May 16 2014 Official Journal of the European Union Publication - 60601-2-33
- Thread starter Kaosk8e
- Start date
I cannot find anything to explain this.
I did notice that the 2010 version of the standard (MRI) has been amended and replaced by a 2013 version, in the IEC webstore.
To speculate:
it could be that the earlier version has been removed, with the plan being that the new version would replace it. However, the new version may have been blocked from OJ publication, by objections. These have affected other standards, with the objections being that the new standard "does not necessarily show compliance with all of the Essential Requirements of the MDD".
These difficulties seem to be occurring as the responsibility for the management of the MDD has been transferred within the European Commission.
I did notice that the 2010 version of the standard (MRI) has been amended and replaced by a 2013 version, in the IEC webstore.
To speculate:
it could be that the earlier version has been removed, with the plan being that the new version would replace it. However, the new version may have been blocked from OJ publication, by objections. These have affected other standards, with the objections being that the new standard "does not necessarily show compliance with all of the Essential Requirements of the MDD".
These difficulties seem to be occurring as the responsibility for the management of the MDD has been transferred within the European Commission.
U
usability
Kaosk8e
I have received following explanation from EC.
EN 60601-2-44:2009 and EN 60601-2-54 were not included in the previous list of harmonised standards due to certain mistakes occurring with the CEN/CENELEC database. As you write in your email, these standards have been regularly reinstated in the latest publication of harmonised standards for medical devices, in January 2015.
Regarding EN 60601-2-33, a similar problem as the one described above occurred and we will be in a position to correct it in the context of the next publication of the Official Journal, which should be launched in Spring 2015.
I have received following explanation from EC.
EN 60601-2-44:2009 and EN 60601-2-54 were not included in the previous list of harmonised standards due to certain mistakes occurring with the CEN/CENELEC database. As you write in your email, these standards have been regularly reinstated in the latest publication of harmonised standards for medical devices, in January 2015.
Regarding EN 60601-2-33, a similar problem as the one described above occurred and we will be in a position to correct it in the context of the next publication of the Official Journal, which should be launched in Spring 2015.
