New diagnostic x-ray system performance standards

Just learned today that the FDA issued the latest revisions to 21 CFR Part 1020, which outlines FDA standards for how diagnostic x-ray machines should perform.

Haven't had a chance to go through it yet, but glancing through the summary, I see a few notable changes:

  • Switch to using KERMA and air KERMA for exposure measurements
  • Changes to minimum HVL requirements
  • Last image hold requirement
  • Dose information display to the operator

It's a long 46 page document that will probably take a while to go through, but the summary provides references to the sections that changed so there's probably no need to wade through all of it. Some of the comments might be interesting though.