What is EN 60601-1-2:2015?

EN 60601-1-2:2015 is a technical standard that specifies the basic safety and essential performance requirements for electromagnetic compatibility (EMC) in medical electrical equipment. This standard, published by the International Electrotechnical Commission (IEC), covers the potential risks associated with electromagnetic disturbances and provides guidelines for minimizing interference between medical equipment and other devices or systems.

Key Requirements of EN 60601-1-2:2015

One of the key requirements of EN 60601-1-2:2015 is that medical electrical equipment must be designed and tested to ensure its immunity to electromagnetic disturbances. This includes both intentional radiation from other equipment and unintentional radiated or conducted signals. The standard sets limits for emissions and requires proper grounding and shielding to minimize interference.

In addition, the standard also addresses the susceptibility of medical electrical equipment to electromagnetic disturbances. It specifies criteria for proper performance under certain conditions and requires appropriate design measures to prevent malfunctions or hazards caused by external electromagnetic sources.

Testing and Compliance

To comply with EN 60601-1-2:2015, manufacturers of medical electrical equipment must undergo rigorous testing and evaluation. This typically involves measuring and analyzing the equipment's emissions and susceptibility to electromagnetic disturbances in controlled environments. Testing is performed using specialized equipment and techniques to ensure accurate and reliable results.

Once testing is complete, manufacturers must document the test results and provide evidence of compliance. This information is often included in the product's technical documentation and made available to regulatory authorities and customers.

Benefits of Compliance

Complying with EN 60601-1-2:2015 offers several benefits for manufacturers of medical electrical equipment. Firstly, it ensures that the equipment meets minimum safety requirements and reduces the risk of interference or malfunction caused by electromagnetic disturbances.

Secondly, compliance facilitates market access by demonstrating that the equipment has undergone comprehensive testing and evaluation. This can help manufacturers gain regulatory approvals and certifications, making it easier to distribute their products globally.

Lastly, compliance with this standard enhances the reputation and credibility of manufacturers, as it demonstrates their commitment to producing safe and reliable medical equipment.