C
I'm a newbie on the field of medical standards, and I have a little confusion about an ongoing EMC test.
The product is an ECG Holter, marketed in manly in EU and Japan, and a member of the test facility wrote that he's certificating our product according to EN 60601-1-2:2007 and EN 80601-2-47:2010.
Well I haven't found EN 80601-2-47:2010. But we used EN 60601-2-47:2001, which we think we need as it is about ambulant products. Was it a typo? (I will contact with him, I just want to make sure before asking stupid questions)
The second confusion point is the same standard, the EN 60601-2-47:2001 - which I think is valid today - is referring to IEC 60601-1-2:1993. But there are newer versions of the latter (we use EN 60601-1-2:2007), and the points are not perfectly matching. It's kinda strange for me... I've searched around a lot, and found that there is a new version of the IEC 60601-2-47, published in february 2012. As far as I know, the harmonization of this standard is undergoing now by the EU and CENELEC.
My question and asks are:
- Was I correct in the aboves - dates, valid standards, etc?
- Should we use the IEC 60601-2-47:2012 or the EN 60601-2-47:2001?
- Can you give me some clarification about all this to see clear?
Thank you for your help, it's really appreciated as I'm quite new to the world of medical standards!
p.s. It's kinda interesting too, that an ambulant holter, which is recording 24h ECG signal usully, have to confirm such strict standard, particuraly 3V/m 80-1000MHz /according to 60601-2-47:2001/ without significant distortision in (such a low voltage) signal /according to 60601-1-2)/. I mean, if the user doesn't keep the 2,5 meter distance in case of a cell phone (3V/m) or crossing an EMI source and the recorder losses 30 minutes maximum, there will be 23,5 hours of good measurement. Of course we are designing to pass it easily (as a user won't keep that distance) but it looks a little bit to strick at first glance.
The product is an ECG Holter, marketed in manly in EU and Japan, and a member of the test facility wrote that he's certificating our product according to EN 60601-1-2:2007 and EN 80601-2-47:2010.
Well I haven't found EN 80601-2-47:2010. But we used EN 60601-2-47:2001, which we think we need as it is about ambulant products. Was it a typo? (I will contact with him, I just want to make sure before asking stupid questions)
The second confusion point is the same standard, the EN 60601-2-47:2001 - which I think is valid today - is referring to IEC 60601-1-2:1993. But there are newer versions of the latter (we use EN 60601-1-2:2007), and the points are not perfectly matching. It's kinda strange for me... I've searched around a lot, and found that there is a new version of the IEC 60601-2-47, published in february 2012. As far as I know, the harmonization of this standard is undergoing now by the EU and CENELEC.
My question and asks are:
- Was I correct in the aboves - dates, valid standards, etc?
- Should we use the IEC 60601-2-47:2012 or the EN 60601-2-47:2001?
- Can you give me some clarification about all this to see clear?
Thank you for your help, it's really appreciated as I'm quite new to the world of medical standards!
p.s. It's kinda interesting too, that an ambulant holter, which is recording 24h ECG signal usully, have to confirm such strict standard, particuraly 3V/m 80-1000MHz /according to 60601-2-47:2001/ without significant distortision in (such a low voltage) signal /according to 60601-1-2)/. I mean, if the user doesn't keep the 2,5 meter distance in case of a cell phone (3V/m) or crossing an EMI source and the recorder losses 30 minutes maximum, there will be 23,5 hours of good measurement. Of course we are designing to pass it easily (as a user won't keep that distance) but it looks a little bit to strick at first glance.
Last edited by a moderator: