EMC Directive inherently benign and borderline equipment

The Directive excludes equipment only when its inherent physical characteristics meet both parts of the statutory test: it cannot generate or contribute to emissions above a level that lets radio, telecommunications, and other equipment operate as intended, and it can operate without unacceptable degradation in the electromagnetic disturbance normally expected in its intended use.

The Commission EMCD guide gives examples that may be outside scope when they have no active electronic parts: cables and cable accessories considered separately, purely resistive loads without automatic switching, batteries without active electronic circuits, passive antennas, corded headphones or unamplified loudspeakers, simple pocket lamps without active electronic circuits, induction motors without electronic circuits, basic switches without active electronic components, electromagnetic relays or locks without active electronic parts, and certain protection equipment such as fuses or circuit breakers without active electronic parts.

Do not treat the example list as automatic clearance. If the product is not listed, or if active electronics, controls, firmware, power conversion, switching, radio functions, or unusual installation conditions are present, document the EMC assessment that supports any out-of-scope conclusion.

A finished appliance, or a combination made available as a single functional unit, is apparatus when it is intended for the end-user and is liable to generate electromagnetic disturbance or be affected by such disturbance. The end-user may be a consumer or a legal entity using the apparatus for its intended purpose; the EMCD guide notes that end-users are generally not assumed to have EMC qualifications.

Components and sub-assemblies are not always outside scope. They are treated as apparatus when they are intended for incorporation into apparatus by the end-user and they are liable to generate disturbance or be affected by disturbance. The guide gives examples that may be covered when placed on the EU market, including computer plug-in cards, programmable logic controllers, computer disk drives, USB memory sticks, separately sold power supply units for end-user installation, and electronic temperature controls.

A combination of CE-marked products is not automatically a compliant EMC system. If an economic operator makes several finished products available as one functional unit for an end-user to perform a specific task, the combination is assessed as one apparatus and the interaction of the products belongs in the EMC risk assessment.

A fixed installation is a particular combination of apparatus and, where applicable, other devices, assembled, installed, and intended for permanent use at a predefined location. Fixed installations are not handled like ordinary apparatus: the Directive says they need not carry CE marking or an EU declaration of conformity, but they must meet the essential requirements and use good engineering practices.

The borderline issue is often equipment intended for one particular fixed installation. Apparatus that is made available on the market and may be incorporated into a fixed installation normally remains subject to the apparatus provisions. The exception is narrow: if the apparatus is intended for incorporation into a particular fixed installation and is otherwise not made available on the market, Articles 6 to 12 and 14 to 18 are not compulsory, but the accompanying documentation must identify the fixed installation, its EMC characteristics, and the precautions for incorporation.

For the installation itself, define the geographic boundary and interfaces where conducted or radiated disturbances may cross into or out of the installation. Keep the good-engineering-practice documentation for as long as the fixed installation is in operation, because authorities may request evidence where there are indications of non-compliance or complaints about disturbances.

A good scope record should let a reviewer see why the item was excluded, treated as apparatus, handled as a component/sub-assembly, or managed through the fixed-installation route. The record should connect the conclusion to the product facts rather than only citing the Directive.

For an inherently benign conclusion, keep the physical-characteristics analysis, a list of active electronic parts or confirmation that none are present, the intended electromagnetic environment, and the reason both the emissions and immunity limbs are met. For borderline apparatus or components, keep end-user and intended-use evidence, product configuration, EMC phenomena considered, applicable standards if used, and the rationale for any omitted tests or reduced assessment.

For fixed-installation decisions, keep the installation identity, boundary, EMC characteristics, incorporation precautions, manufacturer instructions used, good-engineering-practice evidence, and the person responsible for establishment of compliance. If a complaint, incident, supplier change, firmware change, component change, or standard change affects the conclusion, reopen the record.