Designing Safer Medical Devices: EMI/EMC Compliance Made Simple
IEC 60601-1 is a regulatory standard that governs the safety and essential performance of medical electrical equipment. It ensures that devices, from infusion pumps to neurostimulators, are safe for patients, healthcare providers, and their operating environment. This includes protection against electromagnetic interference (EMI) and ensuring electromagnetic compatibility (EMC), which is critical for preventing malfunctions and maintaining reliable operation in complex clinical settings.
Key requirements of IEC 60601-1 are:
- Essential Performance: The device must continue to perform its intended function safely under expected conditions including fault tolerance, alarm systems, and usability under stress.
- Electromagnetic Compatibility: Devices must limit emissions and demonstrate immunity to external EMI. IEC 60601-2 is the collateral standard that defines testing protocols.
- Radiation Protection: For devices emitting ionizing or non-ionizing radiation, shielding and exposure limits must be controlled.
To meet these requirements, manufacturers must address the following:
- Emissions: The level of electromagnetic energy a device radiated into its surroundings.
- Immunity: The device’s ability to operate reliably when exposed to external EMI.
- Susceptibility: The likelihood that the device will malfunction or degrade in performance due to EMI from nearby electronics.
Why is Simulation Key to EMC Success?
Simulation helps designers address these issues earlier and faster compared to physical testing. With simulation teams can identify and resolve problems before physical prototypes are built, avoiding costly redesigns and delays later in the process.
Be confident your product will pass EMC certification on the first try with Ansys EMC Plus. EMC Plus is a platform-level electromagnetic modeling and simulation tool that delivers design-to-validation workflow for EMC.
Designers can analyze:
- Radiated emissions
- Coupling to cables
- Shielding effectiveness
- EMI crosstalk between cables
- Current return network optimization
- Cable signal integrity
EMC Plus was used to successfully simulate EMI across a full Intel server system, demonstrating its capability for platform-level analysis. Ongoing validation efforts are now extending to broader electronic applications. You can explore the full case study here, and follow the latest updates here.
Leveraging advanced simulation with EMC Plus, medical device manufacturers can streamline IEC 6061-1 compliance, reduce development costs, and improve product reliability. Working with EMA ensures safer, smarter, and more resilient medical technologies for the environments and lives they serve.
Reach out to EMA now to learn more and get started! Contact us by clicking here.
