Harmonization date of IEC 60601-1 , 3rd Edition

Particular standards are created to "modify" horizontal standards including the General & Collaterals. This means (in the case you cite for OR Tables) that where there is a conflict, the requirements of the particular standard apply.

Click to expand...

Yes, that's a given. The problem with -2-46 all along has been that it was drafted around core assumptions as to the product's load rating and load distribution, but (1) those assumptions were not clearly stated, therefore the exact meaning of their superposition over the -1 standard was a matter of interpretation and/or not universally recognized, and (2) no interpretation within the bounds of the stated wording allowed for products with significantly greater load ratings than what -2-46's drafters apparently thought were the norm, thus application of the standard to real marketable products required a stated deviation from the standard's requirements.

Another option would be to continue using the 2nd edition of 60601-1 with the old particular.

Click to expand...

Actually the problem was worse with 2nd Edition. As I noted before, 3rd Edition was a big improvement over 2nd Edition in regard to patient-load structural issues.

Hi Mike,

Thanks for that!

Do you have any spreadsheets that you could advise we use for considering risk management requirements in relation to the third edition?

Mark

The recent decision (October 2009) of the CENELEC/BT regarding the date of withdrawal associated with EN 60601-1:2006

BT agreed to associate a date of withdrawal (2012-06-01) with EN 60601-1:2006 and its collaterals and invites CS to issue the relevant corrigenda.

As a consequence,
- BT agreed to the deletion of the following wording in the present forewords of EN 60601-1:2006 and its collaterals:
“However, EN 60601-1:1990 remains valid until all parts 2 that are used in conjunction with it have been withdrawn. No date of withdrawal of conflicting national standards (dow) has therefore been fixed. However, when Part 1 is used for appliances not covered by a part 2, EN 60601-1:1990 is not to be used after 2009-09-12.” and asked CS to issue the relevant corrigenda.​

New post on the Cenelec website about the third edition series and the EU medical devices directives:

(broken link removed)

Is there a published projected timetable for revisions to -2 parts...and perhaps a listing of those -2 parts that will be discontinued rather than revised, and/or info on changes to titles and scope definitions?

My particular focus is -2-46 "Operating Tables". I need to determine our structural-engineering compliance approach for radiographic tables that might or might not be interpretable as meeting an "operating" definition. This problem exists in the context that the existing -2-46 is in some ways inexpert regarding its subject matter, and mostly describes radiographic tables, not operating tables, notwithstanding its title.

-1 Third Edition by itself is greatly superior to the combination of -1 Second Edition plus the existing -2-46, from the perspective of consistency with sensible engineering decisions to create a marketable, technical-state-of-the-art product...but the possibility that a new -2-46 could incorporate scope changes or new definitions or rules is a black hole from a regulatory planning perspective.

The original projected timetable was that at the end of 2009 all particulars were aligned with third edition. Obviously, this could not be accomplished. There´s a new expectancy that the majority of standards will be aligned at the end of 2010, but this will also not be possible (some particulars have just had their CD circulated...for the ones from IEC 62D, please see (broken link removed))

From this page, you can see that in general at the end of 2010 or beginning 2011 almost all old particulars should be harmonized.

I haven´t updated my data, but as far as i remember, no particular will be discontinued.

Finally, regarding 2-49, it will have some technical changes, mainly to align the new mechanical requirements of the third edition. But the scope and definitions remais the same, at least at the present circulated CDV (the definition of operating table changed, but essentially it´s the same).

I have a special situation.
My company produces ultrasound diagnositc products. In OJ, EN60601-2-37:2008 aligned with third 60601-1 has been harmonized. The DOCOPOCOSS is 2010-10-1. My NB required that our products must comply third 60601-1 and EN60601-2-37:2008 after Oct 2010. Is it reasonable?

Back to this kinds of products, we have to consider EN60601-2-25：1995+A1:1999 or EN60601-2-18：1996+A1:2000 for the system if optional ECG function or Trans-esophageal transducer is added. But both part standards yet are aligned with the third standard. In the case, whether second or third IEC60601-1 should the system comply with?

My situation should be common for companies producing ultrasound diagnositc devices. Whoever can share good solution?

No Part2 are enforcable until part 1 acceptance in june 2012

My company produces ultrasound diagnositc products. In OJ, EN60601-2-37:2008 aligned with third 60601-1 has been harmonized. The DOCOPOCOSS is 2010-10-1. My NB required that our products must comply third 60601-1 and EN60601-2-37:2008 after Oct 2010. Is it reasonable?

Click to expand...

As described in the question and answers (see link above), particular already aligned have to comply after the DOCOPOCOSS. However, the last list of harmonized standards is know to have some wrong dates. I would suggest you ask youo notified body for more clarifications regarding 2-37.

Back to this kinds of products, we have to consider EN60601-2-25：1995+A1:1999 or EN60601-2-18：1996+A1:2000 for the system if optional ECG function or Trans-esophageal transducer is added. But both part standards yet are aligned with the third standard. In the case, whether second or third IEC60601-1 should the system comply with?

Click to expand...

These cases where there´s more tha one patrticular involved, and some are and some are not yet aligned, have to be dealt,in my opinion, on a case by case basis. Again, you shpuld discuss it with your NB and they should query the appropriate authorities if needed.

No Part2 are enforcable until part 1 acceptance in june 2012

Click to expand...

This is wrong, the Q&A clearly states the contrary:

If the transition period of the part-2 ends on, for example, 21 November 2011 then, after this date, compliance with the old standard no longer gives the presumption of conformity with the Essential Requirements.

Click to expand...

Thats incorrect as legally the 2012 cut off point still stands. Agreed it would be positive to achieve this in 2011 but not essential