14 AFI41-201 10 OCTOBER 2017
2.16.2. MERC will:
2.16.2.1. Oversee the calibration of diagnostic x-ray systems for bases within their
region and performs PCRI on all x-ray systems not performed locally. (T-2).
2.16.2.2. Annually assess local Medical Maintenance compliance with current
maintenance and calibration/certification standards. Level of assessment will be
determined by the regional MERC based on prior site visits, documentation review, needs
assessment, and local Medical Maintenance training levels, as required. (T-2).
2.16.3. ECN/Serial Number Control of X-Ray Systems. AF activities will establish serial
number control of the following major components: tube housing assemblies, x-ray controls,
x-ray high voltage generators, transformers, collimators, tables, cradles, film changers, chest
stands, fluoroscopic imaging assemblies, spot film devices, image intensifiers, cephalometric
devices, image receptor support devices for mammographic x-ray, and other components
such as video monitors, video camera recorders, film cameras, cine cameras, and digital
systems. Control will be established using procedures in AFMAN 41-216, Defense Medical
Logistics Standard Support (DMLSS) User’s Manual. (T-1).
2.17. Certification of X-Ray Systems.
2.17.1. Medical Maintenance will ensure all components of diagnostic medical x-ray
systems (which includes dental x-ray systems) are certified by the Food and Drug
Administration (FDA), Department of Health and Human Services, and Center for Devices
and Radiological Health (CDRH), IAW 21 CFR, Parts 1000 and 1020. (T-0).
2.17.2. Medical Maintenance will install, certify, maintain, and repair medical x-ray systems
IAW 21 CFR, Part 1020, Radiological Health, and the manufacturer’s instructions.
Personnel who install, adjust, and test diagnostic x-ray systems or their major components,
are classified as assemblers under the provisions of 21 CFR, Part 1020. Within the AF,
personnel holding AFSC 4A251/71/91, or civilian equivalents may act as assemblers. (T-0).
2.17.3. Individuals who install x-ray equipment under contract with the government or under
control of a prime contractor are considered assemblers and are subject to the provisions of
21 CFR, Part 1020. (T-0).
2.17.4. AF assemblers installing equipment within the region of applicability (50 United
States and its territories) will send the original (white copy) of FDA Form 2579, Report of
Assembly of a Diagnostic X-ray System, within 15 days to Center for Devices and
Radiological Health Document Mail Center–WO66-G609, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002. The state agency copy (yellow or electronic copy) will be
forwarded to AFMOA/SGAL, within 30 days of the installation. Medical Maintenance will
retain the pink copy in the EDF for the x-ray system. (T-0).
2.17.5. Contractor assemblers installing equipment will provide the original FDA Form 2579
directly to the CDRH within 15 days of installation, and give the purchaser copy (pink copy)
to the MTF to file in the EDF in the medical equipment maintenance activity. (T-0).
2.17.5.1. The medical equipment maintenance activity forwards a duplicate copy (carbon
or reproduction) of FDA Form 2579 to AFMOA/SGAL within 30 days of installation.
(T- 0).