MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Compliance Verification
1
R302/A
- Compliance V
erification
Ralco
srl
COMPLIANCE VERIFICATION
M
INIMUM
F
ILTRATION
R
EQUIREMENT
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 Electromedical 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).
T
HE
F
OLLOWING
P
ROCEDURES
R
EQUIRE
T
HAT
X-
RADIATION
B
E
P
RODUCED
. T
AKE
A
DEQUATE
P
RECAUTIONS
T
HAT
N
O
P
ART
O
F
H
UMAN
B
EING
I
S
E
XPOSED
T
O
X-
RADIATION
, D
IRECT
O
R
I
NDIRECT
.
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
