ER Checklist - Method(s) of conformity

tebusse

Involved In Discussions
#1
All,

I'm putting together my first essential requirement checklists for two Class I medical devices in preparation for CE Marking. One of these medical devices is electrical and we've had a 3rd party vendor conduct CB scheme testing.

For applicable ERs, I believe I can list the standard documented on the test certificates to which our device was found to be in conformity with - correct?

However, I'm noticing that the test certificates and the test reports do not have the same standards listed. Am I also able to list the standards from the test reports for applicable ERs?

Thank you, Tonia
 
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shimonv

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#2
For applicable ERs, I believe I can list the standard documented on the test certificates to which our device was found to be in conformity with - correct?
Yes.

However, I'm noticing that the test certificates and the test reports do not have the same standards listed. Am I also able to list the standards from the test reports for applicable ERs?
Usually one test report is issued per one tested standard. I recommend to list just one standard (e.g. IEC 60601-1) and in parallel send and inquiry to the test lab to sort out this seemingly discrepency.
 
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