Meaning
Harmonised standards under the European Radio Equipment Directive specify the assessment methods for electronic products to protect human health from radio frequency radiation. The standard EN 50665 governs the evaluation of low-power electronic and electrical devices with respect to electromagnetic field exposure limits between zero hertz and three hundred gigahertz. This framework covers equipment that has no dedicated product-specific or product-family standard and has a transmitted power below the threshold where it could cause harmful exposure.
Exposure Limit
Human protection targets are based on preventing thermal effects from high-frequency fields and nerve stimulation from low-frequency fields. If a device has an output power below twenty milliwatts, it is assumed to comply without needing detailed physical measurements.
Verification Method
Laboratory validation utilizes a sequence of simplified assessments to confirm that a device meets the safety criteria without requiring full laboratory testing if possible. If the power level is above the low-power exclusion threshold, the assessment transitions to a detailed investigation using numerical simulation or physical tissue phantoms. The simulation must replicate the physical architecture of the transmitter and the housing to yield an accurate model of the electromagnetic field distribution.
These results are compiled into a technical construction file that provides legal proof of compliance.
System Compliance
Integration of pre-certified modules into a larger host enclosure requires a reassessment of the composite product to ensure the final assembly remains compliant. While an individual wireless module might hold a compliance declaration, mounting it near metallic structures within a smart device can distort the radiation pattern and create localized field hot spots. System integrators must evaluate the combined fields when multiple radio modules are operating simultaneously in the same housing.