Directive 2004/40 / EC1 concerning the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields).
It aims to introduce limits to protect workers exposed in the course of their work, to risks arising from electromagnetic fields. But it was not taken into account in this Directive
the use of electromagnetic fields in medicine and especially in magnetic resonance imaging. Within the limits set by the directive, doctors and nursing staff who use MRI machines
could no longer work in legal conditions. In most European countries, scientific organizations and learned societies in the field of imaging and health have requested a postponement
of the transposition of the Directive into national law (the deadline is April 2008), as well as an amendment to this Directive to take into account the particularities and benefits of MRI.
DIRECTIVE 2013/35/EU OF THE EUROPEAN PARLIAMENT
The European Directive on electromagnetic fields (EMF ) originally scheduled for April 2012 has been postponed to October 2013. The new European directive on workers' exposure to
electromagnetic fields has just been voted the European Directive 2004/40 / EC April 29th, 2004 has been replaced by Directive 2013/35 / EU . This Directive lays down minimum
safety and health requirements for workers exposed to electromagnetic fields. In April, the Council and the European Parliament reached an agreement on the draft directive .
On June 11 the Parliament and adopted on June 29 , the Cabinet validated . Member States have until 1 July 2016 to transpose it/
ASTM F2503 norm
The new terminology used by medical device manufacturers to test and identify the ASTM F2503 products, Standard Practice for Marking Medical Devices and Other Items
for Safety in the Magnetic Resonance and the current recommendation guides FDA gives I uniform system for identifying conditions for each MRI medical device.
MRI of the labels and icons for each of the terms reduce patient risk when potentially dangerous devices into the environment of MRI. The standard terminology is:
MRI safe: Article non-conductive, non-magnetic and non-metallic such as plastic and poses no risk in all environments of MRI MRI safe under certain conditions used
for an article that poses no known hazard in a specific MRI environment with the specific operating conditions. The conditions which define I MRI environment include
the power of the static magnetic field, radio frequency waves, the specific absorption rate, artifact distortion around I'image. For such systems, the label of the
device comprises the results of tests of the behavior of the article in MRI environment.
Specific terms were chosen to designate the different situations encountered in everyday practice
1997 terminology of the US Food and Drugs Administration (FDA)
Confusion between "MR safe " and " MR compatible"
2005: new terminology of the American Society for Testing and Materials (ASTM F2503 ) :