Harmonization date of IEC 60601-1 , 3rd Edition

[temujin]

Dear Forum,

Does anyone know when the 3rd edition of 60601-1 will be harmonized?
(I mean are we talking years here...)?

Will all the collateral and particular standards have to be updated before the 3rd edition can be harmonized?

regards
temu

[Steve McQuality]

Originally Posted by temujin

Dear Forum,

Does anyone know when the 3rd edition of 60601-1 will be harmonized?
(I mean are we talking years here...)?

Will all the collateral and particular standards have to be updated before the 3rd edition can be harmonized?

regards
temu

Hi Temujin:

I just sat in on a Webinar sponsored by Intertek a couple weeks ago. The speaker from the Webinar indicated that the DOP (Date of Publication) of Ed. 3 was 12-Sep-2006 and the DOW (Date of Withdrawl) of Ed. 2 will be 3 years hence, on 12-Sep-2009. He also indicated that a lot of the colateral standards (Part 1 & 2 standards) will be getting released in 2008.

I hope this helps. Keep your eyes open for the particular colateral standards that apply directly to your type of equipment.

-Steve

[mmantunes]

Just some clarificatios...although the standard was published in the date mentioned by Steve and the DOW of the standard itself is correct, it still isn´t published as an harmonized standar and therefore there´s no DOW for the standard used as a regulatory compliance mechanism (if you want to understand the differences between a standard being published and a standard being used in regulatory schemes, take a look at this thread: When should the medical device industry show compliance to EN ISO 14971(2007)).

Regarding particular standards, IEC (NOT CENELEC - remember, harmonizaed standard have to be EN) has a target date of publishing new versions of particular standard aligned to IEC 6060101:2005 until the end of 2008.

Colaterall standards are already harmonized (IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-1-8)

Theoretically you do not need to wait for the particular be published to use the new edition (the risk management loop guarantees that the hazards adressed by particular have to be taken into accout), but legally speaking i think it´ll be sometime, at least when the EN collaterals and some particulars be published before the standards are harmonized.

[Steve McQuality]

mmantunes:

Thanks for the additional clarification to my original post. After you mentioned the "harmonized standard" reference, I seem to recall that discussion in the Webinar as well. There was some discussion about the EU typically being way ahead of the US and Canada, but I had forgotten the particulars.

This is why I like this forum so much. Some one like me as "part of the story" and there seems generally to be someone who always has the additional details for the "better answer" to the question posed!

-Steve

[mmantunes]

Hello Steve, i totally agree with you on the the off-topic..this is, in my opinion, one of the strenghts of the knowledge building in this community...

Anyway, you´re right when you say that the EU are almost always ahead on regulatory requirements... actually, the regulatory requirements of medical devices in the worls are gearing towards the EU model, as can be seen by the work of the Global Harmonization Task Force... even the EUA, which has a fundamental difference in approach, are slowly turning to the EU model (but it might time some time).

One interesting point regarding particulars is that not all of them will be aligned with the third edition..because some might be cancelled! IEC posted a internal rule on the development of particulars that says taht if a particular doesn´t reach CDV (comittee draft fot vote) stage at the beginning of 2008, then the standard will be revoked. This is because some particulars standard writing groups weren´t active in developing the new edition and IEC felt this was because of lack of interest.

So, complementing my complementation to the question from Temu, i don´t think they´ll wait for every particular to be published, because they don´t even know how many particulars will remain.

Cheers.

[wrodnigg]

EN 60601-1 has been published by 2006-10-00 (and the 1990 version of the standard has been withdrawn by this date)

The DOW of the old 60601-1:1990 is defined as 2009-09-12.

The last update of the "higher" (EN 50000 and above) list of harmonized standards was published almost one year ago (2006-07-26).

As I already mentioned in an other posting, I am expecting a new list of harmonized standards soon, so lets just sit and wait... (and there is plenty enough time to put the 3rd edition on the list of harmonized standards until 2009-09-12)

~ghw

[Watchwait]

Publication/withdrawal/harmonization dates aside...I believe I saw a summary of the key differences in the 3rd edition standard. Anyone recall seeing this info?

[mmantunes]

Great timing on the question....Intertek just published some days ago a white paper (based on a webinar they did last year) about the changes..you can download it here: **DEAD LINK REMOVED***