Medical Device Standards - Difference between IEC and EN Standards

[Marc]

What is the difference between IEC and EN Standards? Medical devices aren't my specialty. I'm not asking for a long explanation - Just a brief explanation so I can better follow along with the discussions and make better "tags" for threads. For all intents and purposes I have a lot of EN threads tagged with IEC tags because it appears to me there are EN and IEC versions of the same standard.

Also - How do the MDD standards fit into all of this?

[rob73]

IEC and EN (CEN/CENELEC) are standards similar in context to ISO and BS, a IEC standard with an EN in the title means it has been adopted as a Euro Norm (or European Standard).
MDD (medical devices directive) is the EU's legislation on the safety and manufacture of medical devices and comes above standards i.e. you may not need ISO 13485 or ISO 9001 to manufacture, but you must be compliant with the MDD in order to CE mark the device before placing on the market (in the EU).
Rob

[Marc]

So MDD's are essentially EU laws (legislation), and they trump IEC & EN standards?

Are all EN standards "sub" IEC standards, or are there "stand alone" EN standards with no connection to an IEC standard?

[rob73]

The MDD are similar to the FDA requirements 21 CFR 820 and form part of European law. i.e. It is illegal to sell medical devices in Europe without the CE mark (showing MDD compliance).
Yes there are stand alone EN standards, see http://www.cen.eu/cen/Products/EN/Pages/default.aspx
Rob

[Marc]

Is there a cross reference anywhere which lists standards which are both EN and IEC?

[Marcelo Antunes]

IEC standards are international.

EN standards are european. EN means European Norm.

EN IEC is the european implementation of the IEC standard.

There's EN standards which are not IEC or ISO implementation (pure EN, for example EN 13060 on small steam sterilizers).

Standards are voluntary.

Directives are legislations, mandatory.

You can use standards to fulfill requirements of directives.

Yes there is.

Look at this link. It will also show you which ones are published as an EN or other country designation Standard.

I searched the IEC site on "Medical" and this is what popped up...

Stijloor.

There's no cross-reference. Stij, in the link you posted, EN is for ENglish, not European Norm. (FR - French, SP Spanish)

[Stijloor]

Very sorry!! I deleted my very incorrect post.

Stijloor.

[Marc]

Looks like we're both learning, Jan!