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CE Risk Analysis

CE Risk Analysis

CE Risk Analysis

Hi everyone.

I know that one of the steps in CE Certification is to elaborate a Technical File, and I´ve heard that this file has to contain a Risk Analysis, but I couldn´t find any information about it. Does anyone know what is this Risk Analysis? What kind of information should it contain?


RE: CE Risk Analysis

I think you are better searching under "Risk Assessment" rather than simply analysis.
Determine the CE Directive you are needed to meet and then decide on the necessary steps. Directives such as the Machinery and Low Voltage Directives will have obvious issues pertaining to risk.
In a previous life I used a company ERA to assist covering certain steps for CE certification for products. This section off their website might give you a few pointers:

RE: CE Risk Analysis

Hi sed2developer ,

First of all, thanks for the reply.
I read the info you pointed, and I could understand that the need of risk assessment depend on the directives that the equipment has to comply. My equipment is a portable (battery powered) data collector, and it has to comply with the three directives listed below:
1. Directive 89/336/EEC (EMC Directive)
2. Directive 2002/96/EC (WEEE);
3. Directive 2002/95/EC (RoHS);
Do you know if any of these Directives require a Risk Assessment or Risk Analysis?

Best Regards

RE: CE Risk Analysis

Risk assessment is part of these Directives. As you will be putting a Techncal Construction File together you have the responsibility to outline the potential risks,; be it High, medium or Low and outline what they are. EMC I would say for a portable battery powered device is minimal for it's ability to impact other equipment but EMC is about immunity as well as Emissions and so you will need to understand the level of immunity required of your product and the environments it will be placed. You don't want it to stop working if intererence from other equipment (could be quite legitimate) causes yours to stop. It could be, for example, that your equipment is medical equipment and therefore the risk is that it could either interfere with other equipment in the same local etc.
For EMC, unless you have facilities yourself, a qualified body would need to carry out the testing. They will also outline any risks.
Just a few examples.
RoHs and WEEE certainly require Risk assessment carried out.

I'm no expert but there are plenty of them out there.

RE: CE Risk Analysis

Regarding the level of immunity required of our product and the environments it will be placed, we are trying to comply with class A. My major doubt was about the risk assessment. I´ve never seen a risk assessment in my life, so I don´t know how to start doing it. I believe I will have to make a spreadsheet with the potential risks of RoHS and WEEE implementation (like the confiability of electronic component´s suppliers regarding the presence of hardazous substances in the component or the possibility of any of these substances to introduced in my equipment at any process of fabrication , like assemblying, for example), and maybe with the potential risks that my equipment may offer to the electromagnetic envirorment (if it passes in the EMC tests, there will be no risk).
Am I wright? Would you have any example or guide that explains how to organize the informations in this risk assessment for RoHS and WEEE Directives?

Thanks for your atention.

RE: CE Risk Analysis

I would advise understanding Failure Mode and Effect Analysis.

We produce goods to the Pressure Equipment Directive and have used FMEAs as a reliable and objective method of performing a risk analysis.

Risk analysis is an analysis of the possible failures a product may have, the impact of those failures and how the probability of that risk is lowered, controlled and eliminated.

RE: CE Risk Analysis

It's worth remembering that the Technical File

"..need not permanently exist but it must must be possible to assemble it and make it available within a period of time commensurate with its importance."

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