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> compliance to machine directive 2006/42/ec
compliance to machine directive 2006/42/ec
1. General Requirements
Verify that the machine is designed and constructed to be safe for its intended use.
Ensure that all essential health and safety requirements (EHSRs) are identified and addressed.
Confirm that the machine conforms to relevant harmonized standards.
2. Technical Documentation
Prepare a technical file that includes design and manufacturing documentation.
Include risk assessment and risk reduction measures taken.
Document instructions for use, maintenance, and safety information.
3. Risk Assessment
Conduct a thorough risk assessment to identify potential hazards.
Evaluate risks associated with machine operation, maintenance, and installation.
Implement measures to eliminate or reduce identified risks.
4. Conformity Assessment
Determine the applicable conformity assessment procedure based on the machine category.
If necessary, involve a notified body for assessment and certification.
Keep records of conformity assessment results and certificates issued.
5. Declaration of Conformity
Prepare and sign the EU Declaration of Conformity.
Ensure that the declaration includes all relevant information, such as machine identification and applicable directives.
Keep the declaration readily available for inspection.
6. Marking and Labeling
Affix the CE mark to the machine in accordance with directive requirements.
Ensure that the mark is visible, legible, and indelible.
Provide necessary warnings and safety labels on the machine.
7. Post-Market Surveillance
Establish a system for monitoring the machine’s performance in the market.
Document any incidents, recalls, or corrective actions taken.
Review and update risk assessments and safety measures as necessary.
8. Maintenance of Compliance
Regularly review compliance with the directive and harmonized standards.
Update documentation and procedures as necessary to reflect changes in the machine or regulations.
Provide training and information to staff regarding compliance and safety practices.
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