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DO I Need CE Marking?

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Sadly, the process of determining whether the CE marking applies to a product or not is complex. The European legislator does not furnish any list of products or nomenclatures that can be used to identify the relevant CE marking directives.

The CE marking is applicable on the products put into service or placed in the market in the European Economic Area (EEA), and only for certain product groups or product aspects. Therefore, for the purpose of answering the question of whether a product needs to be CE marked, one first needs to determine in which countries the products are going to be used or placed in the market. Secondly, for each single directive, it has to be determined if the products, or some of its aspects, fall within its scope.

Step 1. In which countries the products are going to be placed in the market or used?

The CE marking is required only in the member countries of the European Economic Area (EEA). EEA is composed of twenty-eight member states of the European Union (EU):

  1. Austria
  2. Belgium (Founder Member in 1957)
  3. Bulgaria
  4. Croatia
  5. Cyprus
  6. Czech Republic
  7. Denmark
  8. Estonia
  9. Finland
  10. France (Founder Member in 1957)
  11. Germany (Founder Member in 1957)
  12. Greece
  13. Hungary
  14. Ireland
  15. Italy (Founder Member in 1957)
  16. Latvia
  17. Lithuania
  18. Luxembourg (Founder Member in 1957)
  19. Malta
  20. The Netherlands (Founder Member in 1957)
  21. Poland
  22. Portugal
  23. Romania
  24. Slovakia
  25. Slovenia
  26. Spain
  27. Sweden
  28. United Kingdom (Great Britain)

Also, there are three members of the European Free Trade Association (EFTA):

  • Iceland
  • Norway
  • Liechtenstein

Though Switzerland is member of the EFTA, it is not a part of the EEA.

An important point to note here is that, Turkey is neither a part of the EEA nor is considered a member of the EU. However, Turkey has fully implemented many of the European CE marking directives. This means that for many products, Turkey also require CE Marking.

If the product is to be put into service or placed in the markets mentioned above, the CE mark needs to be applied if the product is covered by one or more of the European CE marking directives.

  1. What are the directives in which the product falls?

The CE marking is essential for the products for which a CE marking directive or regulation has been established. There are directives/regulations for the following types of products. There can be more than one directive/regulation that can apply to a single product. The directives for CE Marking are:

  • Toys
  • Machinery
  • Electrical equipment
  • Electronic equipment
  • Personal protective equipment
  • Pressure equipment
  • Medical devices
  • Active implantable medical devices
  • In vitro diagnostics
  • Radio and Telecommunications terminal equipment
  • Simple pressure vessels
  • Gas appliances
  • Lifts
  • Recreational craft
  • Equipment and protective systems for use in explosive atmospheres
  • Non-automatic weighing instruments
  • Cableways
  • Construction products
  • Explosives for civil use
  • New hot water boilers
  • Measuring Equipment

The CE mark is NOT required for the following products:

  • Chemicals
  • Pharmaceuticals
  • Cosmetics
  • Foodstuffs

Products not covered by the European CE marking directives, might fall within the scope of other European or national legislation. But if there is no specific legislation, the General Product Safety Directive (2001/95/EC) may apply. This European Directives demands that the products are safe, but is does not require any marking.

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Steps to Get CE Certification

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The member countries of the European Union (EU) take for granted that the products bearing the CE mark comply with all the provisions of the applicable directives. Consequently, the placing of the products bearing the CE Mark in the market shall not be prevented, restricted, or prohibited until and unless the provisions relating to the CE marking are enforced incorrectly.

Products covered under the New Approach Directives have the CE Marking. The CE Mark therefore implies that the products comply with the essential requirements of the relevant directives and that they are subject to the conformity assessment processes specified in those directives. On this basis, the member countries of the European Union are obligated to take adequate measures to protect the CE marking.

The New Approach directives are applicable to the products intended to be offered to consumers for the first time within the EU. In general, these products are either ready-to-use or require adjustments that can only be made for their intended use. In brief, the directives are applicable on new products manufactured in EU member countries and on the new products imported from third countries or second hand products. The concept of product varies among the New Approach directives. For example, the directives include, accessories or systems, materials, equipment, assemblies, apparatus, components or safety components, devices, tools etc. Thus, the manufacturer must check if a product is covered by more than one directives.

Products which are subject to significant changes are treated as new products and they must comply with the provisions of the respective directives before being presented in the markets of European Union countries. Products which have been refurbished without altering their original shape, performance and intended use are not subject to conformity assessments as per the New Approach directives.

The basic requirements outlined by the New Approach directives may complement or overlap each other, subject to the hazards covered by those conditions associated with the product up for discussion. Where the same product or hazard falls within the scope of more than one directives, the application of other directives can sometimes be excluded by performing a risk analysis of the intended use of the product that is defined by the manufacturer.

Manufacturers outside or within the EU are liable for affixing the CE Mark on the products covered by the New Approach Directives. In general, there are 6 steps to CE certification process:

  1. Identifying the directives or directives to which the product applies. The first step is to determine which directives the product falls under.
  2. Identify the requirements of the directive(s) for the product. Each directive details out what is legally required for product compliance.
  3. Determine the need for third-party assessment. Some directives require that products be tested and approved by a third-party organization to ensure compliance with the applicable basic requirements.
  4. Evaluation of product suitability. The directives consist eight conformity assessment modules. These modules are applicable to a specific product category and are identified as follows:
    • Module A Internal production control,
    • Module B European Union type examination,
    • Module C Type compliance,
    • Module D Production quality assurance,
    • Module E Product quality assurance,
    • Module F Product verification,
    • Module G Unit verification and,
    • Module H Full quality assurance.
  5. Preparing and storing technical files. Producers are required to create a technical dossier containing documents and information indicating that the product complies with the directive requirements and keep it for a minimum period of 10 years from the date of manufacture.
  6. Making a declaration of conformity and affixing the CE mark. The declaration of conformity proves that the product complies with the mandatory safety requirements and is established on the basis of technical file.

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CE for Hot Water Boilers

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Hot water boilers used in commercial and homes spaces for heating purposes serve as an important part of overall energy consumption in Europe. Therefore ensuring that they meet the stringent energy efficiency requirements is of great importance in the light of the EU’s commitment to increase overall energy efficiency. Improved boiler efficiency is also in the interests of consumers in terms of reducing fuel costs. Thus, for placing the hot water boilers in the EU market, the manufacturer needs to make sure that it is CE marked. The presence of the CE marking on these boilers indicates that they fulfill the harmonized requirements set in place to allow them to be sold any-where in the European Economic Area (i.e. made up of the EU countries plus Norway, Iceland and Liechtenstein) as well as in Turkey.

Finding the relevant European Harmonized standards

The first step that manufacturers have to take to ensure that their boiler will be compliant with the Directive is to confirm which European Harmonized standards are applicable. This can be done with the help of the relevant page of the European Commission’s Enterprise and Industry website.

CE marking and the Directive on Hot-Water Boilers

Hot Water Boilers Directive 92/42/EEC is intended to ensure that the new hot-water boilers fired with gaseous or liquid fuels offer a high level of energy efficiency and also harmonize the rules regulating the sale of such boilers within the EU. Article 5 of the Directive lays down the energy efficiency requirements to be complied with, both at part load and at rated output.

It is the legal responsibility of the manufacturers of hot water boilers to verify the compliance of their product with this directive before placing the CE mark on it, and selling it in the European Economic Area, by having a Notified Body certify conformity to the directive. This includes having a proper documentary evidence (i.e. test reports, etc.) and proper product design to show that the product complies with all relevant criteria in the directive 92/42/EEC.

Where can I find the legal texts and explanatory information?

The Directive can be downloaded from the relevant section of the EU’s Europa website, where some explanatory information can also be found.

Conformity Assessment for CE Marking

Conformity assessment for boilers comprises of two steps:

  • Analyzing the efficiency of a boiler type in accordance with module B (described in Annex III of the Directive)
  • Completing the declaration of conformity to the approved type in accordance with module C, D or E (described in Annex IV of the Directive)

For boilers burning gaseous fuels, conformity assessment procedures are the same as those laid down in the Gas Appliances Directive 2009/142/EC, namely:

  • First is, the EC-type examination by a Notified Body, the details of which are explained in point 1 of Annex II of Directive 2009/142/EC.
  • Second is, completion by the manufacturer of one of three EC declaration of conformity to type procedures, or of the EC verification procedure, details of which are provided in points 2-5 of Annex II of Directive 2009/142/EC.

Each appliance placed on the market must bear the CE marking and must come along with the EC Declaration of Conformity signed by the manufacturer. The manufacturer must affix the CE marking on the boiler in an easily legible, visible and indelible manner.

We at Eurotech provide CE Certification Services for hot water boilers. With the help of our services, enterprises are able to produce more efficient, high performing and quality products in a fast, safe and uninterrupted manner.

CE Certification of hot water boilers is only one of the certifications provided by our organization.Many other certification services like CE Certification for medical devices, electrical/electronics, pressure equipment, RoHS etc. are also available.

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CE for Personal Protective Equipment

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Personal protective equipment refers to the equipment that safeguards employees against safety and health risks at work. It is the responsibility of employers to ensure the use and supply of this equipment in the employee’s work environment. Major Personal Protective Equipment (PPE) comprises of materials such as eye protection, safety shoes, safety helmets, safety belts, gloves and high visibility clothing.

Training studies, procedures, implementation instructions and inspections provided to make safe work environments and encourage employees to work responsibly and safely are essential elements for personal protection. Even where safe work systems and engineering controls are implemented, not all hazards can be prevented. The main health risks to employees are:

  • Skin disorders due to contact with abrasive substances
  • Head and foot injuries due to falling materials
  • Lung diseases due to breathing dirty air
  • Various body conditions due to exposure to extreme heat or cold air
  • Eye disorders due to flying particles or splashing of corrosive liquids

It is necessary to use PPE to reduce risks and be protected from all these situations.

The primo thing is to take all kinds of preventive measures in working environments against dangers. Requirement of PPE should be a last resort. It must be provided by employers to their employees free of charge if it is still required after finishing the other checks. Personal protective equipment should be chosen discreetly and trained for the correct use by employees.

Personal protective equipment (PPE) directive 2016/425/EU is published in the European Union. In India, the Regulation on the Use of Personal Protective Equipment in the Workplace has been issued by the Department of Health and Social Care. The purpose is to ensure that risks in work environments are averted or mitigated if the risks cannot be avoided. If risks cannot be prevented inspite the measures taken, personal protective equipment is needed. The Regulation sets out the principles for the supply, use and specification of personal protective equipment.

The European Union directive stipulates that all the products falling within the scope of PPE equipment must be CE marked. When selecting personal protective equipment, it has to be ensured that it is CE marked.

PPE is defined in Directive 2016/425 as follows: “Any device or material designed to be worn or held by employees for protection against one or more health and safety hazards. This means that personal protective equipment can be worn or not worn by the employee to perform the protection function. This equipment may not be designed to connect and secure to a reliable point.”

For CE marking application, personal protective equipment can categorized into:

  • Category I: PPE for the protection of workers against the minimum risks as defined in the Annex of the Directive
  • Category II: PPE not covered by Category I or Category III
  • Category III: PPE for the protection of workers from very serious risks like irreversible damage to the health or death as defined in the Annex of the Directive.

For category I, the manufacturer simply has to prepare the test file and place the CE mark on the product. For Category II, the manufacturer has to prepare the technical dossier, carry out tests and affix the CE mark on the product after issuing a declaration of conformity. For Category III, the product has to be factory tested prior to the declaration of conformity.

Our company also provides personal protective equipment CE Certificate services within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.

Personal protective equipment CE Certification services provided within the scope of certification services are only one of the services provided by our organization in this respect. Many other certification services like CE Certification for medical devices, electrical/electronics, pressure equipment, RoHS etc. are also available.

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Engineer’s Responsibility

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For any construction project, the required quality of fabrication or Execution Class (EXC) must be stated. The system of determining the EXC has recently been amended. Now it must be determined according to the requirements of Annex C of BS EN 1993-1-1 and the National Annex associated with it. The Execution Class needs to be specified for:

  • The works as a whole
  • An individual component
  • A detail of a component

The responsibility of the engineer is to specify the Execution Class for the structure (the works as a whole) and for details and components where it is required to specify an Execution Class different to that specified for the structure. Where different, the Execution Class for a detail or component must not be less than that specified for the works as a whole. The EXC for a detail or component should be distinctly identified in the execution specification if it is different to the EXC for the structure. The process to determine the Execution Class for buildings is an easy two-step process:

  1. Determine the Consequences Class: The reason for categorizing the Consequences Class (CC) is to make sure that the buildings are constructed with the appropriate level of quality control within the fabrication process. The CC for a building is derived on the basis of building height (number of storeys), building type, occupancy and floor plan area per storey (for retail). A structure, or a part of it, can also consist of components with different CCs. Table 11 of Approved Document A can be used to ascertain the Consequences Class for a range of building types & occupancy. In Table 11, CC2a and CC2b are subdivisions of CC2 when determining the Execution Class required for a structure.ce for construction
  2. Select the Execution Class: Having determined the Consequences Class for a building, the relevant Execution Class is simply derived from Table NA.4 of the National Annex to BS EN 1993-1-1:2005+A1:2014. For the majority of buildings constructed in the UK, EXC2 will be the appropriate requirement. Where the Consequences Class is not specified, clause NA2.27.2 of the National Annex to BS EN 1993-1-1:2005+A1:2014 states that it should be considered that the design rules in BS EN 1993 are safe for Consequences Classes up to & including CC2. The engineer should always derive the EXC as per the design parameters appropriate to each project. The requirements to each Execution Class are listed in Table A3 of BS EN 1090-2 and can be reviewed by the engineer if needed. However, the engineer should refrain from over-specification of the Execution Class wherever possible to avoid extra costs. For example, EXC2 is the EXC derived for a project but the engineer requires full traceability i.e. an EXC3 requirement in place of the partial traceability requirement of EXC2. Instead of specifying EXC3 on the basis of achieving this single clause requirement, it is advised that EXC2 be still specified but along with the higher level of traceability added to the specification.CE for construction

 

We at Eurotech provide CE Certification Services for construction products. With the help of our services, enterprises are able to produce more efficient, high performing and quality products in a fast, safe and uninterrupted manner. Many other certification services like CE Certification for medical devices, electrical/electronics, pressure equipment, RoHS etc. are also available.

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CE for Fabricated Structural Steelwork

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Construction Products Regulation (CPR) - 305/2011, places legal obligations on the construction supply chain in terms of ‘manufacturers’, ‘importers’ and ‘distributors’ of construction products used within the EU, to CE Mark their products where they are covered by either a harmonized standard or European Technical Assessment (ETA). This not only applies to constituent products (such as steel beams, bolts etc.) but also to fabricated elements and systems made from both non-CE Marked and CE Marked products.

According to the CPR, all the products used in construction have to have CE Mark to show compliance where either a harmonized standard or ETA. All average construction products fall under the harmonized standards and must therefore bear CE Mark. For fabricated structural steelwork, contractors, engineers and steelwork contractors should have altered their specifications accordingly to make sure that only CE Marked products are used on their projects.

The harmonized standard covering fabricated structural steelwork is BS EN 1090: Execution of steel structures and aluminium structures. The standard is divided into 2 parts.

  • Part 1: Requirements for Conformity Assessment of Structural Components: - It explains how manufacturers can display that the components they produce meet the declared performance characteristics (the structural characteristics which make them fit for their specific function and use).
  • Part 2: Technical Requirements for Steel Structures: - It explains the requirements for the execution of steel structures to guarantee adequate levels of mechanical stability and resistance, durability and serviceability. It regulates the performance characteristics for components that the manufacturer must declare and achieve through the requirements of Part 1.

Requirements of CE Marking for Steelwork Contractors:

To be able to CE Mark the fabricated structural steelwork that they produce, steelwork contractors are obligated to declare performance to the System 2+ System of Assessment and Verification of Constancy of Performance (as described in Annex V of the Construction Products Regulation).

For this, they are required to undertake:

  • Initial type-testing of the product
  • Factory Production Control (FPC): It includes:
    • Implementing FPC system procedures
    • Implementing of Welding Quality Management System (WQMS) procedures
    • Appointing a Responsible Welding Coordinator (RWC)
  • Further testing of samples taken at the factory in accordance with the prescribed test plan

They also need to be assessed by a notified body that will carry out:

  • Initial inspection of the FPC
  • Initial inspection of the manufacturing plant
  • Continuous assessment, surveillance and approval of the FPC, which usually includes:
    • An audit so as to ensure continued competence to the declared Execution Class (Table B.3 of BS EN 1090-1 sets out minimum levels for the routine surveillance intervals)

The notified body will then issue an FPC certificate and Welding Certificate identifying the Execution Class that the steelwork contractor has achieved.

We at Eurotech provide CE Certification Services for fabricated structural steelworks. With the help of our services, enterprises are able to produce more efficient, high performing and quality products in a fast, safe and uninterrupted manner.

CE Certification for fabricated steelworks is one of the many certifications provided by our organization. Many other certification services like CE Certification for medical devices, electrical/electronics, construction, pressure equipment, RoHS etc. are also available.

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CE Certification for Pressure Vessels

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According to Pressure Equipment Directive, the term ‘pressure equipment’ includes pressure vessels, safety devices, plumbing pipes and elements attached to pressure parts such as tubules, couplings and flanges.

Importing and manufacturing companies should know whether a notified body is to be involved or the pressure equipment is to be evaluated directly. The PED classifies pressure equipment into 4 categories, on the basis of product characteristics like, the maximum permissible diameter, pressure and volume of the pressure equipment and the state of the desired material content.

In case different categories of pressure equipment are installed in an integrated and functional unit, the pressure equipment of the highest category determines the entire installation. Every module specifies an eligibility process to be followed and the appropriate module is applied according to the applicable category.

By putting the CE Mark on the pressure equipment, the importer or the manufacturer discloses that his product meets the essential requirements of the 2014 / 68 / EU Pressure Equipment Directive. Only those pressure receptacles that are CE marked are free to operate within the European Economic Area.

Devices and parts that contribute in the resistance of pressurized containers are mostly unalloyed aluminum, unalloyed quality steel, or aging hardened aluminum alloys. The products that are not covered by 2014/68/EU are:

  • Pipelines for the transport of any fluid or substance to a facility by land or sea
  • Aerosol dispensers (Directive 75/324/EEC)
  • Pressure equipment consisting of a flexible body (e.g tires and airbags)
  • Bottles or cans used for carbonated drinks
  • Blast furnaces
  • Radiators and pipes in hot water heating
  • Simple pressure vessels (directive 2014/29/EU)

Comprehensive CE Mark Certification for pressure equipment is done by competent authorities in accordance with this regulation. In addition to the CE certification, product classification to determine the relevant requirements, regulatory risk analysis, product conformity testing based on European harmonized standards, selection and guidance for the notified body if necessary, preparation and evaluation of the technical file, preparation and control of user instructions and Services for verifying the European Union declaration of conformity are also provided.

The Pressure Equipment Directive (PED) contains legal obligations for distributors, manufacturers and importers. A technical dossier needs to be prepared by manufacturers for pressure equipment and they need to carry out the conformity assessment process. The EU then declares the conformity of the concerned pressure equipment to the applicable requirements and affix the CE mark on the product.

Safety assessment and product testing based on European harmonized standards has to be carried out while conducting conformity assessment.

We at Eurotech provide CE Certification Services of pressure vessels. With the help of our services, enterprises are able to produce more efficient, high performing and quality products in a fast, safe and uninterrupted manner.

CE Certification of pressure vessels are is only one of the certifications provided by our organization. Many other certification services are also available.

For more information, contact trg@eurotechworld.net or fill out the form below to get your QUOTE today.

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CE Certification for Luminaries

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The CE marked luminaires ensure safety and prove their compliance with the relevant legal regulations.

There are many independent laboratories carrying out independent tests to support the declaration of conformity required by manufacturers to affix CE Mark on lighting fixtures. It is a legal obligation on the part of the importers or manufacturers outside of the European Union countries to take care of the fittings to be offered to consumers.

The declaration of conformity to the following directives is essential for the manufacturers for CE marking their luminaries:

  • Low Voltage Directive - 2014/35/EU
  • Electromagnetic Compatibility Directive 2014/30/EU
  • Radio Equipment Directive 2014/53/EU
  • Energy Related Products Directive 2009/125/EC
  • Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU

 

The following legal regulations were issued based on these directives:

  • Implementing Regulation on Environmentally Friendly Design of Energy Related Products
  • Regulation on Electrical Equipment Designed for Specific Voltage Limits (Low Voltage Regulation)
  • Implementing Regulation on Wireless and Telecommunication Terminal Equipment
  • Implementing Regulation on Classification, Packaging and Labeling of Dangerous Substances and Preparations
  • Electromagnetic Compatibility Regulation

A number of tests required by the luminaries to be affixed with the CE mark, can be carried out by the manufacturers on their own or they can avail the testing services of advanced laboratories. Once the required tests are completed, the manufacturer has to keep the test reports in the technical file.

There are other relevant regulations that may also be applicable in the CE marking process and may require compliance. Example, general product safety regulation, REACH regulation, waste management, batteries, energy labeling.

In many cases, harmonized European standards are adequate to comply with the requirements of legal regulations and offer the easiest means to meet the requirements of manufacturers.

Deviation from standards, like failure to meet full performance requirements, have to be explained in detail in the declaration of conformity and technical dossier as to why the standard is not fully implemented. Such deviations may cause problems with government agencies as it can lead to different interpretations depending on who makes the comment, the solution proposal & the intended use of the product. However, manufacturers should of course only provide suitable products in the market and document that the products meet the basic requirements.

According to the types of commonly used lighting fixtures, the main standards for CE marking conformity are:

  • Regarding low voltage,
    • TS EN 60598 Lighting fixtures
    • TS EN 62493 Inspection of illumination equipment for people exposed to electromagnetic fields
    • TS EN 61347 Lamp control system
    • TS EN 60432 Lamps - Incandescent filament - Safety regulations
  • Regarding electromagnetic compatibility,
    • TS EN 55015 Limit measurement methods and values of radio distortion characteristics of electrical lighting and similar equipment
    • TS EN 61547 General lighting devices - EMC immunity rules
    • TS EN 61000 Electromagnetic compatibility (EMC)
  • Regarding energy,
    • TS EN 62722 Fixture performance
    • TS EN IEC 62442 Energy performance of the lamp controller
  • Regarding RoHS,
    • TS EN IEC 63000 Technical documentation for the evaluation of electronic and electrical products according to the limitation of hazardous substances

CE Certification of luminaries is only one of the services provided by Eurotech Assessment and Certification Services Pvt. Ltd. among many others. Many other certification services like CE Certification for medical devices, electrical/electronics, construction, pressure equipment, RoHS etc. are also available. We also provide testing services for your electrical/electronic products through our sister concern.

For more information, contact trg@eurotechworld.net or fill out the form below to get your QUOTE for CE Certification today.

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CE Certification for Bulbs

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CE Mark on the bulbs that are provided to consumers includes various requirements like RoHS, electromagnetic compatibility (EMC), Eco-Design and safety. Though the EMC, RoHS and security requirements have been addressed intensively for years, Eco-Design requirement has been added to these recently.

These 4 requirements are imperative for all bulbs regardless of where they are used. The products covered under Eco-Design must bear the CE mark and manufacturers need to declare their conformity within the framework of the Energy Related Products Directive 2009/125/ EC.

Energy efficiency, safety & other legal requirements have been introduced for lighting products that the consumers need to fulfill within the borders of the European Union. The standards and directives that should be taken into consideration for CE marking the bulbs and the preparation of the declaration of conformity are:

  • Low Voltage Directive (LVD) - 2014/35/EU
  • TS EN 61347 Lamp control system
  • Electromagnetic Compatibility Directive (EMC) - 2014/30/EU
  • Electromagnetic interference (EMI)
  • TS EN 55015 Limit values ​​and measurement methods of radio distortion characteristics of electrical lighting and similar equipment
  • TS EN 61000 Electromagnetic compatibility (EMC)
  • TS EN 62493 Inspection of illumination equipment for people exposed to electromagnetic fields
  • Electromagnetic sensitivity
  • TS EN 61547 General lighting devices - EMC immunity rules
  • TS EN 61000 Electromagnetic compatibility (EMC)
  • 2009/125/EC Energy Related Products Directive (Eco-Design)
  • Hibernate power
  • 2011/65/EU Restriction of Hazardous Substances (RoHS) Directive
  • TS EN IEC 63000 Technical documentation for the evaluation of electrical and electronic products according to the limitation of hazardous substances.

For producing a good product, the production and design must be in line with the aforementioned safety standards. These standards include equipment such as lamp holders called luminaires in the lighting industry and lamps. Products designed and manufactured corresponding to these standards are normally subject to legal regulations of the Low Voltage Directive (LVD), the Electrical Equipment Safety Directive and the General Product Safety Directive.

The European Union Directives have many more requirements in addition to safety that have to be taken into account during the design, production & final disposal of the lighting product. Some of these additional requirements are:

  • Electromagnetic Compatibility Directive (EMC): This directive is applicable on electrical and electronic products and comprehends the immunity to electromagnetic interference and electromagnetic emissions.
  • Energy Related Products Directive (ERP): This applies mostly on lighting products and covers minimum energy efficiency & performance considerations.
  • Resistance of Hazardous Substances Directive (RoHS): Applies to all electrical products and prevents use of certain substances.
    Waste Electrical and Electronic Equipment Directive (WEEE): Applies to all electrical products and covers the disposal and recycling of waste.
  • Registration and Evaluation of Chemicals Directive (REACH): It is applicable on all products and covers the notification and restriction of certain chemicals.
  • Energy labeling (of lamps): It is the application of energy labeling between LV and is applied to residential lamps, though it can be extended to all lamps.

CE mark is only applied on some types of lighting products. The CE marking of the product is done after completion of the required documentation and declaration of conformity. This proves that the products are manufactured in accordance with the requirements stated in the directives mentioned above.

CE Certification of bulbs service is only one of the services provided by Eurotech Assessment and Certification Services Pvt. Ltd. among many others. Many other certification services like CE Certification for medical devices, electrical/electronics, construction, pressure equipment, RoHS etc. are also available. We also provide testing services for your electrical/electronic products through our sister concern.

For more information, contact trg@eurotechworld.net or fill out the form below to get your QUOTE for CE Certification today

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CE Certification for Surgical Mask

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CE marking is a certification application that started in European Union (EU) countries. CE marked products can be used and sold without any restrictions within the European Union. Products bearing CE mark have proven to meet all health, safety and environmental requirements. However, now it has become a generally accepted practice all over the world.

All personal protective equipment like dust masks, work shoes, work gloves and other PPE must be certified in accordance with CE criteria. The users of the products bearing this mark, are assured that the product is safe and provides strong protection. The CE mark on the device and equipment used in the medical field contributes a separate safety and reliability. Surgical masks are also included in this. The fundamental use of a surgical mask is to prevent the biological particles that will spread through the mask from the wearer of the respiratory tract into the working environment and to other people or patient.

In order to put CE mark on surgical masks, the main standard that needs to be complied with is the TS EN 149 standard (Respiratory protective devices - Half masks with filters for protection against particles - Properties, experiments and marking standard). This standard states the minimum conditions for half masks with filters, respiratory equipment used for protection against particles that cannot be removed from the environment.

Surgical masks that conform to EN 149 should fit tightly on the face and have a sealing between the mask and the face. If the masks are designed as such, breathable air does not escape through the mask wall and passes through filter. This is the reason for why it is important for surgical masks to pass the conformity test.

Surgical masks of type N95 (FFP3) particle filter fall under the third category within the scope of PPE and are masks that meet the standard requirements. Additionally, they must meet the resistance tests against splashes of blood or other infectious liquids. Surgical masks are mainly used in operating rooms.

Only those surgical masks that pass these tests under the responsibility of the manufacturer can bear the CE mark and get CE Certification.

Eurotech Assessment and Certification Services Pvt. Ltd. provides CE Mark Certification for all classes of Medical Devices. Within the scope of our certification services, we also provide CE Certification for surgical masks. Our Certification Team of experts help you in meeting all the essential requirements of Medical Devices Directive of the European Union. We not only provide Certification but also provide testing services for your medical device through our sister concern.

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