The British Journal of Radiology, 72 (1999), 186^192 E 1999 The British Institute of Radiology

Report of an image quality and dose audit according to

Directive 97/43/Euratom at Spanish private
radiodiagnostics facilities
1
L GONZALEZ, PhD, 1E VANO, PhD, 2S OLIETE, MD, 3J MANRIQUE, MD,
4
J M HERNAEZ, MD, 4J LAHUERTA, MD and 4J RUIZ, MD
1
Medical Physics Group, Radiology Department, Complutense University, 28040 Madrid, 2Diagnostic
Radiology Service, Hospital Ruber Internacional, 28034 Madrid, 3 Diagnostic Radiology Service, Hospital
12 de Octubre, 28041 Madrid, and 4SANITAS, S.A. de Seguros, Medical Division, Serrano 88, 28006
Madrid, Spain

Abstract. An audit of Spanish private medicine radiodiagnostics facilities has been carried out,
based partly on Spanish legislation relating to European Directives on health protection against
ionizing radiation risks in medical exposure. The study included an appraisal of infrastructure
and equipment, and aspects of quality assurance and radiation protection, by means of data col-
lected through surveys. Of the 51 centres audited, a sample of 24 X-ray rooms was chosen, then an
external evaluation with regard to image quality and patient dose was performed, by an advisory
board of radiologists and medical physicists. The methodology used was similar to that of the group
of European Union experts in European dose evaluation and image quality trials. Chest, abdomen,
lumbar spine and breast examinations were monitored. Doses were measured with thermolumines-
cent dosimeters. A third of the X-ray rooms evaluated reached or exceeded dose reference values,
and in a third of the cases the image quality left considerable room for improvement. Breast and
chest examinations showed themselves to be the hardest to perform, not only as a result of exceed-
ing the reference doses, but also due to failure to meet good image quality standards.

The Council of the European Union (EU)
Directive 84/466/EURATOM [1], recently
replaced by 97/43/EURATOM [2], was implemen-
ted in Spanish legislation by Royal Decrees 1132/
1990 [3], 1891/1991 [4] and 2071/1995 [5]. The rst
of these, which lays down basic measures for pro-
tecting persons undergoing medical examinations
or treatment with radiation sources, is to be
applied to X-ray, radiotherapy and nuclear medi-
cine facilities, whereas the other two aect radio-
diagnostics only.
The last two Royal Decrees govern the installa-
tion and use of X-ray equipment for medical diag-
nostic purposes with regard to technical
specications in the design of an installation and
provision of radiation protection resources,
amongst other aspects. In addition, they lay down
quality criteria for verifying X-ray images, on a
compulsory annual basis, and their adaptation to
European quality standards, as the basis of a qual-
ity assurance plan for gradual implementation.
Under this legislation, the recommended image
quality and reference dose criteria are those of
document EUR 16260 [6] for chest, skull, lumbar
spine, pelvis and urinary tract examinations. For
Received 8 April 1998 and in revised form 18 September
1998, accepted 20 October 1998.
intraoral dental radiology the value of 7 mGy is
proposed, in line with the International Atomic
Energy Agency (IAEA) recommendations [7]. A
centre that performs examinations using other
than these projections may assess the quality of
its images by means of anatomical criteria devel-
oped for the purpose by its own eld radiologists,
and may set the rst average dose level found as the
``provisional reference value of the centre'' until
such time as it has representative reference values
for the examinations concerned. The dose evalua-
tions have to be based on 10 estimates for simple
examinations or on ve for complex examinations
(more than four images with possible use of uoro-
scopy). CT requires dose determination on the sur-
face of the patient, in the region scanned, or
related quantities (computed tomography dose
index (CTDI), multislice averaged dose (MSAD),
etc.), as well as recording the characteristic para-
meters (number of slices, thickness, etc.). The
image rejection rate should also be recorded. An
excess in the mean values of 25% over the reference
values requires investigation of the causes, with
correction of the protocols and/or suitable repair
or reconditioning of the equipment in a maximum
period of 2 months, followed by a subsequent
check on the ecacy of the changes that have taken
place.

186 The British Journal of Radiology, February 1999

Image and patient dose QC in Spanish private X-ray centres
Figure 1. Averaged values of entrance surface dose
obtained from the individual dose values of each centre
(represented by a bar), for chest and breast examina-
tions.
The application of this legislation in public hos-
pitals was immediate, although its actual imple-
mentation has been gradual. In private X-ray
facilities, however, the process has been slower
due to, among other reasons, a rather slow distri-
bution of information and awareness of the
requirements, and to possible economic implica-
tions as a result of expenses derived from changes
or repairs of faulty equipment. In addition, there is
still no surveillance mechanism to check the said
items by the Health Authority.
The above legislation has been used by a private
insurance company, ``SANITAS, S. A. de
Seguros'', to audit the infrastructure and general
quality of its aliated radiodiagnostics centres.
Furthermore, the company has carried out an
evaluation of patient dose and image quality in a
signicant sample of centres and X-ray rooms.
Taking into account the data available on private
radiology in Madrid [8], this action potentially
aects over 200 000 patients a year. This study
describes the experimental approach and the
results obtained.
Method
The audit was carried out in conjunction with
the Medical Physics Group of the Complutense
The British Journal of Radiology, February 1999
University of Madrid. An Advisory Committee,
comprising experienced radiodiagnostics specia-
lists, was formed to evaluate the image quality.
The audit was carried out in two stages.
(1) Evaluation of infrastructure and basic qual-
ity aspects of the services. The starting point was a
clinical audit survey model prepared by SANITAS
on infrastructure and equipment, which was sup-
plemented with quality assurance and radiation
protection aspects regulated in the legislation.
The survey consisted of two parts, one to be com-
pleted by an external auditor, who gathered the
immediately accessible information, and the other
to be sent by post and completed by the person in
charge of the centre, which enabled documents and
technical details to be obtained.
Both parts were used to create a database
on such aspects as accessibility to the centre for
handicapped patients, comfort, existence of ade-
quate technical means, percentage of examinations
supplied with the corresponding written reports,
renovation and maintenance of the equipment,
number of radiologists in relation to hours avail-
able for patient appointment, presence and train-
ing of sta and level of computerization of the
centre etc., as well as the degree of compliance with
guidelines laid down by the directors of the centre,
characteristic doses imparted in examinations,
when available etc. The survey covered 51 centres.
(2) From the centres which supplied complete
information and agreed to collaborate with the
programme (about 75% of the total), a selection
was made of 24 X-ray rooms from 12 centres, as a
sample for an external appraisal on image quality
and patient dose, supplementary to the one in the
previous paragraph. Thus, the bias that inevitably
appears as a result of either self-evaluation or dis-
crepancies attributable to dierent methods of
measuring were corrected. Rooms were selected
by the Advisory Committee taking into account
the type of examinations and workload to assure
samples of patients as required by the standard in
the examinations evaluated.
This stage was planned with a methodology similar
to that used by the group of experts of the European
Commission (EC) in its second European dose
evaluation and image quality trial [9], assessing chest
posteroanterior (PA), abdomen anteroposterior
(AP), lumbar spine AP and breast craniocaudal
(CC) projections. Doses were monitored with lithium
uoride (LiF) thermoluminescent dose meters
(TLDs), type TLD-100, from Harshaw TLD/
Bicron/NE-Technology (BICRON-NE, Solon, OH,
USA), individually calibrated, in a sample of ve
patients per room.The images obtained were initially
evaluated by the radiologists ofeach centre according
to the image quality criteria of document EUR 16260
[6]. Then, these images, their quality reports and the
dosemeters used were collected for evaluation by the
187

Table 1. Summary of ndings in relation to image quality and the radiation doses measured
Examination Total Image quality
number
of rooms Defective Fair Good
checked
Chest 5 1 2 1
Lumbar spine 8 1 4 3
Abdomen 3 1
Breast 8 1 3 2
Advisory Committee, and returned to the centre the
next day. The decision to monitor ve instead of 10
exposures, as in the case of European scale trials,
was taken to audit centres with a small workload,
thereby avoiding the need to store images for several
days. In this way, the usual process of providing the
images to the patients (immediate in private practice
in Spain) did not suer any signicant delay.
Furthermore, we were able to assure the availability
of images 24 h subsequentto their evaluation, bearing
in mind the limited capacity to analyse large numbers
of images by the board of experts.
Results
Evaluation of the survey questionnaires showed
that the facilities have a satisfactory level of equip-
ment and material resources. It was also important
to verify that all the sta taking the X-ray images
were duly accredited, with academic qualications
at medical or technical levels, plus accreditation on
radiation protection from the Nuclear Safety
Council (the Spanish regulatory body). At the pre-
sent time, no periodical retraining programmes are
followed, since this is not yet a compulsory
requirement.
The second stage evaluation enabled results to
be obtained with regard to the level of compliance
with image quality and patient dose guidelines.
Figure 1 shows examples of the average radiation
doses used to produce the images, for chest and
breast examinations. Figures 2a and b allow us to
compare the evaluations of the board of experts
with those of the eld radiologists regarding how
each image quality criterion is fullled in chest
and breast examinations.
The ndings with regard to the doses and quality
of the images are summarised in Table 1. The clas-
sication ``Defective'' refers to rooms which pro-
vided images regarded by the expert board as not
suitable for diagnosis; ``Fair'' is assigned to rooms
contributing images that permit diagnosis, even
though they fail to meet signicant quality criteria;
``Good'' refers to rooms with images which,
besides permitting diagnosis, meet the most rele-
vant quality criteria in all the images supplied,
and the classication ``Very good'' is reserved for
188
L Gonzalez, E Vano, S Oliete et al
Measured dose
Very good High Reference Low
1 2 2 1
2 3 3
2 3
2 3 1 4
rooms where every one of the images supplied
met practically all the criteria and the radiologists
on the panel of experts considered them of a very
good quality overall. Since the average dose values
are not based on 10 measurements, the dose classi-
cation ``High'' is conferred on X-ray rooms above
the reference value and in the band that is indica-
tive of anomalies, according to Spanish guidelines
(25% above European reference levels), ``Reference
value'' is applied to cases with that value or in a
band of 10% around it, and ``Low'' doses are those
clearly below the reference value.
Discussion
Since the results are obtained from a small num-
ber of measurements, the data should be
approached with caution. In addition, the partici-
pation of some centres with a small number of
patients (members of SANITAS), adds a further
degree of uncertainty, as some images come from
individuals whose weight and measurements do
not lie completely within the standard of the
EUR 16260 document [6]. Bearing in mind these
provisos, a third of the X-ray rooms investigated
produce images of a quality that is merely fair or
below the threshold of acceptability, while almost
a third generate them with doses that are clearly
above the reference value, according to Table 1.
Thus, both groups would benet considerably
from an optimization programme.
These ndings underline the urgent need to
implement a quality assurance programme. In
any case, since image quality can be appraised by
inspection and the centres may be assumed to have
made an eort to send their best images, the situa-
tion of the X-ray rooms with poor image quality is
qualitatively more acceptable, compared with
those that generate doses above the reference
value, as doses are not ``seen'' and discrepancies
from the reference value cannot be corrected. In
fact, the written evaluations made by the radiolo-
gists of each centre with their own images, in accor-
dance with the image quality criteria of the EUR
16260 document [6], show that, barring special
situations, the specialist identies some unsatisfac-
tory image details in his images, even in the cases in
The British Journal of Radiology, February 1999
Image and patient dose QC in Spanish private X-ray centres

(a) (b)

Figure 2. Graphs showing responses for each image quality criterion, according to the opinions of the eld radiolo-
gists and the board of experts, for (a) chest PA and (b) breast CC projections. The following image criteria are taken
from reference [6], although, for chest examinations, they are presented as in reference [9] for an easy comparison
with results of the 1991 EC trial. Chest: 1, performed at full inspiration and with suspended respiration; 2, symmetrical
reproduction of the thorax; 3, medial border of the scapulae to be outside of the lung elds; 4, reproduction of the
whole rib cage above the diaphragm; 5, visually sharp reproduction of the vascular pattern in the whole lung, particu-
larly the peripheral vessels; 6.a, visually sharp reproduction of the trachea and proximal bronchi; 6.b, visually sharp
reproduction of the borders of the heart; 6.c, visually sharp reproduction of the aorta; 7.a, visually sharp reproduction
of the diaphragm; 7.b, visually sharp reproduction of the lateral costophrenic angles; 8, visualization of the retrocar-
diac lung and the mediastinum. Breast: 1, visually sharp reproduction of pectoralis muscle at image margin; 2, visually
sharp reproduction of retroglandular fat tissue; 3, visually sharp reproduction of medial breast tissue; 4, visually
sharp reproduction of lateral glandular tissue; 5, no skinfolds seen; 6, symmetrical images of left and right breast;
7, visualization of skin outline with bright light; 8, reproduction of vascular structures seen through most dense par-
enchyma; 9, visually sharp reproduction of vessels and brous strands and pectoralis muscle margin (absence of
movement); 10, visually sharp reproduction of skin structure (rosettes from pores) along the pectoralis muscle.

which the overall image quality is considered
appropriate. In this way, this audit has fostered
the optimization of the images, with the result that
only three X-ray rooms have produced images that
are clearly decient. On the other hand, an anom-
aly in the image chain that may give rise to high
patient doses is not usually detected by the specia-
list.
The individual doses for the same study exhibit
variations of one order of magnitude, and even
more, depending on the equipment used, the
technique and other determining factors. Average
doses range by a factor of 2 (between 4 and 8 mGy)
in the abdomen, by factors of about 3 in the chest
and the breast (Figure 1) and between 2.2 and
17 mGy in the lumbar spine. For abdomen and
lumbar spine AP projections, the average dose
values obtained from the dierent centres are
below the reference dose value (10 mGy in both
examinations). This suggests that these reference
values are relatively high. On the other hand, for
chest and breast examinations the reference dose
values are often exceeded, even above the thresh-
old, indicating major anomalies according to
Spanish guidelines. In mammography we should
investigate the reasons. These include the need for
good radiographic technique and adequate com-
pression, which is not always successfully
achieved. In addition, the reference value in force
in Spain (7 mGy for a breast 4.5 cm thick, using
antiscatter grid), which is the one originally
adopted in the EC documents [10] (currently
updated as Report EUR-16260 [6]), is low in com-
parison with the values adopted for other examina-
tions. This is shown by the subsequent adoption by
the EC of a reference value of 10 mGy for breast
5 cm thick using an antiscatter grid. In the case of
chest examinations, it is not unusual to nd focal^
skin distances and operating voltages below the
values recommended in the EC guideline,

The British Journal of Radiology, February 1999 189


Table 2. Percentages of criteria not met and doubtful
per type of examination
Examination type % of criteria not met and doubtful
Committee of Field specialists
experts
Breast 34 15
Chest 18 11
Lumbar spine 16 7 sidered to be suitable in practice, in view of the fact
Abdomen 17 8 that they permit identication of the condition that
circumstances also observed in the instances of
high doses in lumbar spine examinations.
At centres where various rooms were audited,
practically any combination of image quality and
dose levels could be found. On many occasions
both parameters exhibited the same tendency that
could be expected from the rate of renewal of the
equipment (i.e. reasonably low doses and relatively
high image quality in modern equipment, and high
doses and comparatively inferior quality images in
cases where old equipment is used). However,
these problems are often due to ancillary equip-
ment, such as intensifying screens or cassettes.
This observation supports the supposition that
dramatic improvements can be achieved with mod-
est investments, or even at no cost at all [11^13], as
in cases of radiographic technique changes. No
correlation is found between image quality and
dose, as was already veried in the European study
[9], but the facilities that supplied decient quality
images produced dose averages above the reference
value.
The sensitivity of intensifying screen^lm sets is
not an item of information supplied systematically
by the centres, since this feature is probably not
known by the persons in charge. It may be inferred
from the information available, however, that
lm^screen combinations of nominal speed class
200 are still used in certain cases. Thus, the unsuit-
ability of the equipment, its age (especially the age-
ing of the intensifying screens), and details
concerning the techniques for obtaining the image
(especially tube potential, kVp) and inappropriate
geometric parameters (focal^skin distance, colli-
mation) among others, could result in the higher
dose values.
In quantitative terms, out of 24 facilities
audited, 10 would benet very substantially from
an immediate optimization programme, improv-
ing their image quality and/or reducing the doses.
The rest exhibit varying degrees of acceptability, so
the implementation of a quality assurance plan
would clearly improve the overall situation.
In the nal classication given to the images,
either as suitable or not suitable for diagnosis, it
190
L Gonzalez, E Vano, S Oliete et al
may be seen that the image quality criteria assume
healthy patients (as many details would not be seen
in certain types of disease) and standard anatomy
(e.g. certain symmetry or structure observation
requirements are not achieved in post-surgical
patients, those with deforming pathology, the
elderly or uncooperative subjects). Thus, images
that do not meet many quality criteria may be con-
was the reason for ordering the examination. In
such cases, the application of the quality criteria
of document EUR 16260 [6], which should reason-
ably be met in the image, has been a valuable help
and will, also in those cases, assist the optimization
process. In short, acceptance and transmission of
radiological images is not independent of the
patient's characteristics and there is a certain sub-
jectivity in the judgement. It is possible to identify
certain ``key'' criteria, however, for example in the
chest examination [14], the absence of which makes
the image unacceptable for diagnostic purposes in
most cases. This suggests the possibility of advan-
cing along the same lines for other types of exam-
ination.
Figure 2 allows us to see what criteria degrade
the radiographic image rst, and are at the same
time more dicult to meet without the aid of a
good technique in chest and breast examina-
tionsstudies in which the criteria are met with
apparent diculty. Table 2 groups the percentages
of image criteria that are not met or are doubtful
and helps to evaluate their restrictiveness or the
intrinsic diculty of an examination when it
comes to producing very high quality images.
Mammography is, by far, the examination that
requires most optimization. This is apparently
due to insucient compression in some cases,
and to a relatively common incomplete reproduc-
tion of the pectoralis muscle, even in images of
high quality with regard to almost all of the other
criteria. Correct patient positioning is therefore
shown to be one of the key criteria for producing
valid images for diagnosis. Reproduction of the
skin structure (pore rosettes) appears to be a criter-
ion that is better identiable in images obtained
with relatively modern equipment, and certain
intensifying screen^lm combinations. The radi-
ologists on the board of experts underlined the
importance of adequate training of the personnel
responsible for obtaining the mammograms and
even that it is preferable for them to be female to
facilitate the relationship with the patient and
improve the whole process. The PA chest examina-
tion continues to be a major challenge for the spe-
cialist, as frequent failures to comply with
signicant criteria are observed, even at specia-
lized centres. In lumbar spine examinations, cor-
rect X-ray beam collimation, sometimes not
The British Journal of Radiology, February 1999
Image and patient dose QC in Spanish private X-ray centres
performed, allows the reproduction of spinous and
transverse apophyses through enhancing the con-
trast, apart from the dose saving oered by this
practice. In a simple abdominal examination,
incorrect positioning often impedes reproduction
of the kidney area.
The data collected on the average radiological
voltage used in each type of examination and cen-
tre provides global mean tube potential values
below those recommended in the European docu-
ment EUR 16260 [6]. The causes should very prob-
ably be sought in the comparative improvement of
the contrast in the image through reducing the
tube potential, although the board of expert radi-
ologists and other specialists consulted suggest
that the voltage intervals applicable, reected as
an example of good ``technique'' in the lumbar
spine and abdomen examinations put forward an
upper limit that may prove excessive in specic
cases.
Lastly, we should mention that this study partly
anticipates the need for the clinical audit specied
in article 6.4 of Directive 97/43 EURATOM [2],
and is the rst action of this kind carried out in
Europe in the domain of private medicine,
according to the information available. Its preli-
minary results allow us to assure an improvement
in the quality of the whole medical process in
aspects of image quality and patient radiation
doses.
Conclusions
A QC check at 51 private radiology centres
has been carried out, sponsored for the rst
time in Spain by a private insurance company
and based on self-evaluation of the centres and an
external audit procedure taking the objective
form of experimental dose measurements
and evaluations of the quality of the radio-
graphic images. In the case of the 24 facilities eval-
uated externally, a third exceed the patient dose
reference levels recommended in the document
EUR 16260 [6] and a signicant improvement
in the quality of the radiological process, in
terms of dose and image quality, would be possible
in 10.
Barring exceptions, the image quality is consid-
ered acceptable for diagnosis, but the use of the
criteria of document EUR 16260 [6] leaves room
for improvement, even in cases where the image
quality is presumed to be appropriate. In this
sense, periodic retraining of sta should be
a requirement. On the other hand, the doses
for the same study exhibit large variations. For
both reasons, a systematic quality assurance
programme is advisable in all the centres,
including measurement of the patient dose and
evaluation of the image quality. In this way, the
The British Journal of Radiology, February 1999
``culture of quality'' would be gradually imple-
mented and the situation should become consi-
derably improved without a substantial cost
increase.
Of the examinations analysed, those referring to
breast and chest seem to be the most dicult to
perform not only because of the prospect of
exceeding the reference dose values, but also due
to failure to comply with the image quality criteria
proposed in document EUR 16260 [6]. On the basis
of higher statistics it may be seen that the low per-
centage of spine and abdomen images found in this
study with doses above the reference values sug-
gests that the values for these examination types
could be reduced. The upper threshold of tube
potential recommended in these examinations
could be too high in certain patients, impairing
the image quality due to lack of contrast.
Finally, although the quality criteria of the
images should normally be applied to healthy
patients, weighing around 70 kg according to the
recommendations of document EUR 16260 [6],
this is not always possible, especially at centres
where patients over a certain age or with certain
conditions are examined. However, the application
of the image quality criteria, based on knowledge
of the patient's characteristics, has assisted the
optimization process, despite the fact that the
images, although permitting a correct diagnosis,
do not meet all the image quality criteria in such
cases.
Acknowledgments
The authors thank Professor E Guibelalde and
J M Fernandez for their help in data processing,
and throughout the study.
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Catalogue of Diagnostic X-ray Spectra and Other
Data. IPEM Report No. 78 (CD-ROM), 1997
(IPEM, York), 20.00
ISBN 0904181 88X
Report SRS 30, detailing spectral data for diagnos-
tic X-rays, has been one of the most useful and
widely referenced reports produced by the HPA.
Report 78 from the IPEM, which updates and
extends these data, comes to us on CD-ROM. A
basic installation takes no time at all, requiring
only 5 MB of hard disk space. Once installed, you
have access to Report 78 itself, some software for
processing spectra and of course, lots of data. The
report gives a straightforward account of the var-
ious parameters aecting spectrum shape, com-
pares the new results against SRS 30 and
measured data and gives an example BASIC code
for manipulating the spectrum les.
The photon spectra themselves are saved as les
on the CD-ROM. Three target materials are con-
sidered: tungsten, molybdenum and rhodium. The
energy interval for each spectrum is 0.5 keV and
the constant potential spectra have been calculated
in 1 kV steps over the useful diagnostic energy
range. A range of target angles is also modelled,
at 1 intervals. Finally, the eect of waveform
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CS, Fernandez JM. Evaluation of the European
image quality criteria for chest examinations. Br J
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ripple (up to 30%) is modelled for tungsten target
spectra. Also held on the CD-ROM are half value
layer data and linear attenuation data for 32 com-
mon elements and compounds.
Although the Birch and Marshall algorithm was
used to calculate the spectra, some of the support-
ing data have changed. The XCOM attenuation
coecients are used instead of the well known
McMaster data. Furthermore, the SRS 30 compo-
sitions for air and tissue have been replaced by
ICRU-44 data for air and adipose tissue.
Perhaps the most useful part of the package is
the spectrum processor. This program lters a
spectrum with a combination of lter materials,
displays the result as a graph and saves the results
to le, if desired. Some users may nd the range of
lter materials a little limited and therefore a fea-
ture allowing the calculation of mass attenuation
coecients for user dened materials would be a
useful addition.
Overall, I think this is an extremely valuable
package with a wide range of applications, from
education through to use in routine work and
research. This CD-ROM oers excellent value for
money and is recommended without hesitation.
N MARSHALL
The British Journal of Radiology, February 1999