EN 285:2006 and EN 285:2015 - Can we test according to EN 285 ourself?

Hello everybody.

Does anybody knows can we testing according to EN 285 standard ourselfs? (With calibrated measuring instruments, created tests etc.) Medical device for testing is steam sterilizer.

Or that testing, and issuing test report and certificate must be conducted from external (certified) side, some laboratory for testing or something like that.

Thanks in advance.

EN285 for large-scale steam sterilizers does not impose specific restrictions on who performs the measurements and tests within the scope of this standard. As long as you can demonstrate that your testing is valid, you should be all fine. In practice, it is common, that a good part of the testing required by EN285 is performed by the equipment manufacturer.


Thanks a lot Gerhard!
I will give my best to provide enough validity to our Notify Body.
I looking for Certified Laboratories, but no effect.
All the best, Stefan

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