DATE ON REPORT OF CALIBRATION FOR ATOMLAB DOSE CALIBRATOR
SIGNIFICANCE AND EXPIRATION
The Report of Calibration that accompanies the Atomlab Dose Calibrator is intend-
ed to represent evidence that the product was calibrated by the manufacturer
before it was shipped. This report does not serve as an exemption to the accuracy
test that is required at installation of the product in the facility where it will be used.
The date on the Report of Calibration does not expire
since the report is not
useful, in the typical sense, as a record of calibration in a periodic maintenance
schedule.
For example, when a survey meter is purchased, it normally comes with a calibra-
tion certificate, dated within the past 6 or 12 months. This meter is then placed on
a re-calibration schedule, as determined by local regulations. The re-calibration
date may be scheduled from the original calibration date, or simply placed on the
institution’s normal schedule interval for such meters.Re-calibration requires the
meter be shipped to a laboratory that is licensed to perform such a task. There is
no need to check the accuracy of the survey meter upon installation at the facility;
the facility generally has no means to check the accuracy of a survey meter.
The situation and requirement is different for Dose Calibrators. Although modern
manufacturing capabilities have improved the robust nature of dose calibrator
systems, these products tend to be more fragile than survey meters. Therefore,
the NRC determined at an early date that the dose calibrator accuracy must be
tested on site, prior to its introduction into clinical use. This was prudent since, a)
the dose calibrator was being used to measure radionuclides prior to administra-
tion to a patient and, b) the availability of sealed long lived isotopes made this
accuracy test very reasonable at a clinical facility.
The NRC now requires the facility using a dose calibrator to implement the
Manufacturer’s Instructions for Quality Assurance Testing of Dose Calibrators.
Such Instructions accompany all Atomlab Dose Calibrators, and requires the
Accuracy test "at installation and at least annually thereafter. After repair of the
dose calibrator, repeat the above tests as a new installation."
Therefore, the date on the Report of Calibration cannot be used as a substitute for
the installation accuracy test. The only significance of the date is when the dose
calibrator was calibrated at the manufacturer. It never receives another calibration
unless it is returned to the manufacturer. The accuracy test at the facility is not a
calibration; it is simply an accuracy test stating that the dose calibrator measures a
specific radionuclide within a stated error. The date on the Report of Calibration
does not expire until the dose calibrator is returned to the manufacturer.
ATOMLAB Dose Calibrator Operation Manual Chapter 1
Biodex Medical Systems J-5 Release 2.0
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