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CE Marking & Machine Safety

There are demands on you as a manufacturer/importer

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Machine Safety

Regardless of whether it is about manufacturing or assembling a machine, or parts for a machine line, demands are made on machine safety, risk analysis, risk assessment and CE marking.

Do you need help with CE marking & machine safety?
You don't want gravel in the machinery, do you? Should you manufacture a machine, assemble several machines or parts into a machine line or import a machine from a country outside the EU, then there are requirements for you as a manufacturer or importer. If you change an already CE-marked machine, the machine's safety has been affected and at least a risk analysis and risk assessment is required.
It is stated in the machinery directive 2006/42/EC and the implementation in Swedish law which is AFS 2008:3 but simply put it is everything that moves and then some. However, the machine must not be covered by any other directive, e.g. a vehicle directive.
This is tricky as a machine can be covered by a number of global, European and national requirements depending on what it is. For example. in addition to requirements for machine safety, there may be requirements for food hygiene, ATEX, pressure vessels, EMC and specific customer requirements.
Regarding machine safety, the machine directive 2006/42/EC applies, which is a so-called "New approach" directive that only sets out basic principles. The directive then refers to technical standards that specify requirements for different types of machines or subsystems of machines.
Examples of standards we often use are:
  • EN ISO 12100:2010
    Machine safety - General design principles - Risk assessment and risk reduction
  • SS-EN ISO 13849-1:2016
    Safety of machinery - Safety-related parts of control systems - Part 1: General design principles
  • SS-EN 13155:2021
    Lifting cranes - Safety - Loose lifting gear
The Machinery Directive is currently under development and will likely become a regulation.
All information that forms the basis of a CE marking must be collected in what is called a technical file. This technical file must be available to market control bodies for 10 years.
In most cases, you can carry out all the checks yourself, but if you are not used to it, it can be difficult to understand and time-consuming, so DEKRA is happy to help you as an independent party with specialists in machine safety who guide you so that you meet the requirements.
When manufacturing a new machine, we can:
  • Review the basic health and safety requirements
  • Lead and support the risk assessment of the machine
  • Training within the Machinery Directive, use of work equipment and risk assessments
  • Review/create the instruction manual for the machine
  • Check and review that the technical documentation meets the requirements and that you have a complete technical file.
Should you buy a new machine, we can assist with:
  • Impartial advice on what requirements you can and should place on the manufacturer
  • Document check that the machine you are going to buy meets the safety requirements of the machinery directive
  • Inspection of the machine at the manufacturer during manufacture or before delivery
Measurements and assessments, we help you with:
  • Status assessment of existing machines in your machine park
  • Lifetime assessment of machines
  • Measurement/control of noise, vibrations and emissions
  • Accident investigations
  • Test lift for lifting equipment and lifting machines
You decide this, but DEKRA often carries out an inspection which results in a report which shows what is wrong and which source we have for the assessment. We then often assist as a sounding board to explain the deviations. Some customers also want a follow-up check that any deviations have been corrected and that all product safety requirements have been met.
DEKRA in Sweden is accredited to carry out EC type checks according to 2006/42/EC Annex IX of Vehicle lifts and Devices for lifting people or people and goods which entail a risk of falling from a height exceeding 3 m. We can also help with type checks of other particularly dangerous machines listed in Annex IV 2006/42/EC via our global organization. The EC type inspection results in an EC type inspection certificate which is valid as an EC type approval throughout the EU.
Notified Bodies (Notified Bodies) are independent organizations with competence to assist and monitor the work of manufacturers in verifying that the products placed on the market meet the rules that apply within the EU. This is done through testing, control and certification in accordance with EU legislation.
Source: Swedac, Board for Accreditation and Technical Control

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Contact
DEKRA Consulting AB

Lagergatan 5

415 11 Göteborg

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