Host Integration Permissive Changes and Modular Approval Dossier Scope
Host integration of approved radio modules requires strict permissive change assessment and tailored dossier compilation to preserve regulatory market access.
SAR Exemption
Meaning
Regulatory provision allowing a wireless device to bypass specific absorption rate testing based on low output power or separation distance. A sar exemption is granted when a device operates at levels where the radio frequency energy deposited in human tissue is proven to be below the safety limits. This status simplifies the certification process for small, low-power devices like Bluetooth beacons or wearables.
The calculation for the waiver is based on the maximum conducted power and the intended use case.
Power Threshold
Limits for the radiated energy are defined by the operating frequency and the proximity to the body. If the source-based time-averaged power is lower than the specified milliwatt level, a sar exemption is applicable. This limit scales with frequency because higher frequencies have different absorption characteristics.
Separation Distance
Physical gap between the radiating element and the user is a primary factor in the evaluation. A sar exemption for a tablet might depend on the antenna being located more than 20 centimeters from the body during normal operation. Devices used closer to the head or torso face much stricter power limits to qualify for this path.
Manufacturers must declare the minimum distance in the user manual to maintain the validity of the claim.
Compliance Documentation
Technical justification for the waiver must be included in the regulatory filing. The analysis for sar exemption replaces the physical SAR report that would otherwise require testing with a phantom model and liquid stimulants. It includes the calculation of the maximum power including tune-up tolerances and antenna gain.
Regulators review this math to ensure that the safety of the end user is guaranteed by the physical properties of the device.