Medical Device Standards - Difference between IEC and EN Standards

Marc

Fully vaccinated are you?
Leader
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

looking for answers
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

Fully vaccinated are you?
Leader
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?
 

Marc

Fully vaccinated are you?
Leader
Is there a cross reference anywhere which lists standards which are both EN and IEC?
 

Marcelo

Inactive Registered Visitor
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)
 

Ronen E

Problem Solver
Moderator
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

Technically, the MDD is not "law". It must be transposed into national law in each of the member states, before it's requirements become enforceable. It's different to CFR in that sense, and it also involves a much greater scope than part 820 (which only deals with QS).

BTW, the transition from IEC (or ISO) to EN is not necessarily an adoption per-se, but it can involve modifications.

Cheers,
Ronen.
 
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Ronen E

Problem Solver
Moderator
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?

Just to add another bit - the MDD doesn't directly relate to IEC standards at all. The only standards that have an official status with regards to the MDD requirements are EN ones. However, a NB may well accept an IEC (or ISO etc.), non-EN, standard implementation as satisfying certain MDD requirements and/or as matching with the state of the art in the subject field.
 
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