About MITA Standards:
MITA, through its parent organization, NEMA, is an ANSI-accredited Standards developer. NEMA’s first X-ray standard was published in 1926, meaning that it has been developing medical imaging Standards for more than 90 years. MITA’s Standards development program includes not only development of MITA Standards, but serving as the secretariat for DICOM and three US Technical Advisory Groups to the IEC (SC62B, SC62C and TC87). As an organization, MITA is dedicated to ensuring that Standards continue to meet ever shifting market needs while avoiding conflict and duplication.
MITA utilizes the NEMA Standardization Policies and Procedures Manual.
MITA Technical Advisory Committees:
MITA is the administrator for three USNC Technical Advisory Groups (TAGs) to the IEC:
- SC 62B: Diagnostic Imaging Equipment
- SC 62C: Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry
- TC 87: Ultrasonics
These groups are responsible for the development of the US positions related to technical issues being addressed by these committees and subcommittees. Participation in TAGs is open to all US interested parties. For additional information please contact Carolyn Hull for SC 62B, SC 62C , and TC 87.
MITA Published Standards:
- HN 1 2013
HN 1 2013 Manufacturer Disclosure Statement for Medical Device Security
Consists of the MDS2 form and instructions for completing it. Assists professionals responsible for security-risk assessment in the management of medical device security issues. The information on the MDS2 form is not intended, and may be inappropriate, for other purposes.
NEMA/MITA CSP 1-2016 Cybersecurity for Medical Imaging
Addresses how cyber threats pose a significant risk to patient safety, clinical and business continuity in the practice of medical imaging, and why a combination of people, processes, and technologies is required to mitigate these risks. Originally published November 4, 2015.
NU 1-2012 Performance Measurements of Gamma Cameras
Provides a uniform criterion for the measurement and reporting of gamma camera performance parameters for single and multiple crystal cameras and tomographic devices that image a section or reconstruction image volume, or both.
NU 2-2012 Performance Measurements of Positron Emission Tomographs (PETs)
Provides a uniform and consistent method for measuring and reporting performance parameters of PETs. Included are time of flight and non–time of flight coincidence systems, discrete and continuous detector designs, single and multiple slice devices and multiplanar and volume reconstruction models.
NU 3 - 2004 Performance Measurements and Quality Control Guidelines for Non-Imaging Intraoperative Gamma Probes
Establishes definitions and describes quantitative measurements of performance characteristics and quality control tests for non-imaging intraoperative gamma probes.
NU 4-2008 Performance Measurements of Small Animal Positron Emission Tomographs (PETs)
Proposes a standardized methodology for evaluating the performance of PETs designed for animal imaging. Establishes a baseline of system performance in typical imaging conditions independent of camera design and applies to a wide range of camera models and geometries. Represents a subset of measurements that characterize the performance of PETs for specific imaging tasks typically encountered in small laboratory animal imaging facilities. This subset is deemed to be common across all tomographs existing at the time of publication.
MS 10-2010 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging (MRI)
Defines methods for determining the local SAR of diagnostic MRI radio frequency coils under a specific set of conditions.
MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
Defines methods for determining the gradient-induced electric fields of diagnostic magnetic resonance imaging gradient coils (head and body) under a specific set of conditions.
MS 1-2008 (R2013) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
Describes test methods for measuring the performance of diagnostic magnetic resonance imaging systems under a specific set of conditions, using head and body coils and performing proton imaging. Does not address the use of surface coils, chemical shift imaging or spectroscopy.
MS 12-2010 Quantification and Mapping of Geometric Distortion for Special Applications
Defines test methods for measuring the absolute spatial variation of geometric accuracy within magnetic resonance images. This standard presents the absolute geometric accuracy as a map, graph or table throughout the imaging region rather than as simple figures of merit, such as average or worst-case error.(R2013)
MS 2-2008 Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
Describes a method for determining the maximum percent difference between measured distances in an image and actual corresponding phantom dimensions. Evaluates geometric distortion in three orthogonal planes passing through the center of the specification volume.
MS 3-2008 (R2013) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
Defines a method for measuring image-uniformity performance of diagnostic magnetic resonance imaging systems using single channel volume coils and performing proton imaging. This document does not address the use of surface coils, chemical shift imaging, or spectroscopy.
MS 4-2010 Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging (MRI) Devices
Provides methods for determining the acoustic noise level of an MRI system.
MS 5-2010 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
Describes a method for determining the slice thickness of proton images. Does not address spectroscopy, chemical shift imaging and warped slices.
MS 6-2008 (R2013) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance Imaging (MRI)
Defines methods for evaluating single-channel, non-volume special purpose radio-frequency coils for use with MRI. Both receive-only and transmit-receive coils are included. The system head and body coils, and single-channel volume specialty coils, are excluded, as are coils requiring multiple receiver channels for operation.
MS 8 - (R2000) Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
Describes calorimetric and pulse energy methods of whole-body SAR measurements. Specifies tests for volume RF transmit coils that produce relatively homogeneous RF fields.MS 9-2008 (R2013)
Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images (MRI)
Defines test methods for measuring the signal-to-noise ratio, image uniformity and image non-uniformity of MRIs produced using phased array coils.
- XR 22-2006 (R2014)
Quality Control Manual Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-Field Digital Mammography (FFD…
Defines the minimum set of quality control tests to be applied to a manufacturer’s product labeled for final interpretation of images acquired using an FFDM image-acquisition system.XR 23-2660 (R2014)
Quality Control Manual Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-Field Digital Mammography (FFDM)
Features templates that provide a consistent presentation format and a minimum set of quality control tests that should be included as part of the quality assurance plan of a hardcopy output device (e.g., printer) labeled for final interpretation in an FFDM system.XR 24 2008 (R2014)
Primary User Controls for Interventional Angiography X-Ray Equipment
Offers a unified approach to primary user control function as a means of ensuring that the method of control for interventional x-ray equipment is consistent for all manufacturers.XR 25-2010
Computed Tomography Dose Check
Specifies an equipment feature for CT scanners to produce dose-related notification and alert messages to inform operators prior to scanning if the estimated dose would exceed the preset levels.XR 26-2012
Access Controls for Computed Tomography—Identification, Interlocks, and Logs
Applies to the particular functioning of a CT system (as covered by the scope of IEC 60601-2-44) as it relates to who has access/permission to use the system for clinical or other uses. Includes being able to assign specific permissions to selected uses that are above those needed for daily routine scanning, such as the authorization to save protocols and adds provisions to secure the user interface based on a manual lock. Contains the functionality for use in a facility’s quality assurance program such as capturing operator and patient information as well as information related to saved changes in protocols.XR 27-2013
X-ray Equipment for Interventional Procedures User Quality Control Mode
Applies to x-ray equipment intended to perform interventional procedures and defines a set of minimum set of requirements designed to more easily facilitate quality control at the facility level.XR 28-2013
Supplemental Requirements for User Information and System Function Related to Dose in CT
Identifies uniform and standardized manufacturer's information provided to users of a CT scanner. This information includes perfusion scanning, use of Automatic Exposure Control, organization of dose-related information, a requirement for listing the reference protocols shipped on a CT system.XR 29-2013
Standard Attributes on CT Equipment Related to Dose Optimization and Management
Identifies four key features of CT scanners which contribute to or help perform optimization and or management of doses of ionizing radiation while still enabling the system to deliver the diagnostic image quality needed by the physician.XR 30-2016
Quality Control Tools for Digital Projection Radiography
Defines a set of minimum equipment requirements that facilitate the quality control of digital projection radiography by healthcare providers.XR 31-2016
Standard Attributes on X-ray Equipment for Interventional Proceeds
Offers healthcare providers a reference to identify key features which contribute to enhanced patient care and to help manage patient radiation dose delivery, while still enabling the system to provide sufficient image quality needed by the physician.
- UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3
Covers all active ultrasound apparatus designed for medical diagnostic use, including ultrasonic echo ranging devices (both manual and automatically scanned), through-transmission devices, Doppler echo equipment and combinations thereof.