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Minnesota Administrative Rules

4732.1120 THERAPEUTIC EQUIPMENT PERFORMANCE TESTS AND LIMITS FOR MEASUREMENT EQUIPMENT.

Subpart 1.

Required tests.

A.

Installation calibration tests must be conducted prior to any patient use. Any adjustments must be made to bring the equipment up to a nationally recognized standard, such as Code of Federal Regulations, title 21, section 892, or manufacturer's specifications and to ensure compliance with this chapter prior to first use.

B.

Equipment performance tests must be conducted over all clinical ranges, when applicable. For equipment performance tests, any adjustments must be made to bring equipment to compliance with a nationally recognized standard, such as Code of Federal Regulations, title 21, section 892, or manufacturer's specifications and to ensure compliance with this chapter prior to using the equipment again.

Subp. 2.

Local standard (Loc. Std.) instrument.

TEST TYPE MINIMUM TEST INTERVAL TOLERANCE
A. AAPM - accredited dosimetry calibration laboratory calibration Intercomparison every 12 months
At intervals not to exceed 24 months traceable to NIST Standard
Documented and correction applied or noted in report of measurement when appropriate
B. Linearity At intervals not to exceed 48 months 0.5 percent
C. Venting At intervals not to exceed 48 months Documented and correction applied
D. Extracameral signal Initial use 0.5 percent
E. Leakage Each use 0.1 percent
F. Recombination Initial use Documented and correction applied
G. Collecting potential Each use Documented and correction applied

Subp. 3.

Other field instruments.

TEST TYPE MINIMUM TEST INTERVAL TOLERANCE
A. Local standard comparison At intervals not to exceed 24 months 1 percent
B. Linearity At intervals not to exceed 24 months Documented and correction applied
C. Venting At intervals not to exceed 24 months Documented and correction applied
D. Extracameral signal At intervals not to exceed 24 months Documented and correction applied
E. Leakage Each use 1 percent
F. Recombination Initial use Documented and correction applied
G. Collecting potential Each use Documented and correction applied

Subp. 4.

Relative dosimetry equipment.

TEST TYPE MINIMUM TEST INTERVAL TOLERANCE
A. Thermoluminescent Dosimeter
(1) Calibration Each batch or box Documented and correction applied
(2) Linearity Initial use Documented and correction applied
B. Film
(1) Dose and response Each batch or box Documented and correction applied
(2) Densitometer linearity At intervals not to exceed 12 months Documented and correction applied
C. Air ionization chamber system
(1) Linearity At intervals not to exceed 12 months Documented and correction applied
(2) Extracameral signal Initial use 1 percent
D. Diode system
(1) Energy dependence Initial use Documented and correction applied
(2) Extracameral signal Initial use Documented and correction applied
(3) Linearity Initial use Documented and correction applied

Subp. 5.

Radiation survey instruments.

TEST TYPE MINIMUM TEST INTERVAL TOLERANCE
A. Calibration At intervals not to exceed 12 months Documented and correction applied
B. Linearity At intervals not to exceed 12 months Documented and correction applied
C. Constancy Each use 5 percent

Subp. 6.

Positioning equipment lasers.

TEST TYPE MINIMUM TEST INTERVAL TOLERANCE
A. Accuracy Daily before patient use 2 mm
B. Hysteresis Each use 2 mm

Subp. 7.

Phantoms and attenuators.

TEST TYPE MINIMUM TEST INTERVAL TOLERANCE
A. Thickness Initial use Documented and correction applied
B. Density Initial use Documented and correction applied
C. Phantom stacked density Initial use Documented and correction applied
D. Detector fit Initial use Documented and correction applied

Subp. 8.

Accessory equipment.

TEST TYPE MINIMUM TEST INTERVAL TOLERANCE
A. Thermometer calibration Initial use 0.1 degree/C
B. Barometer (aneroid)
(1) Calibration Hg Initial use 1 mm Hg
(2) Intercomparison At intervals not to exceed 12 months 1 mm Hg

Statutory Authority:

MS s 144.12

History:

32 SR 777

Published Electronically:

December 10, 2007

700 State Office Building, 100 Rev. Dr. Martin Luther King Jr. Blvd., St. Paul, MN 55155 ♦ Phone: (651) 296-2868 ♦ TTY: 1-800-627-3529 ♦ Fax: (651) 296-0569