En 550/554 - The European Commission Standards Harmonization


Aaron Lupo

Well I figured I would start here and see what happens. Does anyone out there know anything about EN 550/554, they are Validation and Routine Control of Sterilization by Moist Heat and Ethylene Oxide Sterilization. I have asked our Registrar for a checklist of what they audit to and they do not have one. Does anyone out here have one or know where I could find one. I am in the process of developing one and would like others to look at for ideas.:smokin:

Aaron Lupo

I have finished these if anyone in the Medical Device Industry is interested.


Hey ISO Guy,

I realize that this is coming a little late for your project, but...maybe it'll help someone else.

I used to be in the medical devices field and used BSI for both ISO 9000 and the MDD CE Mark. The guidance I got from them was to pick the appropriate standards for what I was making, using the hierarchy of EN standard first, International standard second, National standard third, and Industry standrd last. From that I put together an appropriate list for my business.

When looking for EN standards, here's the web site I used most frequently to get the harmonized EN standards for each of the medical device directives:

When there were no harmonized standards on a particular subject, I frequently got very good direction from the FDA's DSMA helpline.

Europa is a very good site for EU issues.
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