Catalogs > Safety Products Catalog > Principles, Standards and Implementation > Regulations
Regulations
| EU Directives and Legislation |  |
The Machinery Directive | |
Essential Health & Safety Requirements | |
Conformity Assessment | |
Technical File | |
Conformity Assessment for Annex IV Machines | |
| Notified Bodies | |
EC Type Examination | |
EC Declaration of Conformity Procedure | |
EC Declaration of Incorporation | |
The Use of Work Equipment Directive | |
Regulations 1 to 10 | |
| Regulations 11 to 24 | |
US Regulations | |
Occupational Safety and Health Administration | |
Canada Regulations | |
The person responsible for a declaration of conformity must ensure the following documentation will be available (Figure 4) on the premises for inspection purposes.
A technical file including:
| 1. | Overall drawings of the equipment including control circuit drawings. |
| 2. | Detailed drawings, calculation notes, etc. required for checking the conformity of the machinery with the EHSRs. |
| 3. | A list of: |
- The EHSRs relevant to the equipment.
- Applicable Harmonized European Standards.
- Other applicable standards.
- Technical design specifications.
| 4. | A description of methods adopted to eliminate hazards presented by the machinery. |
| 5. | If desired, any technical report or certificate obtained from an approved body (test house) or laboratory. |
| 6. | If conformity is declared with a Harmonized European Standard, any technical report giving test results for it. |
| 7. | A copy of the instructions for the machinery. |
For series manufacture, details of internal measures (quality systems, for example) to ensure all machinery produced remains in conformity:
- The manufacturer must carry out necessary research or tests on components, fittings or the completed machinery to determine whether by its design and construction it is capable of being erected and put into service safely.
- The technical file need not exist as a permanent single file, but it must be possible to assemble it to make it available in a reasonable time. It must be available for ten years following production of the last unit. Failure to make it available in response to a substantiated request by an enforcement authority may constitute grounds for doubting the conformity.
The technical file does not need to include detailed plans or any other specific information regarding sub-assemblies used for the manufacture of the machinery, unless they are essential to verify conformity with the EHSRs.
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| Figure 4: Technical File Must Be Available |