Technical files

Industrial sector

Directives usually address broad product families, as is easily understood from their titles:

– Directive 2006/42/EC Machineries
– Directive 2006/95/EC Low Voltage Material
– Directive 2004/108/EC Electromagnetic compatibility (EMC).

They also address a number of other products, such as Gas appliances, Pressure Equipment and Devices and, on existing Directives there is a continuous updating and tuning.

For each product the company must identify applicable Directives and prepare the Technical File, to be kept available for surveillance Authorities; in this documentation together with basic information such as:

– identification of manufacturer (or of the subject placing the product on the market)
– product description and intended use
we assemble documents such as:
– Specifications / drawings / schemes, according to what needed
– Software documentation if any
– Results of type testing / product qualification studies / certification
– Manufacturing procedures and instructions
– Use, installation and maintenance instructions.

settore industrialeThe criterion to be used in this work comes out from the risk analysis, generally carried out according to applicable EN technical standards.

European Authorities assigns a great value to the operator responsibility; the subject placing the product on te market can usually proceed preparing the Technical File under his responsibility; in most critical cases the intervention of a technical inspection body (Notified Body) is required.