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.

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