Citing EN standards

[pseudoazurin]

Hi just want to check with the general opinions about the citing format (the actual standard no. is irrelvant). An old product, say was tested to comply with EN 60601-1 (ed.2) ages ago, and now in my IFU, should I say that it is comply with EN60601-1 (ed.2) or IEC 60601-1 (ed.2), disregard the whether (ed.2) is still useful or recognized or not, the thing is the standard (e.g. 60601-1) is no longer EN now (however it was), and the testing and the test report or documentation-wise were all EN 60601-1.

Have a nice weekend.

 

[yodon]

Compliance to the harmonized standards (EN) is what gives you presumption of conformity to the regulatory requirements. If you use a different version, you'll likely need to explain the differences between the harmonized version and what you tested to and why the version you tested to meets the requirements.

 

[pseudoazurin]

Thanks, but that did not answer the question about citing the standard in IFU. I don't think any company would retest the product. It was tested to comply with the then EN 1234:5678 standard, then time flies, the current version is EN 1234:5689, so in my IFU I inclined to continoue to stay that it is comply with EN1234:5678, rather than IEC:1234:5678, as my test report and TD all said so (disregard MDD to MDR dissusion here).

 

[yodon]

Ack... sorry, completely missed the IFU part. :-/ Honestly, I don't think it matters if you include the revision in the IFU. I can see cases where the revision changes (and you possibly re-test) but wouldn't need to update the IFU. None of the IFUs I've seen include revision info for a standards reference. In fact, the ones I've seen don't even mention the EN part, just the base standard (e.g., IEC 60601-1). Don't expect that many users would have much interest in versions and such.

 

[pseudoazurin]

Thanks, I may be the few that would like to be as correct as possible.
I can see that stating EN seems to help my claim of compliance to "MDD", but on the other, what is the point of stating and outdating"ex-EN" EN.

 

[Mark Meer]

Here's what I'd suggest: create a table in your technical documentation explaining what was tested, the current harmonised version, and notes about compliance. A 4-column table might have the following entry:

• Standard: IEC 12345
• Tested: IEC 12345:2003
• Harmonised: EN 12345:2004
• Compliance Notes: Main text of standard unchanged between IEC & EN versions.

Such a table is also useful when standards get updated, you do a gap analysis, and find that your previous test results are still applicable. Such an entry might look like:

• Standard: IEC 12345
• Tested: EN 12345:2004
• Harmonised: EN 12345:2004/AM1:2009
• Compliance Notes: Amendment does not affect tested results. Criteria for all documented tests is unchanged in harmonised version.

In the IFU cite what was tested, and in your CE declaration cite the EN versions that you comply with (table above in your TD will explain any differences).

 

[levatorsuperioris]

Remember, with state of the art requirements you are expected to fulfill all the latest standards EN versions. You would do this by comparing different revisions and gap analysis and remediation. Hence by default you comply to the newest standard and that can be in your IFU.

If you do not comply to the newest standard you should be remediating and working towards compliance, the IFU would be changed then after your are finished.

Finally if you do not comply and you do not intend to remediate to state of the art, then you should pull the product from markets utilizing your CE mark and in which case IFU changes are not necessary.