Understanding the EMC Directive harmonized standards
All manufacturers providing electrical and electronic products or components for use in the European Union are required, under CE marking legislation, to comply with EMC Directive 2014/30/EU.
The assessment for electromagnetic compatibility (EMC) of equipment includes a determination of the potential for an electronic device to function correctly and safely when exposed to interference and the level of electromagnetic radiation emitted.
When seeking to demonstrate compliance to the directive, Element frequently sees a disconnect between the way manufacturers propose the process, and the reality of what must be completed to show due diligence.
From our experience, we estimate that four out of five manufacturers are still approaching the process based on the outdated requirements of the previous EMC Directive. Understanding which directive to comply with and what harmonized standards will support it allows our experts to provide a presumption of conformity.
How to comply with the EMC Directive?
The compliance process should always begin with a full risk analysis. Many of the hazards identified in a risk assessment will be covered by applying an appropriate harmonized standard. However, as not all hazards will necessarily be covered, the application of a harmonized standard on its own is not always sufficient for demonstrating compliance with either the EMC Directive or the EMC requirements of the Radio Equipment Directive (RED).
The manufacturer has a duty to select and apply the most appropriate harmonized standard and determine if the standard is fully adequate for the product and its environment or if the product requires additional tests before it can be placed on the market.
The risk assessment enables the manufacturer to marry the risks with the appropriate harmonized standard(s) and establish what additional tests might be necessary for any risks not covered.
To ensure best practice approach, the European Commission’s guide to the EMC Directive 2014/30/EU on the harmonization of the laws of the Member States relating to electromagnetic compatibility can be a useful tool to avoid any ambiguities. Particularly regarding additional duties that may not have been required under the previous directive.
The EMC Directive 2014/30/EU was published in the official journal of the European Union. Article 14 of the Directive advises that the manufacturer may choose to restrict the application of the EU-type examination (Annex III) procedure to some aspects of the essential requirements, providing that other aspect of the essential requirements the Internal Production Control (Annex II) procedure is applied.
What will mitigate the risk?
If the manufacturer identifies a hazard that is not covered, the next step is to ask what action is necessary to mitigate the risk. This means either looking at other standards for an appropriate test that can be adapted or designing a completely new test suitable for the product. This additional testing can then be recorded in the technical documentation, also called a Technical File, which sits alongside and supports the EU Declaration of Conformity.
It is important to remember that the Directive is non-technical so, in the case of EMC, the requirement is that equipment shall be so designed and manufactured, having regard to the state of the art, to ensure that:
a) the electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended;
b) it has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use.
Harmonized standards are a convenient way to support this, but it is possible to comply with a harmonized standard and still fail to meet the essential requirements of the Directive. The large amount of flexibility and autonomy are given to the manufacturer, including the ability to use their own tests to demonstrate compliance, means a thorough risk assessment is essential.
Manufacturers need to fully review and understand the product’s intended operating environment, considering both the end-user performance requirements and the electromagnetic environment to determine the appropriate tests and limits. Only by assessing these factors is it possible to identify the right tests to ensure the product is fit for purpose.
Consider potential use and misuse of the product
When evaluating the intended EMC environment, it is essential to consider the potential use and the potential misuse of the product. For example, harmonized standards usually assume a certain electromagnetic environment, such as household, industrial, or medical.
It may be assumed, for example, that a laptop is going to be used in a home or office environment. However, if the end-user decides to use it somewhere else (for example, on a train) or in a different way than intended (such as a diagnostic tool in a factory setting) then the EMC environment will be very different and supplementary or increased levels of testing should be considered.
What might the product interfere with? What might interfere with the product? Tests that will answer these questions are often carried out in-house at other stages of the design and manufacturing process. Still, it is vital that the manufacturer understands how to apply and use these tests to comply with the Directive, seeking expert help if necessary.
It is also critical to consider what other non-EMC testing might be necessary. Remember, the Directive is about functionality. It does not assess safety, including electromagnetic safety. This is covered by other CE Marking directives such as the Low Voltage, Machinery Safety, and Medical Devices directives.
Adding wireless functionality to a product will add a further dimension to the testing process, as the product is now officially considered ‘radio equipment’ and must be treated accordingly. Compliance needs to be demonstrated to the Radio Equipment Directive (RED) rather than the EMC Directive 2014/30/EU, with radio standards taking precedence and making testing more complex.
Element can help design a test suite to include a combination of directives or other industry-specified tests. In addition to legislative testing, manufacturers frequently need to comply with additional contractual EMC testing by the automotive, defense, and aerospace industries. Our EMC technical experts provide EMC testing and qualification services for a wide range of industry-specific specifications.
Consider EMC testing to the EMC Directive 2014/30/EU as early as possible in the development cycle
The most cost-effective approach to EMC testing and certification is always to consider it as early as possible in the development cycle. Additionally, combining the tests into a single program can also provide significant benefits to the manufacturer, reducing time and cost and enabling the product to reach the market more rapidly.
If you would like to learn more about Electromagnetic Compatibility (EMC) testing requirements, please get in touch with Element today.
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