Changes to the Medical Directive and the new test requirements
Comparison of IEC 60601-1-2 Ed3 & IEC 60601-1-2 Ed4 Emission & Immunity Test Requirements
EMISSION: CISPR 11 Class A, or Class B limits (Power Grid dependent)
IMMUNITY: Severity Levels defined upon the reasonable foreseeable maximum EM disturbance level, and upon the IEC/TR 61000-2-5:2011 EMC standard
The Edition 4:2014 addresses mainly 2 different – disturbance environments.
- Professional Healthcare
- Home Healthcare
EMISSIONS
| IEC 60601-1-2: Emissions Tests | Edition 3:2007 Requirements | Edition 4:2014 Requirements • Professional Healthcare • Home Healthcare |
| CISPR 11 Radiated Emissions | Class A (Industrial): /separated power lines: Large Hospital. Class B (Residential): /Non separated power lines: as offices. | Class A (Industrial): /separated power lines: Large Hospital. Class B (Residential): /Non separated power lines: as offices and Home Healthcare. |
| CISPR 11 Conducted Emissions | Class A (Industrial): /separated power lines: Large Hospital. Class B (Residential): /Non separated power lines: as offices. | Class A (Industrial): /separated power lines: Large Hospital. Class B (Residential): /Non separated power lines: as Home Healthcare. |
| IEC 61000-3-2 Harmonics emissions | Tested at 50 or 60Hz | Tested at 50 or 60Hz |
| IEC 61000-3-3 Flicker and Fluctuations | Tested at 50Hz | Tested at 50Hz |
IMMUNITY
| IEC 60601-1-2: Immunity Tests | Edition 3: 2007 Requirements | Edition 4: 2014 Requirements • Professional Healthcare • Home Healthcare |
| IEC 61000-4-2 Electrostatic Discharges | 6kV contact, 8kV air | 8kV contact, 15kV air (Stepped) |
| IEC61000-4-3 Radiated Immunity | 3V/m. 80-2500MHz, 1kHz/2Hz 80%AM modulation 10V/m. 80-2500MHz, 1kHz/2Hz 80%AM modulation for life support equipment Dwell Time is 3 seconds for 2Hz modulation Dwell Time is 1 second for 1kHz modulation | 3V/m, 80-2700MHz, 1kHz 80%AM modulation Professional Healthcare Facility Environment 10V/m, 80-2700MHz, 1kHz 80%AM modulation (Home Healthcare Environment Spot Frequencies – see chart) Modulation frequencies and dwell times defined by “Risk Assessment” and “test plan” |
| IEC 61000-4-4 Electrical Fast Transients / Burst | 2kV on AC and DC 5KHz Repetition 1kV on I/O | 2kV on AC and DC 100KHz Repetition 1kV on I/O 100KHz Repetition (patient coupling ports excluded) |
| IEC 61000-4-5 Power Surge | 2kV common mode. 1kV differential on AC lines (minimum 5 surges at each phase angle) | 500V,1kV & 2kV common mode, 500V & 1kV differential on AC & DC lines (>3m) 2KV common mode on I/O lines (Outdoor cables) |
| IEC 61000-4-6 Conducted Immunity | 3Vrms, 0.15-80 MHz, 1kHz/2Hz 80% AM modulation 3Vrms. 0,15-80 MHz, 1kHz/2Hz 80% AM modulation for life support equipment (Calibration required level set to 0-25% of target voltage) Patient coupled leads are tested with current clamp | 3Vrms, 0.15-80 MHz, 1kHz 80% AM modulation 3V at 0.15 – 80MHz & 6V at ISM Frequencies, Home Healthcare: 3V at 0.15 – 80MHz. and 6V at ISM & Radio Amateur Frequencies (I/O cables < 3m excluded) Patient coupled ports tested with current clamp. (See notes below) |
| IEC 61000-4-8 Magnetic Field | 50 and 60 Hz, 3A/m | 50 and 60 Hz. 30A/m |
| IEC 61000-4-11 Voltage Dips and Interruptions | Dip to 40% for 5 cycles (100 ms) Dip to 70% for 25 cycles (500ms) Dropout to 5% for 10 ms >95% for 5 sec | Dip to 0% for 1 cycles @ 0°phase angle Dip to 70% for 25/30 cycles @ 0° phase angle Dropout to 0% for 0.5 cycles @ 0°, 45°, 90°, 135°, 180°, 225°, 270° & 315° phase angles 100% for 250/300 cycles |
Testing to be completed at any one voltage and frequency…
IEC 60601-1-2:2014 (4th Edition) Immunity for Medical Electrical Equipment
Supplement Information for IEC 61000-4-3
Spot Frequency Table
Test | Band(MHz) (1) | Service (1) | Modulation (2) | Maximum Power | Distance (m) | Immunity |
385 | 380 –390 | TETRA 400 | Pulse (2) Modulation 18 Hz | 1.8 | 0.3 | 27 |
450 | 430 – 470 | GMRS 460, FRS 460 | FM (3) ±5 kHz deviation 1 kHz sine | 2.0 | 0.3 | 28 |
710 | 704 – 787 | LTE Band 13, 17 | Pulse (2) Modulation 217 Hz | 0.2 | 0.3 | 9 |
810 | 800 – 960 | GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 | Pulse (2) Modulation 18 Hz | 1.8 | 0.3 | 28 |
1 720 | 1 700 – 1 990 | GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS | Pulse (2) Modulation 217 Hz | 1.8 | 0.3 | 28 |
2 450 | 2 400 – 2 570 | Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 | Pulse (2) Modulation 217 Hz | 1.8 | 0.3 | 28 |
5 240 | 5 100 – 5 800 | WLAN 802.11 a/n | Pulse (2) Modulation 217 Hz | 0.2 | 0.3 | 9 |
NOTES :
If necessary to achieve the Immunity Test Level, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. | ||||||
The following summary of Spot Frequencies are required:
Pulse Modulation, 18Hz, 50% Duty Cycle
385MHz, (27V/m)
810MHz, 870MHz, 930MHz, (28V/m)
Pulse Modulation, 217Hz, 50% Duty Cycle
710MHz, 745MHz, 780MHz, (9V/m)
1720MHz, 1845MHz, 1979MHz, 2450MHz, (28V/m)
5240MHz, 5500MHz, 5785MHz, (9V/m)
Frequency Modulation, + 5 kHz Deviation 1kHz Sinewave
450MHz, (28V/m)
Additional Requirements for IEC 61000-4-6:
The ISM (industrial. scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765MHz to 6.795MHz; 13.553MHz to 13.567MHz; 26.957MHz to 27.283MHz; and 40.66MHz to 40.70MHz, The amateur radio bands between 0.15MHz and 80MHz are 1.8MHz to 2.0MHz, 3.5MHz to 4.0MHz, 5.3MHz to 5.4MHz, 7MHz to 7.3MHz, 10.1MHz to 10.15MHz, 14MHz to 14.2MHz, 18.07MHz to 18.17MHz, 21.0MHz to 21.4MHz, 24.89MHz to 24.99MHz, 28.0MHz to 29.7MHz and 50.0MHz to 54.0MHz.
Guidance Provided by: IEC/TR 61000-2-5:2011: Technical Report intended for guidance for developing immunity requirements and basic guidance for the selection of immunity levels.
Washington Laboratories has extensive experience in Medical Device Testing and Evaluation. We can provide the complete evaluation of most home medical devices and offer assistance in the product development to attain compliance. Contact us with your questions or to discuss how we can support your product approval.
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