This alternative standard was approved on June 16, 2005. It covers the system artifact testing various target filter combinations. The approved alternative permits the system artifact test to be performed without testing all target filter combinations during the annual physics survey.
The alternative standard covers any facility that elects to apply it and meets the conditions described below. The alternative was approved for an indefinite period.
The original standard states:
21 CFR 900.12(e)(5)(ix): System Artifacts. System artifacts shall be evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and shall be performed for all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. System artifacts shall also be evaluated for all available focal spot sizes and target filter combinations used clinically.
The granted alternative is:
21 CFR 900.12(e)(5)(ix): System Artifacts. System artifacts shall be evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and shall be performed for all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. System artifacts shall also be evaluated for all available focal spot sizes, targets, and filters used clinically.
Conditions of this alternative requirement are:
• The alternative is granted when testing for the annual physics survey only
• When following the alternative, if any filter-related artifact is discovered during the test then all clinically used target filter combinations as specified under the current regulation must be tested
• When conducting a mammography equipment evaluation (MEE), all clinically used target filter combinations must be tested