CE Marking

CE Marking

Process equipment used for biopharmaceuticals, pharmaceuticals, and fine chemicals frequently needs to be CE marked. We are very familiar with the CE marking requirements in these industries.

Process Industry CE Marking Requirements

Equipment in the process industry are covered by a number of CE marking directives including:
  • ATEX 100a
  • EMC
  • Low Voltage
  • Machinery
  • Pressure.
We are very familiar with the requirements of these directives within the process industry.

ATEX 100a

Non-electrical equipment used in potentially explosive atmospheres is subject to the ATEX 100a directive and needs to comply with relevant EN standards. Category 2 and 3 non-electrical equpment do not require certification by a notified body, so are only subject to self-certification. We are familiar with the requirements of self-certification.

One important requirement is to carry out an ignition hazard assessment in compliance with EN ISO 80079 Part 36. We can help our clients with this assessment.

Machinery Directive - Partly Completed Machinery

It is often the case that process equpment falls into the category of partly completed machinery and is provided with a Declaration of Incorporation. This declaration will state that the equipment cannot be used until it has been incorporated.

We are familiar with incorporation of process equipment and can help our clients overcome the issues associated with partly completed machinery.

We can also carry out risk assessments in line with EN ISO 12100.

Request an information leaflet

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