±8 kV contact discharge
• ±2 kV, ±4 kV, ±8 kV, ±15 kV air discharge
• Including connectors that can be touched by standard test finger
Electrical Fast Transients / Bursts
• ±2 kV a.c./d.c. power ports
• ±1 kV signal input/output ports
• Repetition frequency: 100 kHz
Surges
• ±0.5 kV, ±1 kV line-to-line
• ±0.5 kV, ±1 kV, ±2 kV line-to-ground
• At four phase angles
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Immunity test levels:
subject to change by risk management
Power Frequency Magnetic Fields
• 30 A/m
• Only for products with magnetically sensitive components
Voltage Dips and Interruptions
• 0%, 0.5 cycle, at eight phase angles
• 0%, 1 cycle at 0°
• 70%, 0.5 second
• 0%, 5 seconds
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Immunity test levels:
subject to change by risk management
Conducted Immunity
• 3 V, 0.15-80 MHz
• 6 V at ISM bands (professional healthcare facility environment)
• 6 V at ISM and amateur radio bands (HOME HEALTHCARE ENVIRONMENT)
Radiated Immunity
• 3 V/m, 80-2700 MHz (professional healthcare facility environment)
• 10 V/m, 80-2700 MHz (HOME HEALTHCARE ENVIRONMENT)
• Including intentional receiving frequency
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Immunity test levels:
subject to change by risk management
• Proximity fields from RF wireless communications equipment
Service
TETRA 400
Test frequency
385 MHz
Amplitude Modulation
27 V/m
PM, 18 Hz
GMRS 460, FRS
460
LTE band 13, 17
450 MHz
28 V/m
710, 745, 780 MHz
9 V/m
FM ± 5 kHz
dev., 1 kHz sine
PM, 217 Hz
810, 870, 930 MHz
28 V/m
PM, 18 Hz
1720, 1845, 1970,
2450 MHz
28 V/m
PM, 217 Hz
5240, 5500, 5785
MHz
9 V/m
PM, 217 Hz
GSM, TETRA,
CDMA, etc.
GSM, DECT,
UMTS, Bluetooth,
WLAN, etc.
WLAN 802.11
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Immunity test
• Proximity fields from RF wireless communications equipment
tested according
IEC 61000-4-3
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Documentation
• New requirements for test plan
• New requirements for test report
• Requirements for product documentation renewed
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Transition period edition 3 to edition 4
Publication of IEC 60601-1-2 edition 4:
• 2014-02
EU:
• Dow 2018-12-31 (all products on the market)
USA:
• 2017-04-01 (new products on the market)
Other parts of the world:
• May differ per country
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