The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. The letters ‘CE’ are an abbreviation of Conformité Européenne, French word for European conformity. The CE mark must be affixed to a product if it falls under the scope of ‘New Approach’ Directives of European union.
Without the CE marking, and thus without complying with the provisions of the Directives, the product may not be placed in the market or put into service in the fifteen member states of the European Union and Norway, Iceland and Liechtenstein. However, if the product meets the provisions of the applicable European Directives, and the CE mark is affixed to a product, these countries may not prohibit, restrict or impede the placing in the market or putting into service of the product.
The CE Mark is compulsory within the context of the application of EC New Approach Directives. Thus, CE marking can, be regarded as the product’s ‘trade passport’ for Europe.
Notified bodies are recognized organizations within Member States, which can certify conformity assessment on the basis of the New Approach Directives.
KEY DIRECTIVES
Machinery Safety – 98/37/EEC
All Machines in the European Economic Area (EEA) from January 1st 1995 must comply with the Machinery Directive and be safe. Also all components which are supplied separately to fulfill a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.
EMC – 2004/108/EC
The EMC Directive applies to apparatus liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.
Low Voltage Equipment – 2006/95/EC
The Low Voltage Directive applies to all electrical equipment designed for use with a voltage rating between 50 and 1,000v for alternating current and between 75V and 1,500V for direct current. These voltage criteria define the scope of the directive rather than the limit at which you start applying the regulations (e.g. hazards in 12Vdc circuits of a 240Vac supplied computer are covered under the LVD).
Pressure Equipment – 97/23/EC
This directive covers equipments which affects equipment operating at a pressure greater than 0.5 bars, entered into force and is mandatory from May 2002.
Medical Devices General – 93/42/EEC
All medical products marketed in European Union must carry the CE Marking under Medical Device directive. There are essential requirements in the MDD (such as safety, efficacy and EMC), and products must meet all applicable requirements.
Construction Products Directive – 89/106/EEC
Construction Product means any products, which is produced for incorporation in a permanent manner in construction works, including both building and civil engineering works.
TL 9000 defines the quality management system (QMS) requirements for design, development, production and service provision for the Information and Communication Technologies (ICT) industry.
The TL 9000 standard was developed by and for the ICT industry in 1999 to drive consistency in the quality of products and services down the supply chain through the implementation of a common body of QMS requirements (built on top of ISO 9001) and defined performance-based measurements.
The expected benefits include improved organizational performance, overall cost reduction, increased competitiveness, enhanced customer-organization-supplier relationships, and continual improvement of products and services.
“Safety integrity level (SIL) is defined as a relative level of risk-reduction provided by a safety function, or to specify a target level of risk reduction. In simple terms, SIL is a measurement of performance required for a safety instrumented function (SIF).”
With certification requirements for industrial fire and gas detection (especially in Europe with the introduction of the ATEX standard concerning Safety Related Devices) now including product measurement and physical performances, the ability of the product to carry out its safety function when called to do so is becoming increasingly important.
The IEC 61508 standard (Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems) has introduced a risk-based approach for determining the SIL of safety instrumented functions with a complete approach to quantifying the safety performance of electrical control systems, including the design concept, the management of the design process, operations, and the maintenance of the system throughout its lifecycle.
While IEC 61508 provides the general framework, for gas detection equipment the relevant standard is EN50402:2005+A1:2008 Electrical apparatus for the detection and measurement of combustible or toxic gases or vapours or of Oxygen. Requirements on the functional safety of fixed gas detection systems.
ATEX certification is given to equipment that has gone through rigorous testing outlined by European Union directives. Products that are ATEX compliant have been proved safe to use in specific environments with explosive atmospheres, according to the zone/s they are certified to be used in.
The European Union has mandated that ATEX compliance is necessary wherever a potentially explosive atmosphere exists in order to keep workers safe. These atmospheres are characterized by possessing three things.
Products that have received ATEX certification will have the official “Ex” badge, indicating they are safe in explosive atmospheres.
Non-ATEX/IECEx safe computing devices used in hazardous areas could be an ignition source, so it is critical that ATEX/IECEx certified computing devices are used in those areas. If they are not, the situation immediately poses great risk to workers’ safety. That’s why we’ve built rugged computing devices that are ATEX/IECEx certified.
Similar to ATEX certification, IECEx certification is given to products that have been thoroughly tested and proven to work safely in environments with explosive atmospheres.
IECEx certification is an internationally accepted method that demonstrates compliance with IEC (International Electrotechnical Commission) standards. IEC standards and assessments are recognized internationally as a benchmark for fields of electrotechnology.
To protect the businesses from fraud and ensure that products are free from defects that may affect the health and safety of consumers SASO requires a two-stage certification process to export products into the Kingdom of Saudi Arabia:
IEC stands for International Electrotechnical Commission. IEC provides a standardized approach to testing and certification. IEC testing brings together the agreed-upon set of rules, specifications, and terminology that allow manufacturers to have their devices tested for conformity. Testing a product or device to a Standard then allows that one assessment to provide access to several markets. F2 is able to verify that a product or system conforms to IEC International Standards. F2 specializes in the testing and certification that are required to bring a product to market.
F2 Labs can assist you in testing your electrical products to the applicable IEC standards. The IEC is the world’s leading organization for the preparation and publication of International Standards for all electrical, electronic, and related technologies.
ISO 9001:2015 (QMS), ISO 14001:2015 (EMS), ISO 22000/HACCP, ISO 27001 (ISMS), ISO 13485:2016 (Medical Devices), ISO 45001:2018 (OHSAS), ISO 20000, ISO 50001, CE Marking (European Conformity), ROHS, GMP/WHO-GMP, Lead Auditor, FSSAI, startup, trademark, industrial licence, TS 16949(IATF), IEC CODE etc.
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