Harmonization date of IEC 60601-1 , 3rd Edition

Marcelo · Nov 25, 2009

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

Now you made me curious. Why would it "legally" be 2012? There´s no date yet in the official journal for the geranal standard or 2012. The only dates are for particulars. So legally we would need to address these dates which are already referenced.

Also, toumean that the Q&A (which is an official interpretation of the regulations from CENELEC) are incorrect?

mark walker · Nov 25, 2009

This is an extract from minutes of recent CENELEC meeting. I hope it clarifies…
EN 60601 series date of presumption of conformity
The content of the Chairman’s report in TC62/SEC1013/MTG was noted.
Following detailed discussion it was agreed:
Decision 1: TC 62 considered Decision 7 of the last meeting and the proposal
circulated in CLC/TC 62 1008/INF. TC 62 agreed to revise Decision 7 so that for
EN 60601-1, 2nd edition and its collaterals the date of cessation of the
presumption of conformity (listing in the OJ) shall be 2012-06-01 (to be
confirmed with CLC/CS, and to be approved by CLC/BT).
The following wording in the present forewords is to be deleted (example for
main document):
"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conjunction with it have been withdrawn.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."
Dear James,
This is an extract from minutes of recent CENELEC meeting. I hope it clarifies…
EN 60601 series date of presumption of conformity
The content of the Chairman’s report in TC62/SEC1013/MTG was noted.
Following detailed discussion it was agreed:
Decision 1: TC 62 considered Decision 7 of the last meeting and the proposal
circulated in CLC/TC 62 1008/INF. TC 62 agreed to revise Decision 7 so that for
EN 60601-1, 2nd edition and its collaterals the date of cessation of the
presumption of conformity (listing in the OJ) shall be 2012-06-01 (to be
confirmed with CLC/CS, and to be approved by CLC/BT).
The following wording in the present forewords is to be deleted (example for
main document):
"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conjunction with it have been withdrawn.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."
Dear James,
This is an extract from minutes of recent CENELEC meeting. I hope it clarifies…
EN 60601 series date of presumption of conformity
The content of the Chairman’s report in TC62/SEC1013/MTG was noted.
Following detailed discussion it was agreed:
Decision 1: TC 62 considered Decision 7 of the last meeting and the proposal
circulated in CLC/TC 62 1008/INF. TC 62 agreed to revise Decision 7 so that for
EN 60601-1, 2nd edition and its collaterals the date of cessation of the
presumption of conformity (listing in the OJ) shall be 2012-06-01 (to be
confirmed with CLC/CS, and to be approved by CLC/BT).
The following wording in the present forewords is to be deleted (example for
main document):
"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."

Hope this clariffys things

Marcelo · Nov 25, 2009

Mark (sorry, i wrongly called you James innitially) what you showed is the decision of modyfying the date on the body of EN 60601 (which will be "translated" in the official journal later).

Two things:

1 - it relates to devices which do not have applicable particular standards. The case we´re discussing in this threadis for devices which have particular standards (in the case, diagnostic US, ECG, etc).So this date does not apply to them, what applies is the information i quoted from the Q&Q.

2 - this decision has not yet been published in the pofficial journal, it is still an internal decision of CENELEC. As i told you, the only officialrregulatory information we have today is that there´s no date for the third edition (for devices which ONLY the general standard applies) and there´s dates for devices which have to apply particulars. So, until the revised date is published on the official journal, device which onçy the genral applies do not have the 2012 target date. And even when it´s published, it won´t change the problem with particular (my expectation, and of others, is that the next publication revises the wrong dates).

recruit · Nov 26, 2009

mark walker said:
No Part2 are enforcable until part 1 acceptance in june 2012

Hi, Mark. Is your conclusion from official news?

recruit · Nov 26, 2009

mmantunes said:
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.:

I discussed with my NB about 2-37. The NB insist that diagnostic ultrasound devices have to comply third general standard and 60601-2-37:2008 after Oct 2010.

mmantunes said:
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.:

I also asked NB the case. NB's opinion is that the devices have to comply both version at the same time. It's so rigorous. I don't know other NBs how to consider the case.

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

Since last OJ have a lot of errors, when will it be updated rightly?

mark walker · Nov 26, 2009

Hi Again. The thread i sent you does effectively say when yo apply third editioin only the date is still going to be 2012. Additionally the most countries will require 2nd and 3rd edition compliance for the foreseable future.

Marcelo · Nov 26, 2009

Hello recruit, thanks for for getting an input from a NB.

I discussed with my NB about 2-37. The NB insist that diagnostic ultrasound devices have to comply third general standard and 60601-2-37:2008 after Oct 2010.

That´s right, according to the Q&A that´s what will have to happen. If there´s a particular aligned with the third edition already harmonized and with a date you will have to comply with the third edition and the particular after that date.

I also asked NB the case. NB's opinion is that the devices have to comply both version at the same time. It's so rigorous. I don't know other NBs how to consider the case.

This is weird. First, this situation is not dealt in the Q&A. Second, Compliance with both standards, in some cases, is not possible, due to some technical moficiations on some of the particulars which have been made when aligining them with the third edition. Third, this is NOT what usually happens when you have two similar standards in the list of hamonised standards; what usually happens is that you simply choose what best fits your case (also note that you CAN in the majority of cases be in compliance with both if you deal with the discrepancies thru risk management).

Since last OJ have a lot of errors, when will it be updated rightly?

I don´t know, this is a decision of the European Comission and have to go thru bureaucratic steps which might take a little. Also note that this new revision is expected to included the information provided by Mark (meaning, dates for devices which only the general standard - and obviously collaterals, which aqre part of the general standard -applies)

mark walker · Nov 27, 2009

Again our NB SGS/TUV/Semko have again said june 2012. The only grey area is the application of collateral standards which i have been informed by my colleagues from IEC/3rd Edition standards commitees that we should apply now. ELEKTA is a very big player regarding standards and very influencial. We are developing many new technonogy standa=ds with IEC approval as we speak.

Marcelo · Nov 27, 2009

i have been informed by my colleagues from IEC/3rd Edition standards commitees that we should apply now

The application of IEC 60601-1 is separated from the development of the standard. IEC TC 62 produces the standards, but what requires their use is the regulatory systems of each country. With this in mind, members of the IEC TC 62 committee saying that standards should be applied now is an overstatement, because IEC does not dictate the use of the standards, and also because.

Please note that i say this because I, myself, am a member TC 62, representing Brazil. And I would never say such a thing.

Again our NB SGS/TUV/Semko have again said june 2012.

Now i´m a little confused because i don´t know to exactly what you´re refering to.

ELEKTA is a very big player regarding standards and very influencial. We are developing many new technonogy standa=ds with IEC approval as we speak.

Congratulations on your company participation in standard development activites, but please keep in mind that some users of the Cove also participate in standards development activites in IEC and ISO. For example, apart from myself, Mike Schmidt, which pposts in this thread sometimes, is the secretary of IEC 62 D, responsible in this case for the development os a lot of particulars from the IEC 60601 series.

mark walker · Nov 27, 2009

Hi Marcelo,

You should know but there are many mixed messages and inconsistancies from IEC committees and as you know we have various transitional periods.

With emerging countries still only expting 2nd edition compliance its more likely that it will be 2012 by the time we habve global acceptance eg China have only just accepted 2nd edition. FDA only want to except electrical clause of 60601-1

Harmonization date of IEC 60601-1 , 3rd Edition

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