ASTM F2503-08 PDF

Does anyone know of a test house/laboratory in the UK that does MR deflection testing (i.e. at 3 Tesla) to ASTM F? Found places in. Materials (ASTM) International (for- merly the American . terms defined in ASTM F (released in August .. Designation: F, stan-. The new terms defined in ASTM F (released in August ) and .. and Materials (ASTM) International, Designation: F, Standard Practice for.

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Specific testing and labeling for active implants e. Any parameter that affects the safety of the item should be listed and any condition that is known to produce an unsafe condition must be described.

Additional conditions, including specific configurations of the item e.

New ASTM F2503 2013 Edition released for Marking Medical Devices

Enter your personal account astmm address to request a password reset: FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. Labeling information for implants ast other medical devices has been compiled and is available in published and on-line formats 2, American Journal of Roentgenology ; The FDA also recommends that the patient register the conditions under which their MR Conditional implant can be scanned safely with the MedicAlert Foundation or other equivalent organization, and so the device labeling may include contact information for MedicAlert Notably, the point of the highest spatial magnetic gradient is the position where translational attraction i.

These terms were defined, as follows 6: Statements such as “intended for use in the MR environment” or similar claims along with appropriate qualifying information are preferred i. When manufacturers make a submission to FDA for an existing device, FDA requests the manufacturers of these previously approved devices update their labeling to use the new MR safety terminology.


No other units of measurement are included in this standard. The magnetic resonance MR environment may pose risks or problems to patients with certain implants and other medical devices primarily due to factors that include electromagnetic field interactions, MRI-related heating, and the creation of artifacts It is recognized that direct marking on the item is not practical for implants and certain other medical devices.

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MR Unsafe items include magnetic items such as a pair of ferromagnetic scissors. Therefore, the goal of this Editorial is to present background information about the terms used for MRI labeling of implants and other medical devices, to define the current terms, and to illustrate the use of the new labeling by providing a sample label with a detailed explanation of how the terminology is used. Thus, over the years, test methods have been developed by various organizations including the American Society for Testing and Materials ASTM International formerly the American Society for Testing and Materialswith an ongoing commitment to ensure patient safety in the MR environment The MR system manufacturer is able to provide spatial gradient magnetic field information for a particular MR system or it may determined using a Gauss meter.


This is a common statement for many different implants and devices. This term indicates that the device, when used in the MR environment, has been demonstrated to present no additional risk to the patient, but may affect the quality of the f2530-08 information. Safety of magnetic resonance imaging in patients with cardiovascular devices: Print 1 2 3 4 5 page sstarting from page current page. It can be scanned safely under the following conditions: These icons are intended for use on items that may be brought into or near the MR environment as well as in product labeling for implants and other medical devices.


Copyright Compu-tecture, Inc. For MR Conditional items, the item labeling includes results of testing sufficient to characterize the behavior of the item in the MR environment.

Register for a trial account. If you like to setup a quick demo, let us know at support madcad. The labeling for the implant has additional information with respect to the temperature xstm that is associated with certain MRI parameters, that is based on the findings obtained in the MRI-related heating test. Standards for medical devices in MRI: COM web site should be addressed to: The following editions for this book asttm also available It should be noted that, in this labeling section, certain labels for implants and other medical devices may state that this information applies to the use of a particular type of transmit RF coil that should be used, such as a transmit body or transmit head RF coil.

Medical Electrical Equipment–Part 2: