Most major electronics manufacturers are concerned with the marketing of consumer, commercial, medical, or light industrial products in the European Union (EU). To apply the CE mark, the EU’s directives outline requirements for regulatory compliance for most electronic products.
CE stands for Conformité Européenne (French), or European Conformity in English. The foreword to CE Marking, The New European Legislation for Products, by Kluwer Business Information, states in bold as a first paragraph:
“The CE Marking offers great advantages to trade and industry in the United States. The new European legislation has created a uniform market within Europe. Up to now, American manufacturers and exporters have had to deal with various sets of national legislation within Europe. Thanks to the introduction of CE Marking, the trade constraints between Member States of the European Economic Area (EEA) have disappeared. The CE Marking forms, as it were, the “trade passport” for products within the EEA.”
CE testing is primarily EMC and Safety related, with the protection of the public and consumers being a primary concern. Harmonization with related national regulations is also a key objective to reduce regulatory barriers between European countries, and to facilitate the movement of goods between them.
To satisfy the CE Mark through CE testing, a manufacturer must meet the requirements outlined by the applicable CE Directives such as EMC (2014/30/EU), Low Voltage (2014/35/EU), and/or Radio Equipment (2014/53/EU) Directives. Each directive specifies a set of harmonized standards that the product will be tested to, and passing the testing outlined in the standards demonstrates that the product is in compliance to the applicable CE Directive. CE Directives are organized product category. The full list of CE Directives can be found here.
The EMC and RED Directives set the essential requirements for all electronic equipment that may interfere with other equipment or that may be interfered with by other equipment; specifically concerning unintentional and intentional generation, propagation and reception of electromagnetic energy which may cause unwanted effects and even physical damage in operational equipment. The goal of EMC is the correct operation of numerous and diverse equipment in a common electromagnetic environment. In other words, a device is deemed electromagnetically compatible when during its normal and intended use it does not interfere with neighboring devices’ operation, nor does it fail to function when in proximity with various ambient electromagnetic phenomena that can be reasonably expected.
EMC comprises two primary categories, Emission and Susceptibility (Immunity). Emissions is the generation of electromagnetic energy, be it deliberate or accidental, by electronic or electrical equipment into the environment. Susceptibility is the tendency of electrical equipment, referred to as the victim, to malfunction or break down in the presence of emissions, which are known as radio frequency interference (RFI). Immunity is the opposite of susceptibility, being the ability of equipment to function correctly in the presence of RFI, with the discipline of “hardening” equipment being known equally as susceptibility or immunity. Both emissions and immunity are of particular concern to medical, communications, and other critical equipment. The directive states, “The result must be a device that cannot be disturbed by electromagnetic interference and that in itself limits the generation of interference in such a way that the other equipment is not disturbed by it. Moreover, the free movement within the European Union of products complying with the EMC Directive must be safeguarded.”
EMC studies emissions and immunity, and the countermeasures or mitigation which may be taken in order to reduce unwanted emissions and continued operation in their presence. This may be achieved by addressing any or all of these issues, i.e., quieting the sources of interference, inhibiting coupling paths and/or hardening the potential victims. In practice, many engineering techniques are used, such as grounding, shielding, signal filtering or suppression and other circuit design considerations.
For product Safety, the protection of the users, and the prevention of injury due to use, misuse, or abuse must be handled with due care. These steps require formalized recordkeeping, information dissemination, and optimized design practice respecting appropriate standards and regulations. Such due diligence involves the cognizance, evaluation, and optimization of health, safety, human, durability, regulatory, and environmental factors using accepted methods, guidelines, and laws.
The Low Voltage Directive (LVD) (2014/35/EU) sets the requirements for electrical safety of electro-mechanical products. The objective of the LVD is to ensure that marketed electronic devices do not jeopardize the safety of persons, domestic animals and goods. Low voltage for the purposes of this directive is defined in Article 1 as any electrical equipment designed for use with a voltage rating between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current, other than the equipment and the phenomena listed in Annex II. A product has been fabricated according to the rules of good craftsmanship if it complies with the appropriate European harmonized standards.
By satisfying the LVD, RED and EMC Directives the manufacturer can mark the equipment under test (EUT) with the CE Mark. With the European Union representing one of the largest integrated, regulated markets in the world and with continuing pressure on manufacturers to bring products to market quickly, the importance of a regulatory strategy is greater than ever. Such a strategy might encompass early adoption of good EMC and Safety engineering practices during the designing and product specification phase including preliminary product testing and evaluation. CE testing is clearly a priority for all manufacturers.
CTS provides CE Mark testing and compliance testing that covers the LVD, RED, and EMC Directives.
Unintentional emissions and immunity or susceptibility testing is performed in CTS’s anechoic chambers. Additional information on both unintentional emissions testing and immunity or susceptibility testing can be found here.
Upon completion of the testing associated with LVD, RED and EMC Directives a manufacturer can mark the device with the CE Mark allowing sale of the equipment within the European Union.
Please contact CTS to start a quote for European CE Mark compliance. Additionally, you can start the process by requesting a quote.
Safety Requirements
Companies planning to sell electronics in Europe are required to have products tested against the applicable product Safety standard. These standards protect users from potential threats such as excessive heat, electrical shock, and mechanical failure. In Europe, many electronic devices are required to pass such testing before they can be sold to the public. Safety testing is performed in controlled lab environments by test engineers who use specialized equipment to poke, prod, burn, and impede devices to confirm that they can be safely operated by the public.
Safety testing covers thermal, electrical, and mechanical risk areas. For an electronic device to pass testing it must:
- Remain at a safe operating temperature to avoid injury or accidental flame
- Have sufficient insulation to avoid user shock
- Demonstrate that it is mechanically sound
CTS can test to the following CE mark safety standards:
- IEC/EN 60601-1 Medical Electrical Equipment
- IEC/EN 61010-1 Measurement, Control and Laboratory Equipment
- IEC/EN 62368-1 Audio/Video and Information Technology Equipment
- IEC/EN 60529 Degrees of protection provided by enclosures (IP Code)
- IEC/EN 60950-1 Information Technology Equipment (Remote Feeding, equipment installed outdoors, large data storage)