900.12(b)(5): For any mammography system with a light beam that passes through the X-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 foot candles) at 100 cm or the maximum source-image receptor distance (SID), whichever is less.
- Does FDA have illumination requirements applicable to the collimator light on mammography x-ray systems? If so, do they apply to all systems?
- Who is responsible for performing the light beam test? How often should it be tested and by what method?
- Is there any specified minimum or maximum SID?