Europe
· CE
CE(Conformité Européenne) certification is a regulatory standard that certifies certain products can be safely sold and used in the European Economic Area (EEA). Manufacturers put the CE mark on their certified products to show its compliance to European safety regulations which can be traded freely within the EEA.
It is also called a harmonized standard (European standard) developed by European Standards Organisations: CEN, CENELEC, or ETSI which were created by a request from the European Commission. Manufacturers, other economic operators, or conformity assessment bodies can use harmonized standards to demonstrate that their products, services, or processes comply with relevant EU legislation.
The references of harmonized standards must be published in the Official Journal of the European Union (OJEU) to be widely used as a reference.
Unlike other certification marks, the CE marking is not issued by a specific regulatory body, but may be subject to an independent conformity assessment by a Notified Body to ensure that certain products are qualified for the CE requirements and evaluation. Ultimately, manufacturers are responsible for the proper use of the CE marking and is only obligatory for those which EU specifications indicate and require the affixment of the mark.
· What does it mean?
Affixing the CE Mark indicates that the product or the manufacturer qualifies European Standards such as Safety, Health, Environment, Consumer Protection. In other words, fullfills all EC Regulations or Essential Requirements of Directives.
โปCE marking serves as a trading passport in the European market, allowing manufacturers to freely distribute their certified products in the EEA countries. It replaces previous national regulations with a unified set of conformity and eliminates the need to adapt products to the specific requirements of each individual EEA member state. In short, CE marking connotes the meaning of compliance requirements for manufacturers' duty of sales and imports of products into the EU market.
· Member States of the CE Marking
Austria, Belgium, Bulgaria, Cyprus, Czech Repubplic
Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Repubplic of Ireland,
Romania, Slovakia, Slovenia, Spain, Sweden (26 Countries)
EFTA
Norway, Liechtenstein,
Switzerland, Iceland
Commercial Standardisation
๏ผCEN: European Committee for Standardization
๏ผCENELEC: European Committee for Electrotechnical Standardization
๏ผETSI: European Telecommunications Standards Institute
· CE Certification
CE Certification | |||
Target Items | |||
Medical devices | Active Implantable Medical Devices | In vitro Diagnostic Medical Devices | Consruction Products |
Machinery | Electrical Equipment | Electronic Equipment | Pressure Equipement |
Simple Pressure Vessels | Gas Appliances | Radio and Telecom Terminal Equipment | Lifts |
Calbeways | Equipment and Protective System for use in explosive atmospheres | Explosive for civile use | New hot water boilers |
Measuring Equipment | Non-automatic weighing instruments | Toys | Recreational Craft |
· CE Directive
Directive | Directive Title | Target Itmes | EC Directive | Time in Force |
LVD | Low Voltage Directive | Covers health and safety risks on electrical equipment operating with an input or output voltage of between AC 50 ~ 1000 V, DC 75 ~ 1500 V (household appliances, cables, power supply units, laser equipment, certain components, e.g.. fuses) | 2014/35/EU | 2016.04.20 |
EMCD | Electromagnetic Compatibility Directive | Applies to all electrical, electronic or electrical components sold in the European Union for the purpose of preventing malfunction of equipment against electromagnetic interference, protecting the radio environment, and strengthening resistance to external electromagnetic impacts. | 2014/30/EU | 2016.04.20 |
RED | Radio Equipment Directive | It is a direct/indirect guideline for wireless communication terminal equipment. It is a product that is freely sold without any constraint of movement and serviced in the EU market as a communication device which transmits and receives wireless signals. *R&TTE Directive (1999/5/EC) was replaced to RED as of April 13, 2016. | 2014/53/EU | 2016.04.13 |
· EMCD(Electromagnetic Compatibility Directive)
Overview
All electrical devices or installations affect each other when connected or in close proximity to each other. Interference between TVs, GSM handsets, radios and nearby washing machines or power lines. The purpose of electromagnetic compatibility (EMC) is to properly control all these side effects. EMC refers to all existing and future techniques for reducing interference and enhancing immunity.
The electromagnetic compatibility (EMC) Directive 2014/30/EU ensures that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance.
EMC Directive |
Target CategoExempteries |
· Industrial Manufacturing Machines · Portable Radio Devices · Radio Telecommunication Devices· Medical/Scientific Equipments · IT Equipments · Electronic Household Appliances · Aviation/Maritime Radio Devices · Educational Devices · Network Related Devices · Radio/Television Sets · Radio/Television Transmitters · Lights/Fluorescent Lgithse |
Testing Categories |
EMI(Electromagnetic Interference) |
· Condudcted Emission · Radiated Emission |
CE· EMC Process
Applicable Standards | Low Voltage Standards |
· EN 300 220 · EN 300 328 · EN 300 330 · EN 300 440 | · EN 62368-1 ITE Devcies (EN 60950-1) |
EMC Standards | RF Standards |
· EN 301 489 - Series | · Portable Devices Used Wihtin 20 cm are required for SAR(Specific Absorption Rate) Tests · Fixed or Devices Used Over 20 cm are required for MPE(Maximum Permissible Exposure) (EN 62311) |
· RED(Radio Equipment Directive)
Overview
It is obligatory for all manufacturers/distributers of radio devices to qualify RED Directives
Radio equipment manufacturers/sistributers who wish to enter the EU market shall comply with radio equipment directive (RED) and affixation of the CE mark.
Target Itmes | Technical Documents |
1) Radio Communication Apparatus(under 3,00GHz) 2) WSN(RFID, Radar, etc.) 3) Broadcast Receivers | · Application Documnets · User's Manual · Product Manual · Parts Layout Drawings · Parts Lists · Circuit Digrams PCB Layouts · Antenna Gain Patterns · Block Diagrams · Zigbee Information |
RED Flow Chart
· RoHS (Restriction of the use of Hazardous Substances in Electrical and Electronic Equipment) Directive
Overview
The rise in the production and use of electrical and electronic products, such as mobile phones, computers and kitchen appliances, has resulted in an increasing volume of electrical and electronic waste. During the use, collection, treatment and disposal of such waste, products may release harmful (hazardous) substances such as lead, mercury and cadmium, which can cause major environmental and health problems.
To address such challenges, EU laws restrict the use of certain hazardous substances in electrical and electronic equipment through the RoHS Directive. In parallel, the WEEE Directive promotes the collection and recycling of such equipment.
The RoHS Directive currently restricts the use of ten substances: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).
All products with an electrical and electronic component, unless specifically excluded, have to comply with these restrictions.
In 2017, the Commission adopted a legislative proposal adjusting the scope of the RoHS Directive.
The RoHS Directive aims to prevent the risks posed to human health and the environment related to the management of electronic and electrical waste.
It does this by restricting the use of certain hazardous substances in EEE that can be substituted by safer alternatives. These restricted substances include heavy metals, flame retardants or plasticizers.
The Directive promotes the recyclability of EEE, as EEE and its components that have become waste contain fewer hazardous substances. At the same time, it ensures a level playing field for manufacturers and importers of EEE in the European market.
Target Items | 1) Large Household Appliances 2) Small Household Appliances 3) Communications/Computing Devices 4) Consumer Electronics 5) Lighting Equipments 6) Power Tools 7) Toys, Leisure/Sports Equipment 8) Medical Devices/Equipment 9) Monitoring/Control Equipment 10) Automatic Dispensers 11) Miscellaneous Types of Electronic/Electrical Equipment |
Exempted Items | 1) Military/Security Equipment 2) Designed to be sent into Space 3) Part of non-scope Equipment 4) Large-scale Stationary Industrial Tools 5) Large-scale Fixed Installations 6) Means of Transport 7) Non-road Mobile Machinery 8) Active Implantable Medical Devices 9) Photovoltaic Panels 10) R&D Equipment |
RoHS Restricted Substances | Reference |
· Lead | < 0.1% |
· Mercury | < 0.1% |
· Cardimium | < 0.01% |
· Chromium VI | < 0.1% |
· PBB; Polybrominated biphenyls | < 0.1% |
· PBDE; Polybrominated diphenyl ethers | < 0.1% |
· DEHP; Bis(2-ethylhexyl) phthalate | < 0.1% |
· BBP; Benzyl butyl phthalate | < 0.1% |
· DBP; Dibutyl phthalate | < 0.1% |
·DIBP; Diisobutyl phthalate | < 0.1% |
· WEEE(Waste Electrical and Electronic Equipment) Directive
Overview
WEEE compliance is intended to encourage the design of electronic products for environmentally safe recycling and reuse. RoHS compliance aligns with WEEE by reducing the amount of hazardous chemicals used in electronics manufacturing. RoHS regulates hazardous substances used in the manufacturing process of electrical and electronic equipment (EEE), and WEEE regulates the disposal of that equipment. All products applicable to the EU market must be WEEE compliant and bear the Wheelie Bin mark. Therefore, EEE manufacturers must successfully comply with RoHS and WEEE regulations. Previously, WEEE was intended for specific devices only. As of August 15, 2018, the scope of WEEE has been expanded to include all EEE classified under six categories instead of the existing 11 RoHS product categories. All batteries contained in WEEE are also collected according to the WEEE Directive. However, according to Annex VII of the WEEE Directive, after recovery (either by manual, mechanical, chemical or metallurgical treatment), batteries must be removed from the product and counted towards the recovery target of the separate EU Battery Directive. there is. It is also subject to the recycling requirements of the Battery Directive.
โป Product Categories
* The WEEE Directive is a guideline for environmental conservation, and each member state enacts and implements its own laws, which could be stricter than the guidelines.
* The scope of the target product in the Directive is comprehensive, and different interpretations are possible when drafted in the Member States.
Therefore, the products included in the regulation may vary.
5 Items Exempted from WEEE | - Military, Space, Transportation, R&D, Non-Road Mobile Machinery, Large-Scale Fixed Installations, Lrage-Scale Stationary Industrial Tools, Active Implantable Medical Devices, Sub-Equipment for Out-of-Scope Equipment, Compact Flourescent Light Bulbs/Lamps |
· ErP(Energy Related Products) Directive
Overview
The ErP (Energy Related Products) Directive is a revision of the existing Eup Directive and is designed to protect the EU's environment by regulating the use of energy-using products and minimizing the impact of environmental pollution.
The ErP Directive (2009/125/EC) is a 'Green Design Directive' that applies to most products that consume energy during the life cycle, such as home appliances, and aims to minimize energy use at all stages of product design, production, transport, packaging, and to provide consumers with more energy-efficient products.
Product testing is accompanied by demonstration of energy consumption below the agreed level during ErP certification. Once the test is complete, the product can be CE-marked and can be sold throughout the EU.
When obtaining a CE mark, all eligible items must satisfy ErP at the same time, so it should be noted that having a CE mark means meeting the energy efficiency guidelines, and that entry into the EU will be prohibited if the requirements are not met.
Items Subject to ErP |
Washing Machines/Dryers · Air Conditioners/Fans · Electric Displays/TV Boxes · Computers/Servers · Video Equipments · Gaming Consoles · Kitchen Appliances · Lighting Devices · Heaters · Freezers · Vaccum Cleaners · Pumps · Transformers/Converters · Electric Motors · Tires · Welding Machines · Off Mode, Standby/Network Standby Mode |