Radiometrics Midwest Corporation provides EMC testing for medical electrical equipment and medical devices at our A2LA-accredited EMC laboratory in Illinois.
Medical products must operate reliably in electromagnetic environments while limiting electromagnetic disturbances that could affect other equipment. Radiometrics performs emissions and immunity testing for medical equipment and can support manufacturers during product development, pre-compliance evaluation, formal compliance testing and EMC troubleshooting.
IEC 60601-1-2 Medical EMC Testing
IEC 60601-1-2 establishes electromagnetic disturbances requirements and tests for medical electrical equipment and medical electrical systems.
The standard addresses both electromagnetic emissions and immunity. The applicable test levels, configurations and performance criteria depend on the equipment, intended use and electromagnetic environment.
Radiometrics can review the product configuration and applicable requirements with the manufacturer before testing begins.
FDA Medical Device EMC Testing
Electromagnetic compatibility testing can be an important part of the documentation supporting FDA submissions for electrically powered medical devices.
Radiometrics provides EMC testing for medical devices associated with regulatory submissions, including products being prepared for FDA 510(k) and Premarket Approval (PMA) processes.
Because the applicable EMC requirements depend on the device, intended use, electromagnetic environment and regulatory pathway, manufacturers should establish the applicable requirements for their device before beginning the formal test program.
Medical Device EMC Testing Capabilities
Depending on the applicable requirements, Radiometrics can provide:
- Radiated emissions testing
- Conducted emissions testing
- Electrostatic discharge immunity
- Radiated RF electromagnetic field immunity
- Electrical fast transient/burst immunity
- Surge immunity
- Conducted RF immunity
- Power-frequency magnetic field immunity
- Voltage dips and interruptions testing
- Pre-compliance EMC evaluation
- EMC troubleshooting and engineering support
Detailed information about the individual immunity methods is available on our IEC 61000-4 EMC Immunity Testing page.
Testing can be coordinated so emissions and immunity evaluations are performed as part of an integrated medical-device EMC program.
Wireless Coexistence and Specialized Medical Equipment
Medical devices increasingly incorporate Wi-Fi, Bluetooth and other wireless technologies or operate in environments containing multiple wireless systems.
Radiometrics can perform applicable wireless coexistence evaluations, including testing associated with ANSI C63.27.
Radiometrics also has experience with specialized electrically powered medical and mobility equipment. Applicable requirements may include standards for powered wheelchairs and mobility devices, including ISO 7176-21 and EN 12184.
For specialized medical products, including implant-related equipment, Radiometrics can review the applicable product requirements and determine which EMC tests fall within our laboratory capabilities.
Radiated and Conducted Emissions
Medical electrical equipment must meet applicable electromagnetic emissions requirements.
Radiated emissions testing evaluates unwanted RF energy emitted by the equipment and associated cables.
Conducted emissions testing evaluates RF disturbances coupled onto applicable power connections.
Radiometrics can evaluate equipment in representative operating modes and configurations to identify conditions producing the highest emissions.
Electrostatic Discharge — IEC 61000-4-2
Electrostatic discharge testing evaluates the ability of equipment to withstand ESD events that can occur through direct contact or nearby discharges.
Medical equipment may be exposed to ESD from operators, patients, furniture and other objects in the intended-use environment.
Testing is performed at applicable contact and air-discharge levels while equipment performance is monitored.
Radiated RF Immunity — IEC 61000-4-3
Radiated RF immunity testing evaluates the ability of medical equipment to operate properly when exposed to radio-frequency electromagnetic fields.
Potential RF sources can include mobile phones, radios, wireless networks and other transmitting equipment.
Radiometrics performs radiated immunity testing over the applicable frequency ranges and field strengths required by the medical EMC standard and product requirements.
Electrical Fast Transient/Burst — IEC 61000-4-4
Electrical fast transient testing evaluates immunity to repetitive bursts that can be coupled onto power, signal and control connections.
These disturbances can result from switching of inductive loads, relays and other electrical equipment.
Surge Immunity — IEC 61000-4-5
Surge testing evaluates the ability of equipment to withstand high-energy transient disturbances that can occur on power and applicable interconnection lines.
Testing is performed using the coupling methods, test levels and configurations required by the applicable medical EMC requirements.
Conducted RF Immunity — IEC 61000-4-6
Conducted RF immunity testing evaluates equipment susceptibility to RF disturbances coupled onto power, signal and other applicable cables.
This test complements radiated RF immunity by evaluating disturbances that reach the equipment through connected conductors.
Power-Frequency Magnetic Field Immunity — IEC 61000-4-8
Medical equipment may require evaluation of immunity to magnetic fields associated with AC power systems and nearby electrical equipment.
Radiometrics performs applicable power-frequency magnetic field immunity testing using the required field strengths and equipment configurations.
Voltage Dips and Interruptions — IEC 61000-4-11
Voltage dips and interruptions testing evaluates equipment behavior during reductions or interruptions of the AC supply voltage.
For medical electrical equipment, maintaining appropriate performance or recovering correctly following a power disturbance can be an important EMC consideration.
Essential Performance and EMC Testing
Medical EMC testing involves more than determining whether equipment resets or stops operating.
The manufacturer must establish the equipment functions that need to be monitored during immunity testing and the acceptance criteria applicable to those functions.
Radiometrics works with the manufacturer’s engineering personnel to implement appropriate operating modes, monitoring and performance criteria during the EMC test program.
Medical Equipment Configurations and Accessories
Medical electrical equipment can include accessories, cables, sensors, patient-connected leads, peripherals and support equipment that affect EMC performance.
Representative configurations should be considered when developing the test program.
Providing this information before testing helps Radiometrics establish an efficient test setup and identify equipment needed to exercise and monitor the product.
Pre-Compliance Medical EMC Testing
Pre-compliance testing can identify EMC problems while a medical product is still under development.
Focused emissions or immunity testing can be used to evaluate design changes, cable configurations, shielding, filtering and other potential EMC issues before formal compliance testing.
This can be particularly valuable when changes to a medical device after formal testing would require additional documentation, engineering review or retesting.
Medical EMC Troubleshooting
If a medical device fails an emissions or immunity test, Radiometrics can work with the manufacturer’s engineering team to characterize the problem.
Potential areas of investigation can include:
- Shielding
- Grounding and bonding
- Cable configuration
- Power-input filtering
- Signal and patient-connected leads
- Enclosure design
- Power supplies
- Digital circuitry
- Equipment operating modes
Where practical, corrective changes can be evaluated during testing to determine whether they improve EMC performance.
Information Needed for a Medical EMC Quote
Please provide the following information when available:
- Product description and model number
- Applicable standard and edition
- Product dimensions
- AC or DC power requirements
- Number and type of external cables
- Patient-connected leads, when applicable
- Accessories and peripherals
- Normal and worst-case operating modes
- Functions requiring monitoring during immunity testing
- Manufacturer-defined performance criteria
- Intended electromagnetic environment
- Previous EMC reports or test data, when available
If the required test program is uncertain, Radiometrics can review the product information and applicable EMC requirements before preparing a quotation.
Why Radiometrics for Medical Device EMC Testing?
Radiometrics has provided EMC testing and engineering services since 1983. Our laboratory combines emissions and immunity testing capabilities with experienced EMC engineers who can assist manufacturers from early development through formal compliance testing.
Because Radiometrics performs the individual IEC 61000-4 immunity methods as well as emissions testing, manufacturers can coordinate a substantial portion of the medical EMC program through one laboratory.
Schedule Medical Device EMC Testing
Contact Radiometrics to discuss IEC 60601-1-2 testing, medical device emissions and immunity testing, pre-compliance evaluation, troubleshooting, scheduling or quotation requirements.