What is the EMC Directive?
The new EMC Directive 2014/30/EU replaces the old EMC Directive 2004/108/EC. The EMC Directive is the only EU directive whose background is not directly human safety [1]. The Electromagnetic Compatibility Directive (EMC) aims to minimize the side effects caused by interference between electromagnetic devices. According to the directive, electronic compatibility means the ability of a device to function satisfactorily in its electromagnetic environment without unduly disturbing other devices in this environment.
The purpose of the Directive is to ensure the free movement of equipment in the European Union and to create an acceptable electromagnetic environment in the territory of the Union [2]. In order to regulate electromagnetic compatibility, the Directive pursues the following objectives
- Equipment shall comply with the requirements of the EMC Directive when made available on the market and/or put into operation, when properly installed, maintained and used for the intended purpose
- in the case of fixed installations, the use of good engineering practice is required, with the possibility for the competent authorities of the Member States to require proof of conformity of the fixed installation and, where appropriate, to initiate an assessment when non-conformities are detected.
Why is it important that products comply with the EMC directive and are electromagnetically compatible?
Electromagnetic interference is a form of electrical pollution that is increasingly affecting the acceptance of electronic products, such as:
- Intermittent dispensers
- Battery toys that interfere with radio and television reception
- Household appliances that need to be kept apart - two properly CE-marked household appliances, when placed next to each other, interfere with each other.
- TETRA and car alarm systems
- Powerline systems and amateur radio communication
- Problems with aircraft navigation (in-flight and radio beacons) caused by LED lights
- Mobile phones and medical devices
- Electronic devices that are relatively close to each other, such as in a house microwave oven and washing machine, can interfere with each other. It must be applied
if the electromagnetic interference exceeds the level from which radio and telecommunications devices or other devices can no longer operate as intended and if they do not have a degree of immunity to electromagnetic interference, which is to be expected in their intended use and which enables their operation without unreasonable impairment of the intended use.
Which products are affected by the directive and must bear the CE marking?
The Directive generally applies to a wide range of equipment, including electrical and electronic equipment, apparatus and systems. For the purposes of the Directive, the term "equipment" is defined as any device or fixed installation. Components and assemblies are also included.
What are equipment according to the EMC directive must bear the CE marking (devices, components, assemblies and stationary systems)?
The operation means include devices and stationary systems, components and assemblies.
A "device" is any finished device or combination thereof provided as a single functional unit on the market, is intended for the end user and may cause electromagnetic interference or whose performance may be affected by such interference [3]. These include, for example
- lighting products such as LED lighting,
- LED TV,
- Mixer,
- Ovens,
- Fridges,
- Electric motors,
- Lithium batteries
"Components" or "assemblies" intended for installation in a device by the end user, as well as "portable equipment" shall also be considered as devices under Article 3 paragraph 2 of the Directive [2]. Examples are:
- Plug-in cards for computers,
- Computer drives,
- USB memory sticks,
- SD cards. "2
A "fixed installation" is a particular combination of several types of equipment and, where appropriate, other equipment assembled, installed and intended to be used permanently in a predetermined location [3].
Which products are exempt from the EMC Directive?
Equipment that does not contain electrical and/or electronic parts does not produce electromagnetic interference and its normal operation is not affected by such interference. Therefore, devices without electrical and/or electronic parts are not covered by the EMC Directive".
In addition, there are equipment which are explicitly excluded from the scope of the EMC Directive [3], including:
- Aviation products
- Radios (for the CE marking of these, the radio RL applies).
- Radios intended for use by radio amateurs (for the CE marking of which the radio RL applies).
- Equipment covered by other specific Union legislation, such as equipment already covered by Directive 1999/5/EC and others such as marine equipment (Directive 2014/90/EU), medical devices, agricultural and forestry tractors (Regulation (EU) No 167/2013)
- Inherently benign devices: A device is considered benign if the device is unable to contribute to electromagnetic emissions exceeding a level that allows the proper operation of radio and telecommunications devices and other devices.
- if they operate without unreasonable impairment in the event of electromagnetic interference that occurs during normal use.
- For example, cable accessories, quartz watches, batteries and accumulators without active electronic circuits (here, for the CE marking, the RoHS-RL or the construction productA)
- Customized evaluation kits intended for professionals and used exclusively in research and development facilities for such purposes
Which requirements or obligations must manufacturers comply? Do you comply with the EMC directive so that you can mark your product CE?
For the CE marking of an EMC product, the manufacturer or distributor must comply with 9 different obligations:
- The devices must be designed and manufactured in such a way as to limit the emission of interference, taking into account the prior art.
- Furthermore, the products must have a reasonable degree of immunity.
- There are additional requirements for fixed installations.
What additional product properties do manufacturers have to prove for stationary systems in order to be allowed to wear CE marking according to EMC?
Specific requirements for fixed installations from Annex 1 to the Directive:
- Installed using good engineering practice.
- The responsible person must keep the documents available for inspection.
- Information about the intended use of its components must be observed.
Is the evaluation of electromagnetic compatibility absolutely necessary for the CE marking?
Yes, there is no obligation to involve a third party - a notified body or an EMC testing laboratory - in the process. The decision on this is the sole responsibility of the manufacturer. From our experience, however, commissioning a test laboratory is usually the safest, fastest and cheapest way. The manufacturer must carry out an assessment of the electromagnetic compatibility of the device in order to meet the essential requirements (in accordance with Annex I). The EMC assessment shall also take into account the normal intended operating conditions.
If, after the EMC assessment, the device proves to be harmless in terms of electromagnetic compatibility (both for emission and immunity) in accordance with Article 2 paragraph 2d, it shall not fall within the scope of the EMCDirective and no further action is required. However, it is advisable to keep the results of the evaluation.
What is the risk assessment process for the CE conformity assessment of an EMC product?
- Analysis of risks: First, the risks are analyzed, both general and specific. After the risks have been identified and the manufacturer has determined the preventive or corrective measures to minimize these risks and to comply with the essential requirements, he may choose to apply the harmonized standards applicable to his product or to choose other technical specifications.
- EMC evaluation: After the risks of the device have been determined, three methods for EMC evaluation are possible:
- a. Application of the harmonized EMC standards after checking whether the selected harmonized(s) standard(s) cover/cover all phenomena relevant to the product.
- b. An EMC assessment in which no harmonized standards have been applied and the manufacturer applies its own methodology (other technical specifications).
- c. A mixed assessment combining the two previous methods. For example, harmonized standards could be used to cover emission phenomena and a detailed technical EMC assessment for immunity aspects.
Which technical documentation must be written and provided as part of the CE conformity assessment of an EMC product?
So that a product may bear the CE mark according to EMC, the manufacturer or. Distributors create a technical documentation according to requirements and make it available (in the future also online). This serves as proof of conformity of the device with the essential requirements of this Directive. The documents must contain the following information:
- Identification of the product: this identification should allow a clear association between the technical documentation, the EU declaration of conformity and the product
- General description of the device: A complete description may be required for a complex device (it is advisable to attach a picture)
- Designs, manufacturing drawings and plans of components, subassemblies, circuits, etc.
- Descriptions and explanations necessary to understand these drawings and plans and the operation of the device
- Where harmonized standards have been applied, proof of compliance with those standards is required. This is at least a dated list of the harmonized European standards applied and the results obtained in their application. From our experience, the manufacturer or marketer should also purchase these standards for proof.
- Where harmonized standards have not been applied or only partially applied, a description of the steps taken to meet the essential requirements
- an EMC assessment - as described in Annex II to the Directive - must be included. The documentation includes test reports, performed design calculations, performed investigations, etc. Therefore, the commissioning of a test laboratory is advisable in order to be able to prove the EMC assessment quickly and correctly.
- Where a manufacturer applies the procedure set out in Annex III to the EMC Directive, the EU type-examination certificate issued by a notified body shall be attached.
- An EU declaration of conformity for the product must be drawn up.
- The CE mark must be affixed to the product.
What is the EU declaration of conformity and what does it look like for an EMC product?
A Declaration of Conformity (EU declaration of conformity - DoC) is issued by the manufacturer based inside or outside the EU or its authorised representative in the EU. It is a declaration of conformity of the equipment with all relevant essential requirements. Since the declaration of conformity is an "official" declaration of compliance with the legislation, it must be signed by the manufacturer or his authorized representative (signature). When preparing the EU declaration of conformity, the manufacturer assumes responsibility for the device’s compliance with the requirements of this Directive.
The declaration of conformity must contain the following information:
- Device model/product (product, type, batch or serial number)
- Name and address of the manufacturer or his authorised representative
- the EU declaration of conformity is issued under the sole responsibility of the manufacturer
- the subject-matter of the application (identification of devices enabling traceability; it may contain a colour image of sufficient clarity where necessary to identify the device)
- that the purpose of the declaration described above is consistent with the relevant Union harmonisation rules
- Where appropriate, the notified body ... (name, number) carried out ... (description of the intervention) and issued the certificate ... (EU type-examination certificate number)
- Additional information
- Signed for and on behalf of
- Place and date of issue
- Name, function and signature.
How should the CE marking be applied to an EMC product?
The device bears the CE marking as a certificate of compliance with the EMC directive. The CE marking must be affixed visibly, legibly and indelibly to the device or its data label. If this is not possible or not justified due to the type of device, it shall be affixed to the packaging and accompanying documentation [2].
Which harmonized standards are often included in conformity assessment according to the EMC Directive?
In the following, we list some harmonized standards that are often taken into account in our experience in the context of conformity assessment according to EMC. These standards support the presumption of compliance with essential requirements of the EMC Directive:
- EN 55022 It-Tech equipment - Radio interference characteristics - Limit values and measurement methods
- EN 55032 Electromagnetic compatibility of multimedia devices - Emission requirements
- EN 61000-6-1/2/3/4 Generic standards,
- The latest harmonized standard is EN 12895:2015+A1:2019 Industrial Truck - Electromagnetic Compatibility.
