W
Watchwait
Hello Marcelo.
Amazing how this topic continues to generate interest. One would think by now that any/all questions thast could be asked/answered would already have been done so. Alas!
OK - my specific question regarding 3rd edition has to do with collateral standards. In addition to 60601-1 3rd Edition, are there any revisions to the 60601 collateral standards who's effectivity is scheduled to be coincident with the parent 60601-1 June, 2012 timeline?
We have new products scheduled for release in the next 12 months with requirements to conform with 60601-1 3rd Edition. But if there are other collateral standards also being revised with this same timelinne we need to know about it sooner rather than later.
Hope the answer to this question might help others in similar situations.
Amazing how this topic continues to generate interest. One would think by now that any/all questions thast could be asked/answered would already have been done so. Alas!
OK - my specific question regarding 3rd edition has to do with collateral standards. In addition to 60601-1 3rd Edition, are there any revisions to the 60601 collateral standards who's effectivity is scheduled to be coincident with the parent 60601-1 June, 2012 timeline?
We have new products scheduled for release in the next 12 months with requirements to conform with 60601-1 3rd Edition. But if there are other collateral standards also being revised with this same timelinne we need to know about it sooner rather than later.
Hope the answer to this question might help others in similar situations.
T
TaraMedical
Hello - I went back to my colleagues with the question on Collateral standards, and they told me about this IECEE table "Use of collateral standards in the IECEE system for 2nd and 3rd Editions of IEC 60601-1"
(broken link removed)
I hope this helps.
Last edited by a moderator:
Hi Tara,
The quoted document is with respect to test labs working in the CB scheme. For a manufacturer this is irrelevant. Thier key concern is the harmonisation dates associated with collateral standards in Europe.
The situation for collaterals is complicated as it can depend on particular standards. It is also a bit messy as some of the collaterals were absorbed into the general standard (601-1-1, 601-1-4).
As far as I can tell, if for your case EN 60601-1:2006 will be applicable on June 1, 2012 then the following collaterals should also be applied (as applicable) at the same time:
EN 60601-1-2:2007 (EMC)
EN 60601-1-3:2008 (X-ray related)
EN 60601-1-6:2004 (Ergonomics)
EN 60601-1-8:2007 (Alarms)
EN 60601-1-10:2008 (Closed loop physiological controllers)
EN 60601-1-11:2010 (Home use medical devices)
Hope this helps.
The quoted document is with respect to test labs working in the CB scheme. For a manufacturer this is irrelevant. Thier key concern is the harmonisation dates associated with collateral standards in Europe.
The situation for collaterals is complicated as it can depend on particular standards. It is also a bit messy as some of the collaterals were absorbed into the general standard (601-1-1, 601-1-4).
As far as I can tell, if for your case EN 60601-1:2006 will be applicable on June 1, 2012 then the following collaterals should also be applied (as applicable) at the same time:
EN 60601-1-2:2007 (EMC)
EN 60601-1-3:2008 (X-ray related)
EN 60601-1-6:2004 (Ergonomics)
EN 60601-1-8:2007 (Alarms)
EN 60601-1-10:2008 (Closed loop physiological controllers)
EN 60601-1-11:2010 (Home use medical devices)
Hope this helps.
thisby_
Involved In Discussions
Hello,
my company is now in the process of sending a device to the UL so it can prove compliance with IEC 60601-1, we were told by UL that we should ask for compliance with IEC 60601-1 3rd edition. The UL labs also told us that there will be a 2 years period after the 3rd edition will start to be used while manufactures need to "adapt" their products to 3rd edition. Does this mean that ALL medical devices in the hospital compliant with IEC 60601-1 2nd edition will have to be re-tested to show compliance with IEC 60601-1 3rd edition?!
The UL also told us that a 2nd edition device cannot be connected to a 3rd edition device. Why is that? (I didn't read the 3rd edition yet, so if someone can give some inputs in the meantime I would appreciate that very much!)
Thank you!
Emilia
my company is now in the process of sending a device to the UL so it can prove compliance with IEC 60601-1, we were told by UL that we should ask for compliance with IEC 60601-1 3rd edition. The UL labs also told us that there will be a 2 years period after the 3rd edition will start to be used while manufactures need to "adapt" their products to 3rd edition. Does this mean that ALL medical devices in the hospital compliant with IEC 60601-1 2nd edition will have to be re-tested to show compliance with IEC 60601-1 3rd edition?!
The UL also told us that a 2nd edition device cannot be connected to a 3rd edition device. Why is that? (I didn't read the 3rd edition yet, so if someone can give some inputs in the meantime I would appreciate that very much!)
Thank you!
Emilia
M
mark walker
Hi There USA UL will only require third edition at around june 2013 FOR USA PRODUCTS. Canada, Europe etc its june-sept 2012. If your device is for the world market you will require 2nd and 3rd edition compliance from june-sept 2012.
Regards
Mark
Regards
Mark
Compliance is generally only related to premarket, meaning devices already on the market do not need to be changed because they were in compliance when sold.
Don´t know why it could not. Seems like a weird statement to me.
In the US and Canada there is no immediate regulatory expectation for manufacturers to update to new standards for existing devices. In fact, standards in the US and Canada have no legal status, they only have relevance at the time you make an application for 510(k), PMA or device licence.
In Europe the situation is different. Standards are tied in with the regulation. Most notified bodies expect manufacturers to update to new standards at the end of a transition period; although this is open to argument as to whether this is really necessary considering not very well known preliminary comments in the regulation (whereas statements).
UL's mark is a private mark as well as an NRTL/SCC mark. So there are two factors for UL to consider: their own private transition period, and also the date at which UL 60601-1:2003 will be withdrawn from the list of NRTL standards and CSA 22.1 601-1 from SCC standards. I believe there are no dates set yet for any of these actions.
The situation is so complicated that UL may be just taking a global view when providing the recommendation to use the 3rd edition, and to update older devices.
In Europe the situation is different. Standards are tied in with the regulation. Most notified bodies expect manufacturers to update to new standards at the end of a transition period; although this is open to argument as to whether this is really necessary considering not very well known preliminary comments in the regulation (whereas statements).
UL's mark is a private mark as well as an NRTL/SCC mark. So there are two factors for UL to consider: their own private transition period, and also the date at which UL 60601-1:2003 will be withdrawn from the list of NRTL standards and CSA 22.1 601-1 from SCC standards. I believe there are no dates set yet for any of these actions.
The situation is so complicated that UL may be just taking a global view when providing the recommendation to use the 3rd edition, and to update older devices.
thisby_
Involved In Discussions
First of all thank you all of you for the great inputs.
I am concerned about this because we already have a device on the market, 2nd version compliant, which is used to get data from medical devices and send it to the EMR/CIS. When the UL said to us that a 2nd edition devices cannot be connected to 3rd edition devices this worried us. Should we upgrade our device to 3rd version? Consider that the device is already in the US market and is FDA approved.
We will soon want to be able to sell it in europe as well, do we need the 3rd edition compliance to have the CE mark if we do it before the end of this year? Will we have to "upgrade" it later anyhow?
Thank you again,
Emilia
I am concerned about this because we already have a device on the market, 2nd version compliant, which is used to get data from medical devices and send it to the EMR/CIS. When the UL said to us that a 2nd edition devices cannot be connected to 3rd edition devices this worried us. Should we upgrade our device to 3rd version? Consider that the device is already in the US market and is FDA approved.
We will soon want to be able to sell it in europe as well, do we need the 3rd edition compliance to have the CE mark if we do it before the end of this year? Will we have to "upgrade" it later anyhow?
Thank you again,
Emilia
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