Electromagnetic Compatibility (EMC) is two-folded. The device is expected to function and perform safely without interfering with other devices and systems in the electromagnetic environment in which the manufacturer has intended the device to be used throughout their expected service life.
Secondly, EMC is that the device shall be adequately immune to the electromagnetic phenomena in the environments in which the manufacturer has intended the device to be used throughout their expected service life.
IEC 60601-1-2 is one of the collateral standards within IEC 60601-1 and it concerns electromagnetic disturbances. It is a risk-based standard. Although this standard scope includes medical devices, the requirements are mostly standardized to cover other electrical devices and are universal.
The IEC 60601-1-2 standard is essential for medical device manufacturers. The standard covers an essential part of compliance with the EU MDR and FDA requirements.
Note, that FDA does not recognize the EMC standard for IVD devices, which is IEC 61326-2-6. FDA highlights that the IVD standard confers less expectation of predictability than the FDA-recognized IEC 60601-1-2 standard or provides only part of a complete immunity test for products.
About the IEC 60601-1-2 Standard
The IEC 60601-1-2 standard includes 102 pages and covers, e.g.:
– General requirements: risk management, non-medical equipment, test conditions
– Identification, marking and documents
– Documentation of the tests
– Electromagnetic emission and immunity requirements
The IEC 60601-1-2 standard is a harmonized standard for the Medical Device Directive. It will be harmonized to the Medical Device Regulation ETA in 2024 as EN 60601-1-2.
IEC 60601-1-2 training
Labquality provides IEC 60601-1-2 standard training, which will provide you with essential knowledge about the EMC, the standard and how to use it.
Although this training introduces the EMC phenomenon utilising the medical device standard IEC 60601-1-2, the EMC is a phenomenon related to all electrical devices. The most common EMC requirements for electrically operated products are covered.
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