CE Marking

CE marking indicates that a product has been assessed according to the EU norms & deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

In order to comply the product to achieve CE marking, identification of appropriate EU Directive(s), Harmonized Standard(s) & fulfilment of ESHR (Essential Safety & Health) requirements are one of the important step.

TuBroTICs is an Authorized Partner of EU Notified Body- CerTrust, Budapest, Hungary can provide the below services which are accredited by European Union:

    • Machinery Directive: 2006/42/EC

    • EMC Directive: 2014/30/EU

    • Radio Equipment Directive (RED) : 2014/53/EU

    • Pyrotechnic Articles : 2013/29/EU

    • Appliances Burning Gaseous Fuels: Regulation (EU) 2016/426

    • Low Voltage Directive 2014/35/EU

    • RoHS Directive 2011/65/EU

How TuBroTICs can support you?

  • Identification of relevant Directive & Harmonized standards

  • Compliance testing according to European / IEC standards

  • End to end solution & guidance for CE Marking compliance

  • Product development stage to compliance stage guidance

  • Guidance on preparation of Technical Construction File

  • Issuance of "EC Type Examination Certificate" & "Certificate of Conformity" from EU Notified Body.

Machinery Directive 2006/42/EC

Machines and installations require a particularly thorough testing and compliance process to ensure they’re market-approved.

Machinery Directive (2006/42/EC) is the EU legislation documents applicable to the Machinery products and certain part of the machinery. It is very important documents used to comply the essential health and safety requirements for the Machinery products sold in European Union. This new directive as it is a “New Approach” directive, promotes and ensure harmonization through a combination of mandatory health and safety requirements and voluntary harmonized standards. This directive applies to machinery as well as safety components, lifting accessories, partly completed machinery chains/ropes/webbing, and removable mechanical transmission devices.

The main objective of this directive is to ensure the safety of the machinery, minimize and eliminated the hazardous situations. The Directive prompt:

  • free movement of machinery within European Union - the single market

  • guarantees a high level of protection for EU workers and common citizens

Adoption of Machinery Directive

The Machinery Directive (2006/42/EC) published on 9th June 2006 and became applicable on 29th December 2009. The directive was amended with regard to machinery for pesticide application by Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 and by Regulation (EU) No 167/2013 on 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles, among others.

Product covered under Machinery Directive (2006/42/EC)

Machinery consists of an assembly of components have moving parts, joined together for a specific application powered by energy other than human or animal effort. The Directive applicable to the following type of the products:

  • Packaging machinery

  • Paper cutting and binding machine

  • CNC machines

  • Extruders

  • woodworking machines

  • Earth-moving machinery

  • Agricultural machinery

  • Textile machinery

  • industrial laundry machinery

  • Conveying, spraying machines etc.

Product which are not cover under Machinery Directive (2006/42/EC) are:

  • Lifting appliances whose speed is not greater than 0,15 m/s,

  • construction site hoists,

  • cableways, including funicular railways,

  • lifts specially designed and constructed for military or police purposes,

  • lifting appliances from which work can be carried out,

  • mine winding gear,

  • lifting appliances intended for lifting performers during artistic performances,

  • lifting appliances fitted in means of transport,

  • lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery,

  • rack and pinion trains,

  • escalators and mechanical walkways.

Assessing the conformity of machinery

  1. Machinery except Annex IV listed machinery, the manufacturer or his authorized representative can complies the Annex VIII for internal checks for the assessment of conformity.

  2. Machinery referred in Annex IV and manufactured in accordance with the harmonized standards referred to in Article 7(2) can use following options:

  • Annex VIII for internal checks for the assessment of conformity.

  • Annex IX for EC type-examination procedure(by Notified Body), plus the internal checks on the manufacture as per Annex VIII

  • Annex X for full quality assurance procedure.

  1. If the Machinery referred in Annex IV is not manufacturer as per harmonized standards or does not have harmonised standard, conformity can be done by following means:

  • the EC type-examination procedure provided for in Annex IX, plus the internal checks

  • the full quality assurance procedure as per Annex X

Assessing the conformity for partial completed machinery

For partial completed machinery we can adopt following procedure for the conformity assessment:

  • the technical documentation described in Annex VII, part B

  • assembly instructions described in Annex VI

A declaration of incorporation Conformity Procedure:

For Conformity we need to adopt four steps:

  • Identify the applicable conformity module and requirements – Assess the requirements of notified body

  • Identify the applicable Standards

  • Testing and assessment as per standards and directive including ANNEX I Essential health and safety requirements relating to the design and construction of machinery

  • Prepare the Technical Construction File and Declaration of conformity

For a Machinery, there are more than one Directive can be applicable. For example we see Injection moulding machine then with Machinery Directive other main directive applicable are Low Voltage Directive (2014/35/EU) and Electromagnetic Compatibility Directive (2014/30/EU).

Directive Revision

The technology is changing in a past pace and one evaluation conducted on the effectiveness on the Machinery Directive and it shows that directive is relatively flexible to technological development and generally relevant, effective and efficient. However it is understand that some of the provision require better clarity and coherence with other Directives. Some of other Directive requirements need to simplify. In the view of these input a revision process is going on and in some time we may see a new machinery regulation.

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Low Voltage Directive 2014/35/EU

Low Voltage Directive (2014/35/EU)

If you want to export electrical and similar products in European Market then your product must complies the Low Voltage Directive. The Directive applies within certain voltage limit. The latest Low Voltage Directive (LVD) (2014/35/EU) adopted and applicable from April 20, 2016 and it ensures that electrical equipment within certain voltage limits provides a high level of protection of health and safety of persons and the end users and also benefits fully from the Single Market.

Low Voltage Directive (2014/35/EU) Scope:

The Low Voltage Directive apply to electrical equipment designed for use with a voltage rating of between:

  • 50 and 1000 V for alternating current (AC)

  • 75 and 1500 V for direct current (DC)

LVD is for the safety objective

One major point about LVD is that this directive is only limited to the expression of safety objectives. And in order to facilities conformity assessment with those objectives, it is necessary to provide for a presumption of conformity for electrical equipment which is in conformity with harmonized standards and if harmonized standards do not exist then conformity assessment can be achieved by complying the respective applicable international standards laid down by the International Electrotechnical Commission or by applying national standards.

It applies to a wide range of electrical equipment for both consumer and professional usage, such as:

  • household appliances

  • power supply units

  • laser equipment

  • Luminaire

  • certain components, e.g. relays, fuses

  • Appliance couplers

  • Switches

  • Voltage detectors

  • adapters

The Directive applicable to standalone electrical equipment or electrical equipment’s incorporation into other equipment, within defined certain voltage limit. LVD is also applicable to the products with other Directive. For a Machinery, Low voltage directive is applicable with other Machinery Directive and Electromagnetic Directive.

It must be noted that certain electrical products are not covered under LVD directive such as

  • Electrical equipment for use in an explosive atmosphere

  • Electrical equipment for radiology and medical purposes

  • Electrical parts for goods and passenger lifts

  • Electricity meters

  • Plugs and socket-outlets for domestic use

  • Electric fence controllers

  • Radio-electrical interference

  • Specialized electrical equipment, for use on ships, aircraft or railways

  • Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes

It must be noted that other consumer goods with a voltage below 50 V for alternating current, or below 75 V for direct current, cover under General Product Safety Directive. The purpose of this directive is only to ensure that safe consumer products are sold in the EU market.

Principle elements of safety objectives:

There are some principle elements within LVD which are safety objective for the electrical equipment designed within certain voltage limits. These principle directly affects the design and development of the products. By taking care and understanding of these rules one can easily complies the requirements of this directive. We are discussing these condition one by one:

General Conditions:

  1. recognition and observance shall be marked on the electrical equipment to ensure that electrical equipment will be used safely and in applications for which it was made

  2. electrical equipment should be properly assembled and connected, together with its component parts and made in such a way as to ensure that it can be safely used

  3. electrical equipment should designed and manufactured to comply the requirements set out in next two section is assured.

Protection against hazards arising from the electrical equipment

  1. persons and domestic animals are adequately protected by direct or indirect contact against the danger of physical injury or other harm which might be caused;

  2. adequate protection against high temperatures, arcs or radiation which would cause a danger in normal use.

  3. adequately protection against non-electrical dangers caused by the electrical equipment which are revealed by experience;

  4. the insulation is suitable for foreseeable conditions.

Protection against hazards which may be caused by external influences

Technical measures in order to ensure that the electrical equipment:

  1. meets the expected mechanical requirements

  2. is resistant to non-mechanical influences in expected environmental conditions

  3. does not endanger persons, domestic animals and property in the conditions of overload.

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EMC Directive 2014/30/EU

In today life, we are all surrounding with the Electronics Products. Form Household products to industrial application, electronics is everywhere. We are all familiar with the benefits of all these products but there are some hidden harmful effect which comes in terms of electromagnetic radiations. All electronics products emit electromagnetic radiations, some has higher and some has less radiations level. These radiations not only effect human health but also one device influence other device or got influenced. Devices which are interconnected or near each other produces interference which may affect normal functioning of that product. Products like TV sets, GSM handsets, radios and nearby washing machine, industrial machinery or electrical power lines produces interference. We can’t reduce these radiation to zero but can reduce them significantly so that it mat effect less.

Electromagnetic Compatibility (EMC) Directive (2014/30/EU) is the EU legislation documents ensure that the electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance/radiations. EMC Directive was published on 29 March 2014 and repealed Directive 2004/108/EC as from 20 April 2016.

The main objectives of the directive is to regulate the compatibility of equipment regarding EMC. Electromagnetic Compatibility (EMC) Directive (2014/30/EU) limits the equipment electromagnetic emissions and ensure that the equipment, used as intended, such equipment does not disturb radio and telecommunication, as well as other equipment. Same is applicable for the immunity side. The immunity of such equipment to interference and seeks to ensure that this equipment is not disturbed by radio emissions. Electronics products are also need to be assess as per Low Voltage Directive (2014/30/EC)

Since we have seen electronics component everywhere so we have wide range of harmonized standards to complies the EMC requirements. EMC is basically three types:

  • Emission: generation of electromagnetic energy

  • Susceptibility: equipment inherent nature to malfunction or break down in the presence of unwanted emissions

  • Immunity: ability of equipment to function correctly in the presence of RFI

Major EMC Tests are:

  • Conducted Emission - EN 55016-2-1

  • Radiated emission - EN 55016-2-3

  • Electro-static discharge immunity - EN 61000-4-2

  • Electrical fast transient/burst immunity - EN 61000-4-4

  • Combination wave surge immunity - EN 61000-4-5

  • Conducted Radio Frequency Immunity - EN 61000-4-6

  • Power Frequency Magnetic Fields (PFMF) - EN 61000-4-8

  • Voltage Dips & Interruption - EN 61000-4-11

Conformity of Equipment as per EMC Directive

Equipment which is in conformity with harmonised standards shall be presumed to be in conformity with the essential requirements set out in Annex I.

Conformity assessment procedures as per EMC Directive

Compliance of Equipment set out in Annex I can be achieve as follows:

  1. Internal production control as per Annex II of Directive

  2. EU type examination followed by Conformity to type based on internal production control as per in Annex III of Directive

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