1. What is IEC60601-1-2?
IEC60601-1 is safety standard applicable to medical electrical equipment.
Especially, IEC 60601-1-2 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by ME equipment and ME systems.
The latest version of IEC60601-1-2 is Ed.4th (2014).
Fig.1 System of IEC60601-1
2. Difference from 3rd Edition of IEC60601-1-2
Table 2 show 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 | ±6kV(Contact),±8kV(Air) | ±8kV(Contact),±15kV(Air) |
| 2 | Radiated, RF, electromagnetic field immunity test | IEC61000-4-3 | 10V/m(80MHz～2.5GHz) | 10/m*(80MHz～2.7GHz) |
| 3 | Electrical fast transient / burst immunity test | IEC61000-4-4 | Repetition rate:5kHz | Repetition rate:5k/100kHz |
| 4 | Power frequency magnetic field immunity test | IEC61000-4-8 | 3A/m | 30A/m |
3. IEC60601-1-2 4th Edition Compatibility.
EMI/EMS compatibility of our product are confirmed by as single unit.
For more details, please visit out website, and download the files.
"Document Download"--> Technical data"--> "EMC Data"
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