Q&A(FAQ) What is IEC60601-1-2 Ed. 4th?
1. What is IEC60601-1-2?
IEC 60601-1 is the safety standard applicable to medical electrical equipment.
IEC 60601-1-2 specifically covers the basic safety and essential performance of Medical Electrical (ME) equipment and ME systems in the presence of electromagnetic disturbances, as well as the electromagnetic disturbances emitted by such equipment and systems.
The latest version of IEC60601-1-2 is Ed.4th (2014).
2. Difference from 3rd Edition of IEC60601-1-2
Table 2 shows the difference of requirement between 3rd Edition and 4th Edition. There are test items which the requirement becomes more strict.
| No. | Test | Reference Standard |
Requirement | |
|---|---|---|---|---|
| Ed.3rd （IEC60601-1-2:2007） |
Ed.4th （IEC60601-1-2:2014） |
|||
| 1 | ESD | IEC61000-4-2 | ±6 kV(Contact), ±8 kV(Air) | ±8 kV(Contact), ±15 kV(Air) |
| 2 | Radiated, RF, electromagnetic field immunity test | IEC61000-4-3 | 10V/m(80 MHz ~ 2.5 GHz) | 10V/m(80 MHz ~ 2.7 GHz) |
| 3 | Electrical fast transient / burst immunity test | IEC61000-4-4 | Repetition rate: 5 kHz | Repetition rate: 5 kHz / 100 kHz |
| 4 | Power frequency magnetic field immunity test | IEC61000-4-8 | 3A/m | 30A/m |
3. IEC60601-1-2 4th Edition Compatibility.
The EMI/EMS compatibility of our products has been verified on each unit individually.
Please refer to each product page for the test data.