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FAQ's about Product Safety

 
 
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How does a manufacturer choose between the Low Voltage and Machinery Directives?
Clearly if the equipment does not have any moving parts, then by definition it is not a machine and the LVD will apply alone. The question arises when a piece of electrical apparatus is also a machine, or when a machine is electrically powered or controlled. The Machinery directive article 1.5 requires that where the risks to health and safety are "mainly" of electrical origin", then the machinery is covered "exclusively" by the LVD. The problem is that this can sometimes be very difficult to judge. If there is any doubt as to whether the risks are mainly electrical, the Machinery Directive should be applied but the standards used to demonstrate compliance should include an LVD standard, in order to fully and diligently cover the electrical aspects of the machine. For more information on this question, please see the document, "The Overlap of Machinery and Low Voltage."


How does this relate to UL certification?
Answer: UL certification is not directly acceptable for the purposes of complying with the LVD. The directive relies primarily on the use of published harmonized standards with UL, e.g. in the case of UL 1950 being equivalent to EN60950; the UL standards in general are not the same in every respect to the European Norms. However, it is not mandatory to comply with the ENs and UL standards and test can be offered as proof of compliance with the Safety objectives of the LVD as long as thorough explanation and justifications are given. This is an instance where it may be prudent to obtain a Safety Report from a notified body to support the claim of compliance.


How do the standards relate to the Essential Health & Safety Requirements?
Answer: The EHSRs in the Machinery directive and the Safety Objectives in the LVD give broad requirements to ensure the safety of persons, domestic animals and property. They are not technical specifications, in that they do not define any specific design or build requirements, merely the desired results. The directives have supporting them standards (the ENs) which can be used to demonstrate compliance with their requirements and there is a presumption of compliance where published harmonized standards are applied. It is important to understand that in the Machinery directive and LVD, as in all "New Approach" directives, it is the EHSRs and Safety objectives which must be complied with by law.


When will I be required to prepare and maintain a Technical File for LVD?
The Low Voltage Directive became mandatory on January 1, 1997 for
manufacturers of most electronic products shipping to the European Union.


What can a Notified Body report provide?
The notified body will examine the product and the supporting documentation
such as test results and technical data and give an opinion on the compliance of the
product with the Safety Objectives of the LVD. Although this report is not mandatory and the manufacturer is at liberty to self-certify without such a report, there may be
circumstances, for example where ENs or other standards have not been applied, when it would be prudent for the manufacturer to seek such a professional second opinion, in order to have a higher degree of confidence in the safety of the product and to demonstrate due diligence.


Is domestic testing allowed to prove EU compliance?
Yes, as long as it can be shown if required that the necessary tests and
evaluations have been properly identified and carried out.


Can I add other safety marks to the product if I have the CE Marking?
Other marks may be applied to the product to indicate safety standards have
been complied as long as these marks do not obscure or become confused with the CE
marking. Although the amending directive 93/68/EEC will remove the need to have safety marks from certification bodies as a way of showing legal compliance, it does not preclude the continued use of these marks. Often it is a customer or contractual requirement that such marks are on the product and these cases where it is felt that a commercial disadvantage may accrue from dropping the marks, they will be retained. They do not signify the same things as the CE marking.


What happens if enforcement authorities have a question about a product?
The Trading Standards Officers will seek out the "responsible person" who under the LVD must reside in the EU and must retain the supporting documentation. If they suspect the product is not safe, they may seek a report from a notified body, before commencing legal proceedings to stop supply of the product.


How do I know what standards to apply to my product?
Seek advice from a consultant, test laboratory, or notified body.


What does the "responsible person" have to do for a Technical File?
Here there are some differences between the Machinery directive and the LVD.
For machinery, the responsible person can be the manufacturer outside the EU, the
authorized representative inside the EU or the user (importer) of the machine. The RP
must be able to assemble the file on demand by the authorities. It does not need to be
complete.
 
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