Technical​ Articles

Understanding Medical EMC 4th Edition (IEC 60601-1-2:2014)

Categories : Power Supply Safety Standard

The International Electrotechnical Commission (IEC) in 2014 published the updated revision of the electromagnetic compatibility (EMC) requirements for medical devices, the IEC 60601-1-2:2014, so called 4th edition, with an effective date of April 1, 2017. This revision makes changes to immunity requirements and the analysis of risk management for electromagnetic disturbances of medical devices, in order to make them safer for use in three specifically intended environmental categories: 1) Professional healthcare, 2) Home healthcare, and 3) Special environments.


Delta’s MDS ATX series of medical power supplies is suitable for use in medical devices with Type BF classification.


With the roles that power supplies play in medical devices, it is important for Delta to help Design Engineers achieve the most efficient and expeditious way for their designs to meet the 4th edition standard for medical systems and devices. The 3rd edition standard requirements are based on the purpose of the equipment, rather than the environment that it was intended to be used in. The 4th edition standard requirements are broken down into three intended use environmental categories:

  • Professional Healthcare - Hospitals, clinics, other medical facilities
  • Home Healthcare - Homes, public spaces
  • Special Environments - Military installations, industrial zones

These categories more accurately define the operation of medical devices and systems in everyday life, where devices, such as mobile devices or other equipment, may be operating concurrently. Alongside intended use environmental categories, comes new “Intended Use” and “Normal Use” definitions, where:

  • Intended use is for the intended medical purpose
  • Normal use is for purposes such as transportation, maintenance, standby


      

Delta’s MDS Open Frame and MDS Enclosed series of medical power supplies can be used in a wide variety of equipment for medical and ITE applications.


Beyond use within environmental categories, technical changes within 4th Edition include:

A) Immunity test level increases:

  • The range of testing for radiated immunity harmonized up to 2.7GHz (up from 2.5GHz in the 3rd edition)
  • Magnetic immunity at 30A/m
  • Conducted immunity at 6V in ISM bands
  • ESD at 8kV contact and 15kV air (up from 6kV and 8kV respectively in the 3rd edition)
  • Voltage dips and interruptions at additional phase angles

B) Changes to Immunity testing:

  • Immunity test levels are harmonized with IEC 60601-1-11
  • Immunity testing now follows the same port-by-port convention of the IEC 61000-6 series of Generic EMC standards
  • Immunity to proximity fields from RF wireless communications equipment is now included, and is based on a minimum separation distance of 30cm
  • There is a procedure for continuing to test a product that is damaged by an immunity test signal

C) Expansion of Risk Management:

  • Product manufacturers will be required to submit a test plan and the risk analysis document before testing
  • Operating modes are based on risk analysis
  • Reasonably foreseeable electromagnetic disturbances shall be taken into account in the risk management process
  • The risk management process is used to determine whether subsystem testing is allowed


      

Delta’s MDS Adapter series rides on Delta’s market leading adapter technology to provide the same high quality external power supplies for medical systems and equipments.


Table of Immunity Changes:

PortBasic Standard for Test Method
EN 60601-1-2:2007
IEC 60601-1-2: 2014
Professional Healthcare Facility Environment
Home Healthcare Environment
Enclosure Port
IEC 61000-4-2

6 kV (Contact discharge)

8 kV (Air discharge)

8 kV (Contact discharge)

15 kV (Air discharge)

8 kV (Contact discharge)

15 kV (Air discharge)

IEC 61000-4-3
80 to 2500 MHz / 10 V/m for LIFE-SUPPORTING
80 to 2700 MHz / 3 V/m
80 to 2700 MHz / 10 V/m
80 to 2500 MHz / 3 V/m for not LIFE-SUPPORTING
Frequency: up to 5785MHz Level: up to 28V/m
Frequency: up to 5785MHz Level: up to 28V/m
IEC 61000-4-8

50,60 Hz

3 A/m

50 or 60 Hz

30 A/m

50 or 60 Hz

30 A/m

AC input power port
IEC 61000-4-4
2 kV
2 kV / 100kHz
2 kV / 100kHz
IEC 61000-4-5
1 kV line to line 2 kV line to earth
1 kV line to line 2 kV line to earth
1 kV line to line 2 kV line to earth
IEC 61000-4-6
0.15 to 80 MHz / 10 V for LIFE-SUPPORTING
0.15 to 80 MHz / 3 V
0.15 to 80 MHz / 3 V
0.15 to 80 MHz / 3 V for not LIFE-SUPPORTING
6 V in ISM bands
6V in ISM bands & amateur radio bands
IEC 61000-4-11
<5 % UT for 0,5 cycle
<5 % UT for 0,5 cycle
<0 % UT for 0,5 cycle
at step: 45°
at step: 45°
40 % UT for 5 cycles
0 % UT for 1 cycle
0 % UT for 1 cycle
70 % UT for 25 cycles
70 % UT for 25/30 cycles
70 % UT for 25/30 cycles
<5 % UT for 5 s
<5 % UT for 250/300 cycles
<5 % UT for 250/300 cycles
DC input power port
IEC 61000-4-4
2 kV
2 kV / 100kHz
2 kV / 100kHz
IEC 61000-4-5
N/A

1 kV line to line

2 kV line to earth

1 kV line to line

2 kV line to earth

IEC 61000-4-6
0.15 to 80 MHz / 10 V for LIFE-SUPPORTING
0.15 80 MHz / 3 V
0.15 to 80 MHz / 3 V
0.15 to 80 MHz / 3 V for not LIFE-SUPPORTING
6V in ISM bands
6V in ISM bands & amateur radio bands
ISO 7637-2
N/A
N/A
ISO 7637-2:2011
Signal input/output parts port
IEC 61000-4-4
1 kV / 5KHz
1 kV / 100kHz
1 kV / 100 kHz
IEC 61000-4-5
N/A
2kV line to earth for outdoor
2kV line to earth for outdoor
IEC 61000-4-6
0.15 to 80 MHz / 10 V for LIFE-SUPPORTING
0.15 to 80 MHz / 3 V
0.15 to 80 MHz / 3 V
0.15 to 80 MHz / 3 V for not LIFE-SUPPORTING
6V in ISM bands
6V in ISM bands & amateur
Patient coupling port
IEC 61000-4-2
N/A

8 kV (Contact discharge)

15 kV (Air discharge)

8 kV (Contact discharge)

15 kV (Air discharge)

IEC 61000-4-6
N/A
0.15 to 80 MHz / 3 V
0.15 to 80 MHz / 3 V
N/A
6V in ISM bands
6V in ISM bands & amateur radio bands


Delta Medical Power Supply products compliant with EMC 4th Edition (IEC 60601-1-2:2014):

Model NameType

Output

Voltage

Output

Current

Output

Power

Input

Voltage

Ingress

Protection

MOOPMOPP

Dimension

(L x W x D)

MDS-005AAS05 B
Adapter
5V
1A
5W
90-264Vac
IP22


56.5 x 39.5 x 28 mm
MDS-030AAC05
Adapter
5V
3A
15W
85-264Vac
IP22


88.0 x 53.5 x 27.5 mm
MDS-030AAC07
Adapter
7V
3A
21W
85-264Vac
IP22


88.0 x 53.5 x 27.5 mm
MDS-030AAC12
Adapter
12V
2A
24W
85-264Vac
IP22


88.0 x 53.5 x 27.5 mm
MDS-030AAC15
Adapter
15V
2A
30W
85-264Vac
IP22


88.0 x 53.5 x 27.5 mm
MDS-030AAC24
Adapter
24V
1.25A
30W
85-264Vac
IP22


88.0 x 53.5 x 27.5 mm
MDS-040APS12 B
Open Frame 
12V
3.33A
40W
90-264Vac



76.2 x 50.8 x 23.0 mm
MDS-040APS15 B
Open Frame 
15V
2.67A
40W
90-264Vac



76.2 x 50.8 x 23.0 mm
MDS-040APS18 B
Open Frame 
18V
2.22A
40W
90-264Vac



76.2 x 50.8 x 23.0 mm
MDS-040APS24 B
Open Frame 
24V
1.67A
40W
90-264Vac



76.2 x 50.8 x 23.0 mm
MDS-060AAS12 B
Adapter
12V
5A
60W
90-275Vac



135.0 x 62.0 x 34.1 mm
MDS-060AAS15 B
Adapter
15V
4A
60W
90-275Vac



135.0 x 62.0 x 34.1 mm
MDS-060AAS19 B
Adapter
19V
3.15A
60W
90-275Vac



135.0 x 62.0 x 34.1 mm
MDS-060AAS24 B
Adapter
24V
2.5A
60W
90-275Vac



135.0 x 62.0 x 34.1 mm
MDS-060BAS12 A
Adapter
12V
5A
60W
90-264Vac
IP22


135.0 x 62.0 x 34.1 mm
MDS-060BAS19 A
Adapter
19V
3.15A
60W
90-264Vac
IP22


135.0 x 62.0 x 34.1 mm
MDS-060BAS24 A
Adapter
24V
2.5A
60W
90-264Vac
IP22


135.0 x 62.0 x 34.1 mm
MDS-065APS12 B
Open Frame
12V
5.42A
65W
90-264Vac



101.6 x 50.8 x 30.0 mm
MDS-065APS15 B
Open Frame
15V
4.2A
63W
90-264Vac



101.6 x 50.8 x 30.0 mm
MDS-065APS18 B
Open Frame
18V
3.61A
65W
90-264Vac



101.6 x 50.8 x 30.0 mm
MDS-065APS24 B
Open Frame
24V
2.71A
65W
90-264Vac



101.6 x 50.8 x 30.0 mm
MDS-080AAS12 A
Adapter
12V
6.7A
80W
90-264Vac
IP22


150.0 x 75.0 x 40.0 mm
MDS-090AAS15 B
Adapter
15V
6A
90W
90-264Vac



150.0 x 60.0 x 35.0 mm
MDS-090AAS19 B
Adapter
19V
4.73A
90W
90-264Vac



150.0 x 60.0 x 35.0 mm
MDS-090AAS24 B
Adapter
24V
3.75A
90W
90-264Vac



150.0 x 60.0 x 35.0 mm
MDS-090BAS24 A
Adapter
24V
3.75A
90W
90-264Vac



150.0 x 75.0 x 40.0 mm
MDS-100AP401 B
Open Frame
5.1V, 12V, +15V, -15V8A, 3A, 0.8A, 0.8A
100W
90-264Vac



127.0 x 76.2 x 30.5 mm
MDS-100APS12 B
Open Frame
12V
8.33A
100W
90-264Vac



127.0 x 76.2 x 31.0 mm
MDS-100APS15 B
Open Frame
15V
6.7A
100W
90-264Vac



127.0 x 76.2 x 31.0 mm
MDS-100APS18 B
Open Frame
18V
5.55A
100W
90-264Vac



127.0 x 76.2 x 31.0 mm
MDS-100APS24 B
Open Frame
24V
4.17A
100W
90-264Vac



127.0 x 76.2 x 31.0 mm
MDS-100BPS12 B
Open Frame
12V
8.33A
100W
90-264Vac



101.6 x 50.8 x 31.8 mm
MDS-100BPS15 B
Open Frame
15V
6.7A
100W
90-264Vac



101.6 x 50.8 x 31.8 mm
MDS-100BPS18 B
Open Frame
18V
5.55A
100W
90-264Vac



101.6 x 50.8 x 31.8 mm
MDS-100BPS24 B
Open Frame
24V
4.17A
100W
90-264Vac



101.6 x 50.8 x 31.8 mm
MDS-150AAS12 B
Adapter
12V
10A
120W
90-264Vac



170.0 x 85.0 x 40.0 mm
MDS-150AAS19 B
Adapter
19V
7.9A
150W
90-264Vac



170.0 x 85.0 x 40.0 mm
MDS-150AAS24 B
Adapter
24V
6.25A
150W
90-264Vac



170.0 x 85.0 x 40.0 mm
MDS-200APB12 AA
Open Frame
12V
16.67A
200W
90-264Vac



101.6 x 50.8 x 35.6 mm
MDS-200APB24 AA
Open Frame
24V
8.33A
200W
90-264Vac



101.6 x 50.8 x 35.6 mm
MDS-200ADB12 AA

Open Frame

with metal enclosure

12V
16.67A
200W
90-264Vac



113.9 x 64.7 x 44.7 mm
MDS-200ADB24 AA

Open Frame

with metal enclosure

24V
8.33A
200W
90-264Vac



113.9 x 64.7 x 44.7 mm
MDS-250ADB12 AA

Open Frame

with metal enclosure

12V
20.84A
250W
90-264Vac



140.0 x 88.9 x 45.0 mm
MDS-250ADB24 AA

Open Frame

with metal enclosure

24V
10.41A
250W
90-264Vac



140.0 x 88.9 x 45.0 mm
MDS-250APB12 AA
Open Frame
12V
20.84A
250W
90-264Vac



127.3 x 76.5 x 36.1 mm
MDS-250APB24 AA
Open Frame
24V
10.41A
250W
90-264Vac



127.3 x 76.5 x 36.1 mm
MDS-300ADB12 AA

Open Frame

with metal enclosure

12V
25A
300W
90-264Vac



140.0 x 88.9 x 45.0 mm
MDS-300ADB18 AA

Open Frame

with metal enclosure

18V
16.66A
300W
90-264Vac



140.0 x 88.9 x 45.0 mm
MDS-300ADB24 AA

Open Frame

with metal enclosure

24V
12.5A
300W
90-264Vac



140.0 x 88.9 x 45.0 mm
MDS-300ADB48 AA

Open Frame

with metal enclosure

48V
6.25A
300W
90-264Vac



140.0 x 88.9 x 45.0 mm
MDS-300APB12 AA
Open Frame
12V
25A
300W
90-264Vac



127.0 x 76.2 x 35.6 mm
MDS-300APB18 AA
Open Frame
18V
16.66A
300W
90-264Vac



127.0 x 76.2 x 35.6 mm
MDS-300APB24 AA
Open Frame
24V
12.5A
300W
90-264Vac



127.0 x 76.2 x 35.6 mm
MDS-300APB48 AA
Open Frame
48V
6.25A
300W
90-264Vac



127.0 x 76.2 x 35.6 mm
MDS-350AD701

Open Frame

with metal enclosure

3.3V, 5V, 5Vsb,

+12V1, +12V2, -12V, -5V

8A, 9A, 1.25A,

8A, 8A, 0.25A, 0.1A

350W
90-264Vac



194.0 x 100.0 x 40.5 mm
MDS-400ADB12 AA

Open Frame

with metal enclosure

12V
33.33A
400W
90-264Vac



140.0 x 88.9 x 44.4 mm
MDS-400ADB24 AA

Open Frame

with metal enclosure

24V
16.67A
400W
90-264Vac



140.0 x 88.9 x 44.4 mm
MDS-400APB12 AA
Open Frame
12V
33.33A
400W
90-264Vac



127.0 x 76.2 x 35.6 mm
MDS-400APB24 AA
Open Frame
24V
16.67A
400W
90-264Vac



127.0 x 76.2 x 35.6 mm
MDS-400AUS19 B

Open Frame

with U Frame

19V
21.1A
400W
90-264Vac



198.0 x 97.0 x 41.5 mm
MDS-400AUS24 B

Open Frame

with U Frame

24V
16.67A
400W
90-264Vac



198.0 x 97.0 x 41.5 mm
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