The development of a Technical construction file and CE Conformity Declaration of work equipment, to obtain the CE marking, and fulfilling the machinery Directive 2006/42/EC.
Note: The new Regulation (UE) 2023/1230 will be applied from january 2027, and it will repeal Directive 2006/42/EC.
The steps to follow to obtain the Technical construction file of machines or work equipment are the following:
2.1.- INITIAL EVALUATION: New manufactured machine, or substantially modified machine
In these cases, it consists in an evaluation/ audit of the machine/ work equipment, in order to learn about its characteristics, design, drawings, etc., in other words, the state of the machine will be examined, as well as all the available documentation.
2.2.- DEVELOPMENT OF THE TECHNICAL CONSTRUCTION FILE
DISTEC and the client will do a Technical construction file, including the following different sections, among others:
- Risk assessment of the work equipment, using Failure Mode and Effect Analysis (FMEA) method or similar.
- Analysis of the health and safety requirements, related to the design and manufacturing of machine/work equipment, according to the machinery directive 2006/42/EC.
- Development of an instruction manual of the work equipment
- Design and manufacturing drawings. Component diagrams of machines, sub-assemblies and circuits
- Results of calculations done during the design, and checkings done
- Risk assessment
2.3.- CONFORMITY DECLARATION
A CE conformity declaration must be done for every machine / safety component.
This declaration includes the manufacturer data, description of the product, references according to the directives applied, identification of the signing person (manufacturer or legal representative), and manufacturing year.
Every work equipment will have a legible and permanent plate, that will have at least the indications of the machinery directive.
All work equipment manufactured after 01/01/1995, will have to comply with the machinery directive.
Every machine or work equipment that was manufactured before 01/01/1995, but it was substantially modified, will have to comply also with the machinery directive.