Approvals, certifications and guidelines
Country approvals: European Union
CE stands for “Conformité Européenne” and is a declaration by the manufacturer or distributor that the product complies with the applicable requirements. This marking is required for the introduction of goods into the European Economic Area. To prove conformity, various directives / regulations must be complied with. These vary depending on the device, e.g. 2014/35/EU for electrical equipment, also known as the Low Voltage Directive, or 2014/31/EU for electromagnetic compatibility. These directives in turn refer to specific harmonised standards which must be complied with. They must be listed in the CE declaration. Only when these requirements are met is it permitted to affix the familiar CE symbol.
Low Voltage Directive
One of the relevant directives is the Low Voltage Directive 2014/35/EU. For devices in the field of audio, video, information and telecommunications, EN62368-1 must be fulfilled. The focus here is on the protection of persons and property; it is checked whether sufficient safety measures have been taken so that the device can be operated without danger. The standard lists electrical energy, thermal energy, mechanical energy, temperature, radiation and chemical hazards as possible sources of danger.
The 2014/31/EU represents the directive for electromagnetic compatibility. The aim of this directive and the associated harmonised standards is to ensure that devices do not interfere with each other. This is tested by measuring the electromagnetic waves emitted by the device. In addition to radiation, some standards also address sensitivity. This is to ensure that devices do not experience any adverse effects when they are exposed to low levels of electromagnetic radiation.
Radio Equipment Directive (RED)
The Radio Equipment Directive 2014/53/EU is the most important directive for electronic equipment, along with the Low Voltage Directive and the Electromagnetic Compatibility Directive. It applies to all devices that have a radio interface, including Bluetooth, WLAN, and all mobile phone standards. It serves to protect health and safety. This is achieved by measuring electromagnetic compatibility, ensuring maximum radiation emission, and avoiding radio interference.
RoHS is an abbreviation and stands for “Restriction of (the use of certain) Hazardous Substances in electrical and electronic Equipment”. The exact definition can be found in the EU Directive 2002/95/EC. To import electrical or electronic equipment into the European Economic Zone or to distribute it there, it is necessary to prove that certain substances only occur in quantities that do not pose a risk to humans or the environment. In 2021, the following substances are currently listed there:
- Hexavalent chromium
- Polybrominated biphenyls
- Polybrominated diphenyl ethers
- Bis(2-ethylhexyl) phthalate
- Benzyl butyl phthalate
- Dibutyl phthalate
- Diisobutyl phthalate
The list of substances which may only be present in small quantities is updated regularly, most recently on 31.03.2015.
The REACH regulation is designed to protect human health and the environment from risks posed by chemicals. Unlike RoHS, REACH applies to all products, substances, articles, and chemicals and not exclusively to electrical or electronic equipment. As of October 2021, the list includes 219 SVHC (Substances of Very High Concern). This list is revised every six months by the European Chemicals Agency (ECHA). The aim of REACH is to reduce the substances of very high concern in the long term and to replace them with health or environmentally friendly alternatives. The current list of substances of very high concern can be viewed directly at ECHA.
Another possibility of product authorisation for the European Economic Area is type approval. Type testing is only possible through notified bodies. For the customer, a type of examination is indicated by the CE symbol with an appended check digit of the notified body.