CE Mark

What is a CE Mark?

CE is an abbreviation for ‘Conformité Européenne’, French for ‘European Conformity’. The CE Mark for machinery is the manufacturer’s guarantee that the machine meets the safety requirements for the European Union.

In the US, requirements for worker and construction safety have been pushed by insurance affiliations (Underwriters Lab, Factory Mutual, National Fire Protection Association, etc). In Europe, similar requirements have been pushed by the labor unions. The codes are similar but the enforcement is completely different.

The European safety requirements are expressed in the numerous “Directives” that have the force of law. Compliance can be evidenced by either a direct assessment of the EH&S Annex (Environmental Health and Safety), or by using appropriate normalized standards (European norms).

The “Declaration of Conformity” gets the equipment into Europe. The “CE Mark” permits the equipment to travel across the borders, somewhat like a visa stamp on a passport. The evidence of conformity is a well written report (including a hazard analysis) plus a technical construction file.

Typical scope of work:

The CE Mark evaluation will review the machine against the following directives and standards:

  • Machinery Directive 2006/42/EC annex 1, essential health and safety requirements
  • Low Voltage Directive 2006/95/EC annex 1, principal elements of safety objects, plus detailed assessment using EN 60204 and 61010 as guides
  • Standard for Safety of Machinery – Electrical Equipment, EN 60204-1, 5th edition, 2005, equivalent to Electrical Standard for Industrial Machinery, NFPA 79
  • Standard for Safety of Laboratory Equipment , EN 61010-1, 3rd edition, 2010
  • Electromagnetic Compatibility 2004/108/EC
  • RoHS Directive 2011/65/EC assessment for components free from lead, and other hazardous chemicals and metals.

The CE Mark safety compliance report provides a record of “due diligence”, and along with conformity to the EMC Directive, providing the basis for the self Declaration of Conformity.

Electromagnetic compatibility (EMC) would usually include an in situ test for:

  • Radiated interference (signals coming out of the machine that typically interfere with other electrical equipment, including telecommunication networks)
  • Susceptibility (signals going into the machine that could cause safety hazards or system anomalies, typically from handheld radios and cell phones)
  • Electrostatic discharge (caused by environmental effects and electrical switching devices in the facility plus charge buildup on a person’s body)

Deliverables:

  • Punchlist of non-conforming items, if necessary.
  • Safety report containing a line-by-line discussion of conformity to the appropriate CE Mark Directives and Standards, including EN 60204-1, suitable for presentation to a customer.
  • Draft of the Declaration of Conformity.
  • EMC test report accompanied by a new Technical Construction File (TCF)

Resources

See the CE Mark Section of the Resource Library


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