Low Voltage Directive 2014/35/EU
This Directive shall apply to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current, It applies to a wide range of electrical equipment for both consumer and professional usage, such as;
• household appliances
• power supply units
• laser equipment
• certain components, e.g. fuses.
For products with multiple voltage ratings, input or output, the products are considered within the scope of the LVD as soon as the highest of the ratings falls within the given voltage rating. Accordingly, electrical equipment exceeding 1000 V AC or 1500 V DC falls outside the scope of the Directive, as such equipment is not designed for use within the voltage ratings set by Article 1 of the Directive.
Battery operated equipment outside the voltage rating is obviously outside the scope of the LVD. Nevertheless, any accompanying battery-charger as well as equipment with integrated power supply unit within the voltage ranges of the LVD are in the scope of the LVD. This applies also, in the case of battery operated equipment with supply voltage rating below 50 V AC and 75 V DC, for their accompanying power supply unit (e.g. laptops).
In general, the scope of the LVD includes both electrical equipment intended for incorporation into other equipment and equipment intended to be used directly without being incorporated.
However, some types of electrical devices, designed and manufactured for being used as basic components to be incorporated into other electrical equipment, are such that their safety to a very large extent depends on how they are integrated into the final product and the overall characteristics of the final product. These basic components include electronic and certain other components.
Taking into account the objectives of the LVD, such basic components, the safety of which can only, to a very large extent, be assessed taking into account how they are incorporated and for which a risk assessment cannot be undertaken, then they are not covered as such by the LVD. In particular, they must not be CE marked unless covered by other Union legislation that requires CE marking.
However, other electrical components that are intended to be incorporated into other equipment and for which a risk assessment can be undertaken, such as transformers and electrical motors, are covered as such by the LVD and must be CE marked.
The general product safety directive (2001/95/EC) covers consumer goods with a voltage below 50 V for alternating current, or below 75 V for direct current. It aims to ensure that only safe consumer products are sold in the EU.
Equipment Outside The Scope Of The Directive
• 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
• Specialised electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.
• Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.
‘making available on the market’ means any supply of electrical equipment for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
‘placing on the market’ means the first making available of electrical equipment on the Union market;
‘technical specification’ means a document that prescribes technical requirements to be fulfilled by an electrical equipment;
‘conformity assessment’ means the process demonstrating whether the safety objectives set out in Annex I of the directive relating to electrical equipment have been fulfilled;
‘CE marking’ means a marking by which the manufacturer indicates that the electrical equipment is in conformity with the applicable requirements set out in Union harmonisation legislation.
Mandatory Safety Requirements
The LVD lays down the conditions to which electrical equipment should meet before being CE Marked and placed on the market;
All electrical equipment should be design and constructed taking into account good engineering practice in relation to safety matters. This means that the electrical equipment must be designed and manufactured according to the state of the art. (i.e. latest published standard)
Designed and constructed to conform with the principal elements of the safety objectives which are shown at Annex I to the LVD. These are the mandatory safety provisions, which electrical equipment must comply with in order to be allowed onto the Union market.
Electrical equipment must not pose a danger to health and safety of persons, domestic animals or damage to property when properly installed, maintained and used as intended by the manufacturer.
The Machinery Directive 2006/42/EC has additional requirements for safety and reliability of control systems detailed in Annex I clause 1.2.1 which states; Control systems must be designed and constructed to prevent hazardous situations from arising. Above all, they must be designed and constructed in such a way that: They can withstand the intended operating stresses and external influences, while a fault in the hardware or the software of the control system does not lead to hazardous situations. Errors in the control system logic do not lead to hazardous situations, and reasonably foreseeable human error during operation does not lead to hazardous situations.
The Low Voltage Directive places the responsibility to perform conformity assessment on the manufacturer: the manufacturer performs the conformity assessment and documents the assessment in his own right.
If you are a manufacturer, you have to follow these 7 steps to ensure compliance to the CE marking requirements:
1. Identify the applicable directive(s) and harmonised standards
2. Verify product specific requirements
3. Identify whether an independent conformity assessment (by a notified body) is necessary "There is no conformity assessment procedure in the LVD Directive which requires the intervention of a notified body".
4. Test the product and check its conformity
5. Draw up and keep available the required technical documentation
6. Affix the CE marking and draw up the EU Declaration of Conformity.
7. Ensure that procedures are in place for series production to remain in conformity with the applied Directive(s). "Changes in product design or characteristics and changes in the harmonised standards the international or national standards, or in other technical specifications by reference to which conformity of electrical equipment is declared shall be adequately taken into account".
Standards have been defined as "an agreed, repeatable way of doing something". Normally they are published documents containing technical information to guide or define practice in a consistent way, and are used by designers and manufacturers of products to establish conformity.
Standards are valuable tools that can help your business to:
• ensure the quality and safety of products and/or services
• achieve compatibility between products and/or components
• access markets and sell to customers in other countries
• satisfy your customers’ expectations and requirements
• reduce costs, eliminate waste and improve efficiency
• comply with relevant legislation including EU regulations
• gain knowledge about new technologies and innovations
Knowing which standards to use, and how to apply them in the correct way, is vital for the
success of your business. It is also important to understand how standards contribute to the regulatory process.
Most EN Standards require the manufacturer to conduct a level of testing to ensure the product meets the requirements of the standard and how to document this for the technical file
The extent of verification will be given in the dedicated product standard for a particular
piece of electrical equipment. Where there is no dedicated product standard for the electrical equipment, the verification's shall always include the items a), b), c) and h) and may include one or more of the items d) to g):
a) verification that the electrical equipment complies with its technical documentation;
b) verification of continuity of the protective bonding circuit;
c) in case of fault protection by automatic disconnection of supply, conditions for protection
by automatic disconnection shall be verified;
d) insulation resistance test;
e) voltage test;
f) protection against residual voltage;
g) verification that the relevant requirements of the applied standard are met;
h) functional tests.
Identify the applicable directive(s) and harmonised standards
When developing any product you first need to identify the mandatory regulations in the region you wish to place your product on the market, this can be achieved by reviewing the government websites, I know this is not easy and time consuming, but this is where we can help. Note; If a regulation quotes a standard then that standard becomes mandatory too, but in the majority of cases standards are voluntary.
In European Union the directive states that a product is safe if it meets all statutory safety requirements under European or national law. If there are no regulations or EU standards, the product's compliance is determined according to other reference documents such as international standards, commission recommendations, codes of practice. This is most useful when supplying a new state of the art product on the market.
In accordance with LVD electrical equipment which is in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, is to be presumed to be in conformity with the safety objectives.
Verify product specific requirements
Unfortunately, there is only one way a manufacturer can hand on heart say that is product meets a particular standard(s) and that's to conduct or have conducted a clause by clause assessment against the applicable harmonised standards used to demonstrate compliance listed in the official journal, always remembering that additional directives may need to be considered like EMC and RoHS. Note; if you use an international standard, industrial standard which are not in the official journal you will be required to show how you have addressed the safety requirements in Annex I of the directive
The manufacturer shall ensure compliance of the manufactured electrical equipment with the technical documentation, (think! Quality Plan)
The documentation shall make it possible to assess the electrical equipment’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture, and operation of the electrical equipment.
The technical documentation shall, where applicable, contain at least the following elements:
• a design risk assessment to ISO 12100:2010 the risk assessment demonstrating the procedure followed, including:
• a list of the safety objectives which apply to the equipment,
• the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the electrical equipment,
• a general description of the electrical equipment,
• conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
• descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the electrical equipment;
• a list of standards and other technical specifications applied, indicating the safety objectives covered by these standards if not using a harmonised standard,
• any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,
• a copy of the instructions for the electrical equipment,
• a copy of the EC declaration of conformity;
• for series manufacture, the internal measures that will be implemented to ensure that the electrical equipment remains in conformity with the provisions of this Directive.
• The original manufacturers instructions necessary for identification, transport, installation, use, maintenance, decommissioning and disposal of the electrical equipment shall be documented
Affix the CE mark
The manufacturer shall affix the CE Mark to each individual electrical equipment that satisfies the applicable requirements of the Low Voltage Directive.
The following information shall be legibly and durably marked in a way that is plainly visible
after the equipment is installed: Typical markings are as follows
• name or trade mark of manufacturer;
• type designation or model, where applicable;
• serial number where applicable;
• year of manufacturer (mm-year), where applicable;
• main document number (see IEC 62023) where applicable;
• rated voltage, number of phases and frequency (if AC), and full-load current for each incoming supply.
• the CE Mark
It is recommended that this information is provided adjacent to the main incoming supply(ies).
EU declaration of conformity
The EU declaration of conformity is the written statement and the a single declaration drawn up by the manufacturer to demonstrate the fulfilment of the EU requirements relating to a product bearing the CE marking he has manufactured. The declaration shall be in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonisation legislation to which the declaration relates.
This declaration must cover one or more products manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer, or his European Authorised Representative if the manufacturer is based outside the EU.
The EU declaration of conformity must contain the following particulars:
In accordance with of European Parliament and Council Decision No 768/2008/EC Annex III
1. Company Header, Logo or Trademark
2. Title; EU Declaration of Conformity
3. No … (unique identification of the product):
4. Name and address of the manufacturer or his authorised representative:
5. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
6. Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):
7. The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: …
8. References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:
9. Where applicable, the notified body ... (name, number) … performed … (description of intervention) … and issued the certificate: …
10. Additional information:
The technical documentation for the electrical equipment is available from:
• Name of manufacturer or authorised representative Storing T/F in Europe>
• manufacturer or authorised representative>
Signed for and on behalf of:
(place and date of issue):
(name, function) (signature):
HOW WE CAN HELP:
Our customers contact us because they need help and advice on how to apply the UKCA or CE Mark to their products.
The CE Marking Authority has a positive attitude and approaches regulatory compliance by looking at the opportunities rather than seeing them as an inconvenience and meddling with your practices. We specialize in staying ahead of the game by using our technical knowledge (skills) conducting the necessary assessments to help our clients demonstrate their technical files meet the requirements of the regulations
Our expert team is here to help you meet the UKCA and CE Marking the requirements
• Free initial consultation to assess your requirements and plan the CE marking of your product.
• Identify the statutory instruments, the essential safety requirements, and harmonized standards, which apply to the product.
• Perform design risk assessments and clause by clause assessments against the designated standards
• Conduct a product compliance report to the applicable requirements outlining areas of non-compliance and advice on how to close out any gaps found.
• Assist in the compilation of the technical construction file, which contains the information required by the EU safety regulations.
• Provide a draft EU Declaration of Conformity and help you complete it.
• Offer follow up advice on changes in requirements for the life cycle of the product
• Act as your Authorised Representative in the UK or EU via or European office if required.
The many benefits of compliance range from brand and reputation, revenue enhancement, asset protection, higher profitability, and lower costs, improved workforce performance, the provision of better data for better-made business decisions, and allows for a total harmonization of your systems