Specifications

5.0 COMPLIANCE VERIFICATION
It is necessary for the assembler to verify compliance. A series of tests, when
performed at the time of installation, will indicate compliance with 21 CFR, Sub-Chapter
J, Part 1020, Performance Standards.
The following tests are from NEMA Standards Publication, No. XR-8-1979 (Test
Methods for Diagnostic X-Ray Machines for Use During Initial Installation).
For each compliance item, there may be a variety of test methods described. Which
method is used will depend on the tester’s experience, availability of equipment, time, or
special requirements of the Eureka Linear Collimator. Any reference to tolerances on
compliance items are referenced directly from 21 CFR, Sub-Chapter J, Regulations.
They do not take into account inaccuracies brought about by the test equipment,
instrumentation, or the human element. These factors must be considered when these
tests are performed and the compliance of the equipment is being determined.
5.1 VERIFICATION OF TESTS TO BE PERFORMED
Test Procedure or Requirement Applicable Paragraph
1. Determination of Half Value Layer XR8/2.09
2. Visual Definition of X-Ray Light Field XR8/2.14
3. Intensity of Light Field Illumination XR8/2.15
4. X-Ray Field/Receptor Center Alignment XR8/2.17
5. Indication of Field Size XR8/2.18
6. X-Ray Field Limitation and Alignment XR8/2.20
RECORD THE RESULTS ON THE RECORD SHEET SUPPLIED AT THE END OF
THIS SECTION
Radiation Warning for Diagnostic X-Ray Systems
X-rays are dangerous for both the operator and others in the vicinity unless established
safe exposure procedures are strictly observed.
The useful and scattered beams can produce serious, genetic or potentially fatal bodily
injuries to any persons in the surrounding area if used by an unskilled operator.
Adequate precautions must always be taken to avoid exposure to the useful beam, as
well as leakage radiation from within the source housing or to scattered radiation
resulting from the passage of radiation through matter.
November 2005 ( 5 - 3 ) Linear MC150-C Collimator