The concepts ‘directives’ and ‘standards’ appear in practice to cause quite some confusion. A directive is a ‘law’ that obliges the member states to incorporate it into their national legislation; thus, a directive must be complied with. A ‘standard’ does not have legal status, but a voluntary character. Certain (harmonised) European standards give the manufacturer the so-called ‘presumption of conformity’ with the stipulations of the directive. For more on this, see our information page ‘Standards’.
Given below are brief summary descriptions of frequently-encountered directives; only the texts of the directives themselves are legally valid.
In the Working Conditions Decree, a paragraph on ‘explosive atmospheres’ has been applicable since July 2003; this is aimed at preventing gas and dust explosions. The Working Conditions Decree makes it mandatory to take a structured approach to explosion hazards.
For the application of this directive, the following is to be understood by:
- “pressure equipment” or “pressure devices”: pressure vessels, industrial piping, safety accessories and pressure accessories. In so far as is applicable, pressure equipment also includes elements that are attached to pressurised components, such as flanges, nozzles, couplings, lifting lugs, etc.
- “assemblies”: various pieces of pressure equipment which a manufacturer has assembled to constitute an integrated and functional whole.
In the directive, pressure equipment is classified according to increasing risk, in categories from I to IV. Determinative for this classification are the type, the material in the pressure equipment, the maximum allowable pressure (design pressure) and the volume or the diameter of the pressure equipment.
A medical device is any instrument, apparatus or appliance that is used to diagnose, monitor or treat a disease, injury or handicap in humans. The term “medical device” applies to a broad range of products, devices and equipment, from simple tongue depressors and bedpans to laser surgical devices. Medical devices can also include certain electronic radiation emitting devices with medical applications, including ultrasound devices and x-ray machines.
Toys have to be safe for children to play with. Ensuring that toys marketed in the EU do not put children at risk is a priority. EU legislation aims to ensure that toys meet safety requirements that are amongst the strictest in the world, especially in relation to the use of chemicals in toys.
There are two possible conformity assessments allowing toys to be sold in the EU. The manufacturer has to demonstrate the compliance of a toy by: self-verification by using the European harmonised Standards third party verification through a notified body. All toys sold in the EU must carry a CE marking. This is the manufacturer’s declaration that the toy satisfies the essential safety requirements.
Construction products include a wide range of products, such as bricks, cement, timber, concrete, steel, as well as complex structure, such as facades. So, construction product means any product or kit which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works.
If your construction product fall into the scope of European harmonised Standards, next step will be to test the product and check its conformity, as well as Factory Production Control that includes quality control of procedures. After all required testing and controls the manufacturer should compile Technical Documentation and draw up Declaration of Performance (DoP). Based on those documents the CE marking can be affixed, and only after that the product can be sold within European Economic Area.
The General Product Safety Directive (GPSD) (2001/95/EC) sets out safety requirements for all consumer products being placed on the European market, but unlike other European Directives, the GPSD is not a CE marking Directive. The act of placing the product on the market is the only act required to illustrate that product has been assessed and found to comply with the general safety requirements.
The General Product Safety Directive sets out to ensure that all products placed on the market are safe. To comply the GPSD, a manufacturer shall undertake and document an assessment that covers the risks and risk categories associated with the product. The recommended method of undertaking such an assessment is through the application of voluntary European Harmonised Standards.
The Directive is purely self-assessment with no requirement to involve a third party. Manufacturers are not required to complete a Declaration or Certificate and they do not need to affix any conformity markings (other than the information identified to be supplied for the safe use of the product). Whilst you do not need to involve a third party, you can do so at your choice.
To ensure the safety of your customers and your employees it is necessary to understand the risks associated with the machines and devices with which they are dealing.
The legislation in the field of explosion danger is in Europe split into two well-matched sub-areas: the ATEX 114 directive for manufacturers of explosion-proof equipment and the ATEX 153 for users of equipment in potentially explosive environments.