Ralco MTR 221/A - COMPLIANCE VERIFICATION; MINIMUM FILTRATION REQUIREMENT

MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
COMPLIANCE VERIFICATION
22
R221/A - R221/A DHHS - Compliance Verification
Ralco srl
COMPLIANCE VERIFICATION
MINIMUM FILTRATION REQUIREMENT
To indicate compliance with 21 CFR, sub-chapter J, part 1020 of Performance Standard it is
necessary for the assembler to perform a series of tests.
Description of test methods are illustrated in this chapter but factors, such as experience,
availability of equipment and tolerance on compliance are referred directly to the Safety
Standards covering Electro-medical equipment.
The above HVL requirements can be met if it is demonstrated that the aluminium equivalent in
the primary beam is not less than that shown in the following table:
The information contained in the above table was extracted from the Code of Federal
Regulations FDA 21 1020.30 (m).
Type 100 Aluminium Alloy (as given in “ALUMINUM STANDARDS AND DATA” verification of
compliance).
Visual Determination of Half-Value Layer (HVL)
The above HVL requirements can be met if it is demonstrated that the aluminium equivalent in
the primary beam is not less than that shown in the following Total Filtration table:
THE FOLLOWING PROCEDURES REQUIRE THAT X-RADIATION BE
P
RODUCED. TAKE ADEQUATE PRECAUTIONS THAT NO PART OF HUMAN
B
EING IS EXPOSED TO X-RADIATION, DIRECT OR INDIRECT.
Minimum Filtration Requirement - Beam Quality (HVL)
Designed
Operating Range
(kVp)
Measured
Operating
Potential (kVp)
Minimum HVL
(mm. Of Al) X-ray
System
Below 50
30
40
50
0.3
0.4
0.5
From 51 a70
51
60
70
1.2
1.3
1.5
Above 71
71
80
90
100
110
120
130
140
150
2.1
2.3
2.5
2.7
3.0
3.2
3.5
3.8
4.1