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Harmonised Standards

When you design your product, you start off with a conceptual idea, then keep adding to it until you have a product which works as you intended it to. The problem is although it may function perfectly and look fabulous, unless it meets the stringent requirements of the applicable Product Legislation the closest the customer will get to it will be the pretty pictures on the website.

Unfortunately most companies do not consider CE Marking until they are in the end phase of their product launch, which may mean a lot of expensive changes to a production ready product. The preferred route, or at least the one we would advise, is to design in the necessary measures to meet the applicable Directives / Regulations from day one of the design process.

To do this you need to know which particular standard, out of the +100,000’s on offer, both apply to your product and will just as importantly count towards your conformity process when it comes to CE marking. Although there are technically 100’s of thousands of standards on offer, to cover just about every product under the sun, not all are viewed equally by the Legislation the product needs to meet.

There is a rather refined list of standards listed for each of the Directives & Regulations, which offer sufficient technical detail to meet the requirements of the applicable Legislation if the standard is wholly applied to the product.

These standards are called ‘Harmonised Standards’.

They are listed on something called the ‘Official Journal’, which is simply a webpage which details the standards number and name, along with the date it becomes applicable to newly designed products.

Popular CE Marking Directives & Regulations

* Although EMC and Radio Equipment standards are listed, on their own pages, they are purely test specification standards and as such will be of little use to the designer unless you have a fully equipped EMC lab to hand.

Each of the Directives integrates harmonised standards slightly differently, but either way they are the best bet for one stop conformity.


Low Voltage Directive

Under the Low Voltage Directive it is advisable to wholly apply a harmonised standard, as the best way to demonstrate conformity:

Low Voltage Directive 2014/35/EU (Article 12):

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 shall be presumed to be in conformity with the safety objectives referred to in Article 3 and set out in Annex I covered by those standards or parts thereof.

If you cannot apply a harmonised standard due to functional, rather than monetary, aesthetic or preferential reasons then you must still ensure your product meets the ‘Safety Objectives’ listed in Annex I of the Directive, which are very generic, which will no doubt be used to the prosecutions advantage should a court case ever occur. As such lean on the side of safer is better when assessing against the Safety Objectives.

 Machinery Directive

Whereas under the Machinery Directive things become a little more complicated. Although the Directive simply asks for a harmonised standard to be used:

Machinery Directive 2006/42/EC – Presumption of conformity and harmonised standards (Article 7)

2. Machinery manufactured in conformity with a harmonised standard, the references to which have been published in the Official Journal of the European Union, shall be presumed to comply with the essential health and safety requirements covered by such a harmonised standard.

It is complicated by the fact that there are different levels of standards from the basic safety Type A, through to slightly less generic Type B, onto machine specific Type C standards.

Only the Type C standards cover all of the Essential Health and Safety requirements of the Machinery Directive.

As such unless a machine specific Type C standard is wholly applied then you must also assess the product against the Essential Health and Safety requirements of the Machinery Directive.

* They are conveniently listed by their type on the Official Journal webpage.

Construction Products Regulation

Uniquely under the Construction Products Regulation (CPR), unless your product falls under a harmonised standard you cannot CE mark your product in the first place. For more information see our page on the CPR.

For more help and advice on harmonised standards, then please call us on 01564 792349