Standards

News/Announcements:

NEMA XR 24
Primary User Controls for Interventional Angiography X-ray equipment
Withdrawal information for stakeholders

NEMA/MITA standards are reviewed every five years to ensure that their content continues to be relevant and technically sound. Following formal review of NEMA XR 24 by the MITA X-Ray Section and its Interventional Group, the recommendation is to withdraw NEMA XR 24, Primary User Controls for Interventional Angiography X-ray equipment.  MITA intends to withdraw the standard by the end of 2017.

The reasons of that recommendation are as follows:

  • The standard was originally published in 2008 and has not been revised since.
  • XR 24 is prescriptive and specifies design requirements which limits new technology (e.g., wireless, tablet, etc.) and may not allow for modern design considerations to meet the standard.
  • The current IEC 60601-2-43:2010 and its upcoming amendments 1 and 2 also address user interface requirements for patient and operator safety (e.g., table side controls), and having duplicative or conflicting standards is counterproductive.
  • If interest exists from stakeholders, MITA would be willing to continue the dialogue and coordination to ensure that important content is retained without duplicating efforts of the IEC maintenance team (MT 41).

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 Cassie Ricci for SC 62B or SC 62C or Andrew Northup for TC 87.

MITA Published Standards:

MITA STANDARDS UNDER DEVELOPMENT:

New Standards and White Papers:

  • ANSI/MITA 2, Requirements for Servicing of Medical Imaging Equipment (contact Peter Weems)
  • ANSI/MITA 3, Symbols for Medical Imaging (contact Megan Hayes)
  • MITA WP 2, Modification of Display Systems for Medical Imaging Equipment (contact Megan Hayes)
  • MITA WP 1, Computed Tomography Image Quality (CTIQ): Low Contrast Detectability (LCD) Assessment when Using Dose Reduction Technology
  • Coil Heating for Magentic Resonance

Revisions:

  • Medical Imaging Informatics
    (contact Peter Weems)
    ANSI/HN 1, Manufacturer Disclosure Statement for Medical Device Security
  • Magnetic Resonance
    (contact Andrew Northup)
    MS 10, Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
    MS 4, Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Images
    MS 5, Determination of Special Purpose Coils for Diagnostic Magnetic Resonance Images
  • Molecular Imaging
    (contact Sue Bunning)
    NU 1, Performance Measurements for Gamma Cameras
    NU 2, Performance Measurements of Positron Emission Tomographs (PETs)
  • X-Ray
    (contact Megan Hayes)
    XR 25, Computed Tomography Dose Check
    XR 26, Access Controls for Computed Tomography—Identification, Interlocks, and Logs

MITA is the secretariat for Digital Imaging and Communication in Medicine, the international standard for medical images and related information. For information about DICOM standards development efforts, please visit the DICOM website.