CE Risk Analysis
CE Risk Analysis
(OP)
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?
Thanks.
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?
Thanks.





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:
http://www.era.co.uk/news/pr0406.asp
RE: CE Risk Analysis
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
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
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
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
"..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."