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> CE machine conformity
CE machine conformity
1. Preliminary Assessment
Determine the applicable directives and regulations.
Identify the relevant harmonized standards.
Assess the intended use and user requirements.
2. Documentation Preparation
Compile the technical documentation (technical file).
Include design and manufacturing specifications.
Document risk assessment and management processes.
3. Risk Assessment
Identify potential hazards associated with the machine.
Evaluate risks and implement mitigation measures.
Document the risk assessment findings.
4. Compliance Testing
Conduct necessary tests to verify compliance with standards.
Ensure testing is performed by accredited laboratories if required.
Document test results and any corrective actions taken.
5. Declaration of Conformity
Prepare the EU Declaration of Conformity.
Ensure all required information is included (e.g., product details, manufacturer information).
Sign and date the declaration.
6. Marking and Labeling
Affix the CE marking to the machine appropriately.
Ensure compliance with labeling requirements (e.g., warnings, instructions).
Verify that documentation accompanies the machine.
7. Post-Market Surveillance
Establish procedures for monitoring the machine's performance in the market.
Collect feedback from users and address any issues.
Maintain records of incidents or non-conformities.
8. Continuous Compliance
Review and update documentation regularly.
Stay informed about changes in regulations and standards.
Implement a process for re-evaluation if modifications are made to the machine.
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