New medical EMC standard IEC 60601-1-2 4th edition

New medical EMC standard IEC 60601-1-2 4th edition New medical EMC standard IEC 60601-1-2 4th edition New medical EMC standard IEC 60601-1-2 4th edition
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The 60601-1 collateral standard for medical EMC is 60601-1-2, presently the 3rd edition of the standard is in force. However in December 2018 newly certified (or recertified) medical devices will be required to meet the more rigorous requirements from the 4th edition. Therefore, most medical equipment manufacturers are opting for doing EMC evaluations to the 4th edition at the current time.

While this EMC standard covers both emissions and immunity aspects of medical product design, the emissions requirements for the 4th edition are fundamentally unchanged from the 3rd edition. Note, these emissions requirements are Class B CISPR11 (Conducted and Radiated) and 61000-3-2 (Line Harmonics).

The following table details the changes in immunity test requirements from the 3rd to the 4th edition, as well as the enhanced immunity capabilities of the new Globtek GTM96 series of power supply product line.

The United States FDA has set a transition date of December 31 2018 and it’s standard for this requirement can be found at their website: http://www.accessdata.fda.gov/scrip\ ts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32630

60601-1-2 Immunity Test Level

Immunity Test3th ed criteria4th ed criteriaEnhanced GT EL6 GTM96XXX Family Product Capability
ESD
61000-4-2
6KV Contact
8KV Air
8KV Contact
15KV Air
10KV Contact
18KV Air
Radiated RF
61000-4-3
3V/m, 80-2500MHz, General Medical Equip

10V/m, 80-2500MHz, Life Support Equip

3V/m, 80-2500MHz, Professional Healthcare Facility

10V/m, 80-2500MHz, Home Healthcare Environment

Same as 4th ed Criteria

EFT

61000-4-4

2kV on AC input, 5KHz Repetition

3x -- to Line, Neutral and Earth

2kV on AC input, 100KHz Repetition

3x -- to Line, Neutral and Earth

4kV on AC input, 100KHz Repetition

3x -- to Line, Neutral and Earth

Surge (Lightning)

61000-4-5

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

500V,1kV,2kV,4kV common mode, 500V,1kV,2KV differential mode on AC input lines #

Conducted RF

61000-4-6

3Vrms, 0.15-80MHz on AC input

3Vrms, 0.15-80MHz on AC input

Same as 4th ed Criteria

Dips and Dropouts

61000-4-11

Dip to 40% for 5 cycles (100 ms)

Dip to 70% for 25 cycles (500ms)

Dropout to 5% for 10 ms

Interrupt >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

Interrupt 100% for 250/300 cycles-

Same as 4th ed Criteria

# GTM96060 Enhanced Surge capability limited to 1.5kV for differential mode

GlobTek products compliant with IEC 60601-1-2 4th edition:

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