[CLASSIFICATION OF ITEMS OF NONCOMPLIANCE]{.underline}

[AND DEFECTS]{.underline}

[Class A]{.underline}

Conditions which may pose a serious radiation hazard to the public
health and safety.

l\. An x-ray system having a malfunction such that inadvertent exposures
could occur e.g., a system such that when the exposure switch is
activated, not one but repeated exposures occur, or the timer fails to
terminate exposure, or exposure initiated without utilizing the exposure
switch.

2\. A fluoroscopic x-ray system with an entrance exposure rate of
greater than or equal to 25 R/min. , except:

\(a\) During recording of fluoroscopic images, or

\(b\) When an optional high level control is activated. If the control
was manufactured after May 1995, the high level entrance exposure rate
is limited to 20 R/min and any reading exceeding 25 R/min is also a
Class A violation.

3\. A fluoroscopic system such that the entire x-ray beam is not
intercepted by the primary protective barrier.

4\. A fluoroscopic system such that x-ray production is possible when
the primary protective barrier is not in position to intercept the beam.

[Class B]{.underline}

[Certified Systems and Components Only]{.underline}

These are conditions that (1) would result in a large amount of
unnecessary radiation exposure during a routine diagnostic x-ray
examination, or (2) indicate other clearly defined items of
noncompliance (certified systems and components only). These conditions
may be determined in the field and calculated as in Reference 4 (the
Routine Compliance Test Manual). For purposes of regulatory follow up,
Class B conditions are divided into four groups according to the degree
of health hazard presented by the conditions. The groupings are:
Substantial Hazard, Moderate Hazard, Low Hazard, and Minimal Hazard (as
compared to a fully compliant x-ray system).

[Substantial Hazard]{.underline}

1\. An exposure rate beyond the plane of the image receptor, due to
transmission through the primary protective barrier of a fluoroscopic
x-ray system (with the attenuation block in the useful beam) of greater
than or equal to 10 mR/hr for each R/min of entrance exposure rate at 10
cm from any accessible surface of the fluoroscopic imaging assembly.

2\. An image‑intensified fluoroscopic x-ray system such that the total
misalignment of the edges of the x-ray field with the respective edges
of the visible area of the visually defined field in the plane of the
image receptor is greater than 10 percent of the SID.

3\. A spot film device such that the total misalignment of the x-ray
field with the respective edges of the selected portion of the image
receptor along the length or width dimensions of the x-ray field in the
plane of the image receptor, when adjusted for full coverage of the
selected portion of the image receptor, exceeds 10 percent of the SID.

4\. A radiographic x-ray system having positive beam limitation where
the x-ray field size in the plane of the image receptor, whether
automatically or manually adjusted, is such that either the length or
the width of the x-ray field differs from that of the image receptor by
greater than 10 percent of the SID when the equipment indicates that the
beam axis is perpendicular to the plane of the image receptor.

5\. Mobile radiographic systems where the illuminance of the light
localizer is less than 96 lux at a 100 centimeter measurement distance.

[Moderate Hazard]{.underline}

l\. For radiographic x-ray systems:

a\. A radiographic x-ray system having positive beam limitation where
the x-ray field size in the plane of the image receptor, whether
automatically or manually adjusted, is such that either the length or
the width of the x-ray field differs from that of the image receptor by
greater than 5% of the SID and that the sum of the length and width
differences without regard to sign be greater than 7% of the SID when
the equipment indicates that the beam axis is perpendicular to the plane
of the image receptor.

b\. A radiographic x-ray system providing means to align the center of
the x-ray field with respect to the center of the image receptor and the
misalignment is greater than or equal to 5 percent of the SID.

c\. A radiographic x-ray system providing means for visually defining
the perimeter of the x-ray field and the total misalignment of the edges
of the visually defined field is greater than 5 percent of the distance
from the source to the center of the visually defined field when the
surface upon which it appears is indicated to be perpendicular to the
axis of the x-ray beam.

d\. A coefficient of variation greater than or equal to 0.10 for a
sample set of ten exposures as described in Reference 4.

e\. A half‑value layer more than 1/2 mm aluminum below the appropriate
value listed in 21 CFR 1020.30 Table I.

f\. Systems equipped with positive beam limitation where at SIDs for
which the device is designed to operate, it does not either cause
automatic adjustment of the x-ray field to the image receptor size in
the plane of the image receptor within 5 seconds after insertion of the
image receptor; or if adjustment is accomplished automatically in a time
interval greater than 5 seconds, or manually, does not prevent the
production of x-rays until such adjustment is made.

g\. An average light localizer illuminance of less than 96 lux for
stationary systems and between 96 and 144 lux for mobile systems, as
measured with a Digiphot at a measurement distance of 100 centimeters or
the maximum SID, whichever is greater.

h\. A capacitor storage system such that the standby radiation is
greater than or equal to 25 mR/hr.

i\. A measured kilovoltage greater or less than the manufacturer\'s
upper or lower accuracy limits:

\(1\) [Measured kilovoltage greater than the indicated
kilovoltage]{.underline} A measured kilovoltage more than 105 percent of
the manufacturer\'s upper accuracy limit for indicated kilovoltage.

\(2\) [Measured kilovoltage less than the indicated
kilovoltage]{.underline} A measured kilovoltage that is less than 95
percent of the manufacturer\'s lower limit for indicated kilovoltage.

j\. Intraoral dental systems capable of operation in the above 50 kVp
range which exhibit a minimum source to skin distance less than 16
centimeters.

k\. Intraoral dental systems capable of operation in the above 50 kVp
range for which the field size at the cone tip is greater than or equal
to 9 centimeters.

l\. Dental radiographic systems in which it is possible to produce
x-rays with the timer in the zero or off position.

m\. Mammographic x-ray systems in which the edge of the x-ray field at
the chest wall extends beyond the edges of the image receptor by more
than 5 percent of the source to image receptor distance.

2\. For fluoroscopic x-ray systems:

a\. An image‑intensified fluoroscopic x-ray system such that the total
misalignment of the edges of the x-ray field with the respective edges
of the visually defined field in the plane of the image receptor is
equal to or greater than 6 percent, but less than 10 percent of the SID,
and the sum, without regard to sign, of the misalignment along any two
orthogonal dimensions intersecting at the center of the visible area of
the image receptor is equal to or greater than 8 percent of the SID.

b\. A nonimage‑intensified fluoroscopic system such that any dimension
of the x-ray field extends beyond the visible portion of the image
receptor by greater than 8 percent of the SID.

c\. For conditions described in 21 CFR 1020.32(d), if the maximum
allowable entrance exposure rate is 5 R/min., test values of greater
than or equal to 5.6 R/min., but less than 25 R/min. Correspondingly,
for a maximum allowable rate of 10 R/min., test values of greater than
or equal to 11.5 R/min. but less than 25 R/min. are included.

d\. Half‑value layer values which are more than 1/2 mm below the value
specified in 21 CFR 1020.30 Table I.

e\. An exposure rate due to transmission through the primary protective
barrier of a fluoroscopic system with the attenuation block in the
useful beam of greater than or equal to 4 mR/hr but less than 10 mR/hr
for each R/min of entrance exposure rate at 10 cm beyond the plane of
the image receptor.

f\. A spot film device such that the total misalignment of the x-ray
field with the respective edges of the selected portion of the image
receptor along the length or width dimensions of the x-ray field in the
plane of the image receptor, when adjusted for full coverage of the
selected portion of the image receptor, exceeds 6 percent, but is less
than 10 percent of the SID. The sum without regard to sign of the
misalingment along any two orthogonal dimensions exceeds 7 percent of
the SID.

g.  Stationary fluoroscopes with a minimum source‑to‑skin distance of
    less than 35.2 centimeters.

h.  Mobile fluoroscopes with a minimum source-to-skin distance of less
    than 27.2 centimeters or 18.1 centimeters when configured for
    surgical use (e.g. spacer removed).

i.  For controls manufactured after May 1995, which have high level
    controls limited to 20 R/min, test values of greater than 21.5 R/min
    but less than 25 R/min.

j.  Other similar situations.

    [Low Hazard]{.underline}

1\. For radiographic x-ray systems:

a\. A coefficient of variation greater than or equal to 0.084 for a
sample set of four exposures, or between 0.06 and 0.10 for a sample set
of ten exposures as described in Reference 4.

b\. A linearity value of greater than or equal to 0.153. This value is
based upon two sample sets of at least four exposures each, as described
in Reference 4.

c\. A radiographic x-ray system having indicated field size dimensions
such that aperture adjustments result in x-ray field dimensions that
differ from those of the image receptor by equal to or greater than 5
percent of the SID when the beam axis is intended to be perpendicular to
the plane of the image receptor.

d\. A stationary general purpose radiographic x-ray system (i.e., one
equipped with stepless adjustment of the size of the x-ray field) such
that the actual SID differs from the indicated SID by more than 5
percent of the indicated SID. These values are based on a test procedure
using a direct measurement of the distance from the focal spot to the
tabletop and from the tabletop to the film plane as described in
Reference 4.

e\. For stationary systems only, an average light localizer illuminance
of between 96 and 144 lux as measured with a Digiphot.

f\. A capacitor storage radiographic system such that the standby
radiation is greater than 3.0 mR/hr, but less than 25 mR/hr.

g\. Systems equipped with positive beam limitation devices which do not
allow the field size to be reduced to a size less than that of the image
receptor.

h.  Systems equipped with positive beam limiting devices which do not
    provide for an automatic return to PBL from a reduced field size.

i.  Mobile radiographic systems for which the minimum source to skin
    distance is less than 27.5 centimeters.

\* j. Mammographic systems for which the edges of the x-ray field on any
side extend beyond the edge of the image receptor by more than 5 percent
of the SID. \*

k\. (1) When the maximum operating range is above 70 kVp; A half‑value
layer (HVL) between (0.15 + 0.04 x HVL) mm and 0.5 mm aluminum below the
appropriate value listed in 21 CFR 1020.30 Table I.

\(2\) When the maximum operating range is 50 to 70 kVp: A half‑value
layer (HVL) between (0.08 + 0.04 x HVL) mm and 0.5 mm aluminum below the
appropriate value listed in 21 CFR 1020.30 Table I.

\(3\) When the maximum operating range is less than 50 kVp: A half‑value
layer (HVL) between 0.1 mm and 0.5 mm aluminum below the appropriate
value listed in 21 CFR 1020.30 Table I.

l\. Systems equipped with positive beam limitation, which do not prevent
the production of x-rays at SID\'s greater than 36 inches where the PBL
device is not intended to operate.

2\. For fluoroscopic x-ray systems:

a\. Fluoroscopic systems equipped with high level control which do not
provide an audible indication of the activation of the high level
control.

b\. Half‑value layer (see item k(1) under radiographic systems).

\* c. Systems which do not provide either continuous audible signal or
termination of x-rays at the completion of a previously selected time
interval. \*

[Class B]{.underline}

[Uncertified Systems and Components Only]{.underline}

Other situations similar to those of Class B certified systems and
components which in the judgement of the auditor constitute a defect as
defined in 21 CFR 1003.2(b).

[Class C]{.underline}

[Certified Systems and Components Only]{.underline}

These are conditions that indicate test results exceeding the
requirements of the standard but less than the values for Class B
noncompliances for certified systems and components only. These may be
determined in the field and calculated as in Reference 4.

l\. For radiographic x-ray systems:

a\. A radiographic x-ray system having positive beam limitation where
the x-ray field size in the plane of the image receptor, whether
automatically or manually adjusted, is such that either the length or
the width of the x-ray field differs from that of the image receptor by
3.00 to 4.99 percent of the SID and that the sum of the length and width
differences without regard to sign be between 4.00 and 6.99 percent of
the SID when the equipment indicates that the beam axis is perpendicular
to the plane of the image receptor.

b\. A radiographic x-ray system providing means to align the center of
the x-ray field with respect to the center of the image receptor and
misalignment is between 2.00 and 4.99 percent of the SID.

c\. A radiographic x-ray system providing means for visually defining
the perimeter of the x-ray field and the total misalignment of the edges
of the visually defined field is between 2.00 and 4.99 percent of the
distance from the source to the center of the visually defined field
when the surface upon which it appears is indicated to be perpendicular
to the axis of the x-ray beam.

d\. A radiographic x-ray system having indicated field size dimensions
such that aperture adjustments result in x-ray field dimensions that
differ from those of the image receptor by between 2.00 and 4.99 percent
of the SID when the beam axis is indicated to be perpendicular to the
plane of the image receptor.

e\. A stationary radiographic x-ray system providing means for stepless
adjustment of the size of the x-ray field such that the actual SID is
either larger or smaller than the indicated SID by between 2.00 and 4.99
percent. These values are based on a test procedure using direct
measurement of the distance from the focal spot to the tabletop and from
the tabletop to the film plane as described in Reference 4.

f\. A coefficient of variation greater than 0.050 but less than 0.084.
This value is based upon a sample set of four exposures. When a set of
ten exposure values is made, the upper limit is reduced from 0.084 to
0.06 (see Reference 4).

g\. Linearity value of greater than 0.100 but less than 0.152. This
value is based upon two sample sets of at least four exposures each, as
described in Reference 4.

h\. (l) When the maximum operating range is above 70 kVp: A half‑value
layer (HVL) below the appropriate value listed in 21 CFR 1020.30 Table I
but less than (0.15 + 0.04 X HVL) mm Al below the listed value.

\(2\) When the maximum operating range is 50 to 70 kVp: A half‑value
layer below the appropriate value listed in 21 CFR 1020.30 Table I but
less than (0.08 + 0.04 X HVL) below the listed values.

\(3\) When the maximum operating range is less than 50 kVp: A half‑value
layer (HVL) below the appropriate value listed in 21 CFR l020.30 Table I
but less than 0.1 mm Al below the listed value.

i\. An average light localizer illumination greater than 144 but less
than 160 lux as measured with a Digiphot.

j\. A capacitor energy storage radiographic system such that the standby
radiation is greater than 2.0 mR/hr but less than 3.0 mR/hr.

k\. A measureable kilovoltage greater or less than manufacturer\'s upper
or lower accuracy limits.

\(l\) [Measured kilovoltage greater than indicated
kilovoltage]{.underline} A measured kilovoltage ranging from the
manufacturer\'s upper accuracy limit to a measured kilovoltage such that
95 percent of this value is greater than the upper accuracy limit.

[Example]{.underline}: The indicated kilovoltage on the x-ray control is
100 kVp. If the manufacturer states an accuracy of [+]{.underline} 10
percent, the upper and lower accuracy limits would be 110 kVp and 90
kVp, respectively. In this case, a measured kilovoltage ranging from 110
kVp to 115.8 kVp would be a Class C noncompliance.

\(2\) [Measured kilovoltage less than indicated kilovoltage]{.underline}
A measured kilovoltage ranging from the manufacturer\'s lower accuracy
limit to a measured kilovoltage such that 105 percent of this value is
less than the lower accuracy limit.

[Example]{.underline}: The indicated kilovoltage on the x-ray control is
100 kVp. If the manufacturer states an accuracy of [+]{.underline} 10
percent, the upper and lower accuracy limits would be 110 kVp and 90
kVp, respectively. In this case, a measured kilovoltage ranging from 90
kVp to 85.7 kVp would be a Class C noncompliance.

2\. For fluoroscopic x-ray systems:

a\. An image‑intensified fluoroscopic x-ray system such that the total
misalignment of the edges of the x-ray field with the respective edges
of the visible area of the visually defined field in the plane of the
image receptor is greater than 3 percent but less than 6 percent of the
SID, and the sum, without regard to sign, of the misalignment along any
two orthogonal dimensions intersecting at the center of the visible area
of the image receptor is greater than 4 percent but less than 8 percent
of the SID.

b\. A nonimage‑intensified fluoroscopic system such that any dimension
of the x-ray field extends beyond the visible portion of the image
receptor but by less than 8 percent of the SID.

\* c. For conditions described in 21 CFR l020.32(d), if the maximum
allowable entrance exposure rate is 5 R/min., test values of greater
than 5.0 R/min., but less than 5.6 R/min. Correspondingly, if the
maximum allowable entrance exposure rate is 10 R/min., test values of
greater than 10.0 R/min. but less than 11.5 R/min. are included. \*

d\. Half‑value layer (see h(1) under radiographic x-ray systems this
section).

e\. An exposure rate due to transmission through the primary protective
barrier of a fluoroscopic system with the attenuation block in the
useful beam of greater than 2.0 mR/hr but less than 4.0 mR/hr for each
R/min. of entrance exposure rate at 10 cm beyond the plane of the image
receptor.

f\. A spot film device such that total misalignment of the x-ray field
with the respective edges of the selected portion of the image receptor
along the length or width dimensions of the x-ray field in the plane of
the image receptor, when adjusted for full coverage of the selected
portion of the image receptor, is greater than 3 percent but less than 6
percent of the SID. The sum without regard to sign of the misalignment
along any two orthogonal dimensions is greater than 4 percent but less
than 7 percent of the SID.

g.  For controls manufactured after May 1995 which contain high level
    controls, where the maximum allowable entrance exposure rate is 20
    R/min, test values greater than 20 R/min, but less than 21.5 R/min.

h.  Stationary fluoroscopes with a minimum source‑to‑skin distance
    between 35.2 centimeters and 38 centimeters.

i.  Mobile fluoroscopes with a minimum source-to-skin distance between
    27.2 centimeters and 30 centimeters or between 18.1 centimeters and
    20 centimeters when configured for surgical use (e.g. spacer
    removed).

j.  

k.  Other similar situations.

    [Class C]{.underline}

    [Uncertified Systems and Components Only]{.underline}

Other situations similar to those of Class B certified systems and
components which in the judgment of the auditor meet the definition of
21 CFR 1003.2(b).

[Class D]{.underline}

All items which indicate a system in compliance.

[\*]{.underline}

[Class E]{.underline}

These items are minor functional noncompliances which may not be
assembler related. They do not warrant a Notification letter by
themselves, but may be included in a Notification letter issued because
of other violations (similar to notification of Class C violations).

[Minimal Hazard]{.underline}

1\. For radiographic systems:

a\. Stationary systems where there are no means to indicate when the
beam axis is perpendicular to the plane of the image receptor.

b\. Stationary systems where means are not provided to center the
diagnostic source assembly over the image receptor.

c\. Systems where technique factors are not indicated at the operator\'s
position.

d\. Systems which lack a warning label.

2\. For fluoroscopic systems:

a\. No warning label present on the master x-ray control panel.

b\. Systems where the tube potential and tube current are not
continuously indicated during x-ray exposure.

\*