Welcome to our new ongoing blog series, Ask Lewis Bass!

This series will feature actual submitted questions from companies in the industries we provide engineering safety consulting services to.

Topics covered will include those associated with our work in 3rd party field labeling, SEMI S2/S8/EMC/F47 testing and design, CE Marking evaluations, and general engineering safety consulting questions.

Question:

Hi Lewis Bass, I’d like to know more about CE marking certification requirements where there are family classifications for identical tools.

Can you help me get clarity on the below queries?

1. System A is CE certified by a third party. System B, C, D are exact copies of System A, do we need to CE certify Systems B, C, D individually?
   • How can we use the test report from system A on System B, C, D for CE declaration?
2. If two systems are identical but have two different part numbers do we need to CE certify them separately?
3. If a component is changed to a different manufacturer with the same technical spec do we need to re-certify?
4. What type of change constitutes a re-certification for CE?

Asked by Richard in Sunnyvale, CA

 

Lewis Bass:

These are great questions about the finer points of CE Marking, Richard. We are glad you asked us about this situation, as this will be a great learning experience for other companies facing this exact same scenario.

Your answers are listed  below in the order you asked them:

1) System A is CE certified by third party. System B, C, D are exact copies of System A, do we need to CE certify Systems B, C, D individually?

Answer: No, you can certify with the old original report.

1a) How can we use the test report from system A on System B, C, D for CE declaration?

Answer: Just change the serial # or have a range of serial numbers from the first report that apply to that line of machines. The evaluating engineer would also need to draft a new letter (and so would your company) per machine with its own technical file per machine.

2) If two systems are identical but have two different part numbers do we need to CE certify them separately?

Answer: Yes. They should probably have different DoC ‘s (Declaration of Conformity) for each and can share the same technical file. This would also require a new declaration letter per machine.

3) If a component is changed to a different manufacturer with the same technical spec do we need to re-certify?

Answer: Per CE Standard 18.7: Retesting – Where a portion of the machine or its associated equipment is changed or modified, the need for re-verification and testing of the electrical equipment shall be considered.
The onus is on the manufacturer to prove it conforms and to update the technical file as appropriate. The keyword here in the above excerpt is “shall” which means you absolutely must in legal terms re-verify the system in its entirety.

4) What type of change constitutes a re-certification for CE?

Answer: 1) When new CE documents (standards) are released. 2) A change of a major component or operation. 3) When the manufacturer is executing “Due Diligence” in regard to safety.

Thanks very much for these great questions on CE Marking, Richard. We hope these answers help you and your team get the ball moving on your company’s CE certification process for your machines.

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