New medical EMC standard IEC 60601-1-2 4th edition
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 Test | 3th ed criteria | 4th ed criteria | Enhanced 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 | |||