EUROPEAN LEGISLATION AND TECHNICAL TRANSLATION: MANUAL OF INSTRUCTIONS, OPERATING INSTRUCTIONS OR USER MANUAL?

One of the main difficulties of the technical translation is technical language and the necessity of having the technical knowledge required to understand and translate the contentsBut, beyond this, there are more things that a technical translator must know to be able to correctly confront this type of documents, that are regulated by different European regulations.

The European regulatory jungle

Firstly, we have the Directive 2001/95/EC on general safety of products, which applies to all products with the exception of food, pharmaceutical products and medical devices, which have their own regulations. This directive lays down that every product that may have risks for the user should include "relevant warnings, drafted in clear and easily understandable way, on the risks it may present, in the official languages of the Member State" "in which is marketed." A safe product must include labeling, as well as Assembly instructions and, if applicable, maintenance, possible warnings and instructions of use and disposal, as well as any other indication or information regarding the product. It is the manufacturer, Distributor, and importer (economic agents) who assume the responsibilities arising from damage or casualties because of insufficient or erroneous instructions. As we can see, this directive introduces the terms of labelingAssembly instructions, maintenance, alerts, instructions for use, removal instructions instructions having its official translation in languages European.
Apart from this general directive, there are a number of specific rules for certain sectors or products. Currently, about 85% of these specific rules are harmonies in the EU. This means that in all EU countries apply the same rules, which have been transposed in the respective countries, and whose concepts have an official translation that the translator should know.
Some examples of harmonized standards are the directive 2009/48/EC on the safety of toys, the 2014/30/EC electromagnetic compatibility directive, 98/37/EC machinery directive, and many more. These standards also include specific requirements about the documentation of products, packaging and labeling, as well as the instructions accompanying the product.

The CE marking

For many products, there are specific European rules requiring the CE marking to be marketed in the European economic area, a symbol which certifies that the product meets the requirements of safety, health and protection of the environment required by the EUHowever, for other products, such as furniture, textiles, laminate floors, books, coffee capsules and others, there is a specific European standard requiring the CE marking.
According to the Royal Decree 1644 / 2008 it transposes in Spain with the European rules, prior to marketing or putting into service of a product, the manufacturer or his authorized representative shall:
  • Check what standards are applicable to your product.
  • Perform a risk analysis of the product.
  • Write the instruction manual.
  • Carry out the appropriate conformity assessment procedures .
  • Draw up the EC declaration of conformity and make sure that this Declaration is attached to the machine.
  • Place the CE marking.
The technical file, also called technical documentation in the regulations, must kept for 10 years and be submitted at the request of the competent body with its corresponding language translation required or, in some agencies, in English. Translate this type of records or, which is more common, the instruction manuals that are derived from them, requires knowing the regulations on which they are based.

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