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For equipment with moving parts compliance with the Machinery Directive 2006/42/EC is necessary before placing a CE marking on the equipment.
The Machinery Directive is available for download at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006L0042-20091215
Definition of machinery from Machinery Directive:
(a) ‘machinery’ means:
— an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,
— an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,
— an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,
— assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
— an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;
Even simple assemblies of moving parts fall under this definition. There are some exceptions for simpler equipment, e.g. computers with only cooling fans when these simpler products are covered by other directives addressing the lower level hazards.
Evaluation and Testing to Harmonized Standards
The Machinery Directive identifies a list of essential health and safety requirements that need to be considered and addressed as applicable. The best way to guarantee compliance is to assess the equipment to applicable harmonized standards published in the Official Journal of the EU. We identify the applicable standards from that list in our quoting process and review the machinery to the applicable requirements of those standards during our engineering evaluation process.
Safety Related Circuits
Assemblies of certified safety components integrated to achieve safe operation and access to machinery need to comply with the requirements of EN13849-1 and EN 13849-2 – Safety Related Parts of Control Systems. These standards are difficult to understand and use. We have the necessary background and experience to help ensure hazards are suitably categorized and designed to meet these difficult requirements. We prepare Sistema format reports for safety related circuit compliance as a part of our service.
Technical File Preparation
The Machinery Directive requires that a technical file be put together to document compliance with the provisions of the directive. Our technical files are prepared in electronic format and consist of the following folders (and more where necessary):
- Declaration of conformity
- Engineering Evaluation and changes for compliance
- Risk Assessment
- Safety Related Circuit report
- Electrical Circuit diagrams
- Hydraulic and Pneumatic circuit diagrams
- Component specification sheets
- Test Data
- Installation/Operation/Maintenance Manual
- Machine Drawings
- Guard Drawings
- MSDS Sheets
- Folders are also provided for all other applicable directives for the manufacturer to populate
These folders are populated by us with the information provided during the review when technical file preparation is requested.