Safety is our Business
Our dedication to safety begins at 7:00 AM every day of the work week - it is our livelihood. All products in our warehouse are checked on entry and then re-checked on exit. Products drop shipped from our manufacturers directly to your door are brought in randomly and re-tested for safety verification. We continually work with all manufacturers to ensure safety and proper designation.
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The highly anticipated Standard Practice for Marking Medical Devices for Safety in the Magnetic Resonance Environment by American Society for Testing and Materials (ASTM) has arrived.
As recommended by ASTM Intl.; The intent of this practice is to provide needed information about the safety of items in and near MR scanners using a compact and easily recognized set of symbols and terms. The terms MR safe and MR compatible as first defined in 1997 in the FDA draft guidance document, "A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems, have been used to describe the safety of devices in and near MR systems. However, there has been a great deal of confusion surrounding this terminology. An incorrect assumption is often made. Users often incorrectly assume that items labeled MR safe or MR compatible are safe or compatible for any MR environment. MR environments vary in terms of magnetic field strength and RF conditions. This new system eliminates much of that confusion.
MR Conditional - an item that has been demonstrated to pose no
known hazards in a specified MR environment with specified conditions
of use. Field conditions that define the specified MR environment include
field strength, spatial gradient, dB/dt (time rate of change of the magnetic field),
radio frequency (RF) fields, and specific absorption rate (SAR.) Additional
conditions, including specific configurations of the item, may be required.
Non-Magnetic - applies to anything that will not be attracted to a magnet
but may contain minimal amounts of metals or alloys containing iron.
However products that contain Non-magnetic metals when passing
thru the Ferromagnetic Detection System or other similar doorway
scanners may cause the system to alert.
CE Certification - these products comply with the essential requirements
of the relevant European health, safety and environmental protection legislation.
Product NOT marked with a designation have been tested under the past methods and are currently being re-evaluated under the new ASTM Standards. Products will be updated continually.