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I am building a CNC product and all the electronics parts we are using are either FCC or CE certified. Do I then have to obtain a separate certification for the product as a whole ?

Also any idea what are the labelling requirements for such a product ?

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CE marking is an administrative marking that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.

The CE mark is mandatory for 'machinery and equipment', irrespective of individual components being CE or FCC certified.

The CNC product would definitely fall under this category.

Applicable directives would be 'Machinery Directive', 'Low Voltage Directive' and 'EMC directive'.

In order to meet CE Marking requirements the CNC product would need to comply with all relevant CE standards.

All electrical equipment and controls on the machine would be required to comply with EN 60204-1 'Safety of Machinery: Electrical Equipment of Machines'. The safeguards, tooling / fixturing, software and documentation would also need to be covered. This is to ensure that the safety of people using the machine would be guaranteed, the control responses of the machine would be consistent, and the machine would be easy to maintain throughout its lifetime.

A risk assessment would also be required to be performed as per the requirements of ISO 12100 (2010) 'Safety of machinery - General principles for design - risk assessment and risk reduction'.

For a start, it would be advisable for key personnel to attend a training programme on CE marking. Secondly, availing the services of a certifying agency and involvement of key personnel would go a long way in achieving 'self-certification' in the long term.

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    \$\begingroup\$ In case one or several functions are regarded as safety-critical, you also need to make some manner of ISO 13849-1 document regarding functional safety. This needs to link together with the risk assessment which serves to identify the safety functions. While the ISO 13849-1 is meant to prove that the safety functions are actually safe, although that particular standard is all about templates, guesswork and meaningless MTTF calculations on components. \$\endgroup\$
    – Lundin
    Commented Nov 17, 2020 at 14:13
  • \$\begingroup\$ Thank you both these are fantastic responses and a lot of detail. Really appreciate you taking the time out to respond. \$\endgroup\$
    – Tapan
    Commented Nov 17, 2020 at 15:04
  • \$\begingroup\$ @Lundin, Yes, safety-critical functions, specific to the machine, are to be identified with ISO 13849-1 as basis for carrying out the risk assessment. Many thanks. \$\endgroup\$
    – vu2nan
    Commented Nov 17, 2020 at 15:30
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    \$\begingroup\$ Rather, the ISO 12100 etc will require a "FMEA" which will identify the hazards and the means to avoid them. From there on you can list how probable a hazard is and how hard it is for the operator and others to avoid it. These parameters in turn mean that you can pick a required "performance level" of the safety function in ISO 13849-1. \$\endgroup\$
    – Lundin
    Commented Nov 18, 2020 at 7:30
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    \$\begingroup\$ Oh and btw, the RoHS directive is also required for CE marking in this case. \$\endgroup\$
    – Lundin
    Commented Nov 18, 2020 at 7:31

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