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Diagnostic Radiology and Pregnancy Position Statement PDF
Diagnostic Radiology and Pregnancy Position Statement PDF
Clinical Radiology
Position Statement
Approved by:
Council
Date of approval:
20 November 2017
New Zealand Office: Floor 6, 142 Lambton Quay, Wellington 6011, New Zealand
Email: ranzcr@ranzcr.edu.au
Website: www.ranzcr.edu.au
Telephone: +61 2 9268 9777
Facsimile: +61 2 9268 9799
Disclaimer: The information provided in this document is of a general nature only and is not intended as a
substitute for medical or legal advice. It is designed to support, not replace, the relationship that exists between a
patient and his/her doctor.
Document name Diagnostic Radiology and Pregnancy
Description This document discusses the effects of radiation on the fetus, and provides
some guidance to radiologists on the management of patients who are, or may
be, pregnant.
Created By Paediatric Imaging Reference Group
Date Created 2005
Maintained By Faculty of Clinical Radiology
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
Version Number Modifications Made Date Modified
1.0 Document published Nov 2005
2.0 Document updated Nov 2017
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TABLE OF CONTENTS
1. Introduction 5
2. Radiation Dose Specification1 5
3. The Effects of Ionising Radiation on the Fetus2,3,4,7 6
4. Doses from Diagnostic Radiological Procedures 7
5. The Pregnant Patient2,3 8
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
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About the College
The Royal Australian and New Zealand College of Radiologists (RANZCR) is a not-for-profit
association of members who deliver skills, knowledge, insight, time and commitments to promote the
science and practice of the medical specialties of clinical radiology (diagnostic and interventional) and
radiation oncology in Australia and New Zealand.
The Faculty of Clinical Radiology, RANZCR, is the peak bi-national body for setting, promoting and
continuously improving the standards of training and practice in diagnostic and interventional
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
radiology for the betterment of the people of Australia and New Zealand.
Our Vision
RANZCR as the peak group driving best practice in clinical radiology and radiation oncology for the
benefit of our patients.
Our Mission
To drive the appropriate, proper and safe use of radiological and radiation oncological medical
services for optimum health outcomes by leading, training and sustaining our professionals.
Our Values
Exemplified through an evidence-based culture, a focus on patient outcomes and equity of access to
high quality care; an attitude of compassion and empathy.
Exemplified through an ethical approach: doing what is right, not what is expedient; a forward thinking
and collaborative attitude and patient-centric focus.
Accountability
Code of Ethics
The Code defines the values and principles that underpin the best practice of clinical radiology and
radiation oncology and makes explicit the standards of ethical conduct the College expects of its
members.
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1. INTRODUCTION
(a) This Diagnostic Radiology and Pregnancy Position Statement is intended to assist The
Royal Australian and New Zealand College of Radiologists® (ABN 37 000 029 863) (the
College), its staff, Fellows, Members and other individuals with assessment and
communication of the potential fetal risks associated with exposure of pregnant women
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
to ionising radiation, in order to inform quality shared decision - making and risk - benefit
analysis regarding the use of medical imaging during pregnancy.
(b) This document discusses the theoretical effects of ionising radiation on the fetus, and
then provides some guidance to radiologists on the management of patients who are, or
may be pregnant; and who are intentionally or inadvertently exposed to ionising
radiation. The primary objective is to prevent unwarranted radiation exposure of the fetus
when medical diagnostic procedures are indicated during pregnancy, and to take
appropriate steps to assess and communicate risks in the event of intended or
inadvertent medical exposure of the pregnant woman.
1.2 Definitions
College means The Royal Australian and New Zealand College of Radiologists
NRPB means the National Radiological Protection Board, College of Radiographers, Royal
College of Radiologists
Gy is a unit of measurement of organ (or absorbed) dose and its units are Joules/kg of tissue
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3. THE EFFECTS OF IONISING RADIATION ON THE FETUS2,3,4,7
There are several phases of development during pregnancy. The terms conceptus or blastocyst
are commonly used during the initial phase from conception or fertilisation to implantation.
Implantation occurs during week 2 or 3 post conception. The term embryo is used during the
main period of organogenesis which occurs from weeks 3 to 8, and the term fetus thereafter. In
this document, for brevity, the term fetus is used to include all stages of development. Fetal
development is most accurately quantified as gestational age in weeks from the date of
conception. However, since the date of conception is often unknown, in clinical obstetric
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
practice, the duration of pregnancy is usually stated as the time from the date of the last
menstrual period (LMP). There is therefore typically a two-week difference between these two
methods of recoding fetal development. Sometimes fetal age is deduced from the size on
ultrasound.
The effects of radiation are related to the fetal effective dose and to the stage of pregnancy.
Post implantation, the main risks are induction of childhood cancer and leukaemia, as well as
neurological effects2,3.
Radiation doses of 100–500 mGy in the first few weeks after conception are associated with an
increased risk of fetal death. In animal studies high doses are associated with failure of
implantation.
3.3 Carcinogenesis
The epidemiological evidence for carcinogenesis comes mainly from studies of women who
underwent abdominal irradiation or pelvimetry during the 1950s4. The largest study was the
Oxford Survey of Childhood Cancers and that reported an increased rate of childhood cancer
and leukaemia5,6,7. In recent reviews, Doll and Wakeford5, and Wakeford and Little6 conclude
that doses of 10 mGy or higher to the fetus are likely to cause a small increase in the risk of
childhood cancer and leukaemia. They state that the magnitude of the effect from the radiation
is uncertain, but it is greater than zero and up to a possible maximum effect of 8% per Gy but
probably closer to 6% per Gy. The NRPB3 review of the data concludes that following fetal
doses of 10 mGy or greater, the excess risk is 6% per Gy; i.e., the excess risk per mGy up to
the age of 15 years, is estimated to be 1 in 17,000 for induction of cancer or leukaemia. The
NRPB also estimates that the excess risk per mGy for death from cancer or leukaemia is 1 in
33,0003. For comparison, in the UK the baseline risk of cancer or leukaemia in the first 15 years
of life is about 1 in 650 (0.15%)3.
The risk of cancer induction for a given fetal effective dose is considered to be uniform
throughout pregnancy after the first 3-4 weeks of gestation (5-6 weeks from LMP). There is
some controversy about the relative risk in the first 3-4 weeks of gestation.
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3.4 Genetic effects
The risk of heritable effects from fetal irradiation is very low, being much lower than the risk of
radiation induced carcinogenesis, and also very much lower than the natural risk of heritable
disease3. The natural frequency of heritable disease manifesting at birth is 1-3%, or 5-6% if
minor or uncertain congenital abnormalities are included3,5,7.
Preconception irradiation of either parent’s gonads has not been shown to result in increased
cancer or malformations in their children2.
Table 1 Fetal doses from common diagnostic procedures; taken from UK Survey of 19953.
Conventional x-ray
IVP 1.7 10
Pelvis 1.1 4
Computed tomography
Abdomen 8.0 49
Pelvis 25 79
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Note: These doses are a guide only and that individual doses will vary depending on the size of
the patient, position of the fetus and the age of gestation. Fetal doses cited are those assumed
from estimates of uterine doses, and refer to imaging in the first and second trimester.
In Australia a survey was done in 1997 of radiation doses from CT8. It showed that for CT of the
abdomen there was a wide distribution of doses to the uterus ranging from 1 mGy to 40 mGy
with a mean of 7.1 mGy. The authors state that a large component of the spread of doses has
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
come about because, depending upon technique, the uterus may have been fully, partially or
not at all covered by the scan.
While it is often assumed that irradiation of the pelvis will result in a uniform radiation dose to
the fetus, that is usually only true in early pregnancy. In the third trimester there may be
significantly different doses to different parts of the fetus.
If the specific radiation dose to the fetus needs to be determined, it is important to obtain an
estimate of the actual dose delivered, rather than use a published mean fetal dose for a
procedure. In this case a radiation medical physicist should be consulted.
The following sections provide guidance for the radiologist according to the status of
pregnancy2,3,6.
The radiologist responsible for the radiological examination should take all reasonable steps to
advise the medical team / referrer who is / are requesting the procedure and, if required, the
pregnant woman herself, of the potential risks of radiation exposure of the fetus.
Documentation in the medical record or the report of the imaging test that this discussion has
occurred and the risk estimates provided, should take place. Similarly, the referring doctor
should also advise the patient of the risks of radiation. This advice should be given before the
examination is performed unless there are compelling practical reasons, such as in an
emergency situation, when the advice has to be delayed until after the examination. In order to
advise the pregnant patient, the radiologist responsible for the procedure must be familiar with
the effects of ionising radiation on the fetus, be able to estimate the risks associated with the
particular examination and be able to communicate the risks to the patient in a meaningful
manner. The patient should receive information of these potential risks written in lay language
(see Appendix D for a sample), and be directed to the InsideRadiology consumer sites for
further information (www.insideradiology.com.au, www.insideradiology.co.nz).
For pregnant patients written informed consent is recommended if the pelvis is in the direct
beam.
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radiological procedures will exceed 100 mGy even if the uterus is in the direct beam. Most
diagnostic radiological procedures pose no substantial risk to the mother or fetus compared to
other risks throughout the pregnancy.
If it is decided that an x-ray procedure is necessary in a woman who is pregnant, and the uterus
is going to be in the direct beam, the technical factors for the procedure must be optimised to
minimise the radiation dose to the fetus. The technical details must be recorded to enable a
medical imaging physicist to estimate the dose received by the fetus.
If the fetal dose will be <1 mGy from the procedure, the examination can proceed normally.
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
This can only be assumed to be the case for x-ray examinations of areas of the body remote
from the lower abdomen3.
“If it is possible that you might be pregnant, notify the radiographer or other staff before you
have the x-ray examination.” Prior to an x-ray procedure being performed, all female patients of
child-bearing age must be questioned by the operator regarding the possibility of being
pregnant, and the patient’s response should be recorded.
As a means of avoiding unintentional irradiation of a fetus, in the early 1970s some authorities
recommended that women of childbearing age who were having routine radiological
procedures should have the x-rays done during the first two weeks of the menstrual cycle and
not in the latter part of the menstrual cycle. That recommendation became known as the “ten-
day rule”. By the 1980s it was recognised that that recommendation was unnecessary9.
It is now recommended that all patients be booked routinely. If there is concern about a
particular patient when they attend, a decision regarding the appropriate course of action is
made then, based on the recommendations below. The following recommendations depend
upon the radiation dose to the uterus from the planned procedure and upon an assessment of
the presence or absence of pregnancy3:
If there is no possibility of pregnancy, for instance the last menstrual period was within ten
days, proceed with the examination.
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7.3 Pregnancy possible and unable to be confidently excluded
This group includes patients where the menstrual period is overdue, those who are in the latter
part of the normal menstrual cycle, or who have irregular periods. The radiologist then needs to
assess the potential dose to the uterus from the procedure, which is mainly determined by
whether the uterus is in the primary beam. It is helpful to have knowledge of the magnitude of
doses from procedures in individual departments.
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
If the pelvis or abdomen is not in the direct beam the dose to the uterus is likely to be < 1 mGy.
Proceed normally with the examination provided it is justified in the usual way. For example,
plain radiography of the extremities, chest or skull gives doses of <1 mGy to the uterus (see
Table 1).
The risk of harm from this dose of radiation to a fetus is extremely low. In such cases it is
important to review the probability of pregnancy, the clinical indications for the test, and the
details of the procedure to be undertaken. Usually a decision is made to proceed with the test,
particularly if the only concern is that the patient is in the latter part of the menstrual cycle. The
radiologist should take particular care to ensure that the procedure uses the lowest radiation
dose that will provide the required diagnostic information. The technical details of the exposure
need to be recorded to enable doses to be calculated subsequently.
The most common radiological procedure that delivers high doses to the uterus is CT of the
pelvis. However, some fluoroscopic, barium and IVP contrast studies also can give doses of
this magnitude.
Where practicable, procedures that give doses of the order of >10 mGy to the uterus should be
avoided if there is a possibility of pregnancy and the pregnancy status is unknown or uncertain.
When a patient attends a radiology department to have a high uterine dose procedure, a
decision needs to be made by the radiologist about whether to defer the procedure until a time
when pregnancy can be confidently excluded, or to perform biochemical pregnancy testing with
serum HCG, or to proceed with the study. In such cases it is important to review the probability
of pregnancy, the clinical indications for the test, and the details of the procedure to be
undertaken. It should be remembered that delaying an essential diagnostic procedure until later
in pregnancy may present a greater risk to the fetus than performing the procedure during the
period of unknown pregnancy status2. The amount of discussion with the patient about the
effects of radiation depends upon the particular circumstances. The risks versus the benefits of
undertaking a procedure using high levels of ionizing radiation should involve managing clinical
team, the patient, and any caregiver(s)/guardian(s). If a decision is made to proceed, the
radiologist should take particular care to ensure that the procedure uses the lowest radiation
dose that will provide the required diagnostic information. The technical details of the exposure
need to be recorded to enable doses to be calculated subsequently.
8. RELATED DOCUMENTS
• RANZCR Code of Ethics
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9. ACKNOWLEDGEMENTS
This guideline was prepared in conjunction with the Paediatric Imaging Reference Group:
• Prof Michael Ditchfield (Chair)
• Dr Fiona Bettenay
• Dr Jonathon Corness
• Dr Rebecca Linke
• Dr Eleanoa Onikul
• Dr Mark Phillips
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
• Dr Peter Shipman
10. APPENDICES
A. Calman’s Risk Categories
B. Summary of Suspected In-Utero Induced Deterministic Radiation Effects
C. Summary of Key Differences Between Deterministic and Stochastic Radiation Effects
D. Radiation Exposure During Pregnancy and your Unborn Baby
11. REFERENCES
1. Recommendations for limiting exposure to ionizing radiation. ARPANSA Fundamentals
for Protection Against Ionising Radiation (RPSF-1), 2014 and Code for Radiation
Protection in Planned Exposure Situations (RPSC-1), 2016.
https://www.arpansa.gov.au/regulation-and-licensing/regulatory-publications/radiation-
protection-series
2. International Commission on Radiological Protection. Pregnancy and medical radiation,
Publication 84. Annals of the ICRP 30;1; 2000.
3. Sharp C, Shrimpton JA, Bury RF. Diagnostic Medical Exposures: Advice on Exposure to
Ionising Radiation during Pregnancy. National Radiological Protection Board, College of
Radiographers, Royal College of Radiologists; 1998.
4. Stewart A, Webb J, Giles D, Hewitt D. Malignant disease in childhood and diagnostic
irradiation in utero. Lancet. 1956 [cited 2017 Oct 19]; 2:447. Available from (purchase
required):
http://www.sciencedirect.com/science/article/pii/S0140673656919237?_rdoc=1&_fmt=hig
h&_origin=gateway&_docanchor=&md5=b8429449ccfc9c30159a5f9aeaa92ffb&ccp=y
5. Doll R, Wakeford R. Risk of childhood cancer from fetal irradiation. Br J Radiol. 1997
[cited 2017 Oct 19]; 70:130-139. Available from (purchase required):
http://www.birpublications.org/doi/10.1259/bjr.70.830.9135438
6. Wakeford R, Little MP. Risk coefficients for childhood cancer after intrauterine irradiation:
a review. Int J Radiat Biol. 2003 [cited 2017 Oct 19]; 79:293-309. Available from
(purchase required):
http://www.tandfonline.com/doi/abs/10.1080/0955300031000114729?needAccess=true&j
ournalCode=irab20
7. International Commission on Radiological Protection. Biological effects after prenatal
irradiation (embryo and fetus), Publication 90. Annals of the ICRP 33;1-2; 2003.
8. Thomson JEM, Tingey DRC. Radiation doses from computed tomography in Australia.
Australian Radiation Laboratory, Yallambie, Vic; 1997.
9. Radiation Health Committee of the 7th NHMRC. Modification of the ‘ten-day rule’.
Australasian Physical & Engineering Sciences in Medicine 1985; 8:7-8.
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APPENDIX A: CALMAN’S RISK CATEGORIES
(Ref: Cancer: science and society and the communication of risk”, BMJ 1996; 313: 799-802)
Descriptions of risk in relation to the risk of an individual dying (D) in any one year or
developing an adverse response (A)
Term
Risk range Example Risk estimate
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
used
High ≥ 1:100 (A) Transmission to susceptible 1:1-1
household contacts of measles and 2, 1:6
chickenpox1
(A) Transmission of HIV from mother to
child (Europe)2 1:10-1:20
(A) Gastrointestinal effects of antibiotics3
Low 1:1,000 - 1:10,000 (D) All kinds of violence and poisoning4 1:3,300
(D) Influenza5 1:5,000
(D) Accident on road4 1:8,000
References
1. Isselbacher KJ, Adams RD, Braunwald E, Petersdorf RG, Wilson JD, eds. Harrison's principles
of internal medicine. 9th ed. New York: McGraw Hill, 1975: 793.
2. Peckham C, Gibb D. Mother to child transmission of the human immunodeficiency virus. New
EngI J Med 1995; 333: 298-302.
3. Neu HC, Wilson APR, Gruneberg RN. Amoxycillin/clavulanic acid: a review of its efficacy in
over 38,500 patients from 1979 to 1992. J Chemotherapy 1993; 5:67-93.
4. The' BMA guide to living with risk. Harmondsworth: Penguin, 1990.
5. Immunisation against infectious disease. London: HMSO, 1992
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APPENDIX B: SUMMARY OF SUSPECTED IN-UTERO INDUCED
DETERMINISTIC RADIATION EFFECTS*1, 2
(Extracted from: Acr–Spr Practice Guideline for Imaging Pregnant or Potentially Pregnant
Adolescents and Women with Ionizing Radiation)
* Stochastic (statistical) risks are suspected, but data are not consistent3. For exposure to a
newborn child, the lifetime attributable risk of developing cancer is estimated to be 0.4% per 10
mGy dose to the baby. The potential risks in-utero for the second and third trimesters and part
of the first trimester may be comparable, but the uncertainties in this estimate are considerable.
References
1. International Commission on Radiological Protection. Pregnancy and Medical Radiation.
Bethesda, Md: ICRP Publication 84; 2000:1-43.
2. International Commission on Radiological Protection. Biological Effects after Prenatal
Irradiation (Embryo and Fetus). Bethesda, Md: ICRP Publication 90; 2003:1-200.
3. National Research Council. Health Risks from Exposure to Low Levels of Ionizing Radiation:
BEIR VII Phase 2. Washington DC: The National Academies Press; 2006.
Page 13 of 16
APPENDIX C: SUMMARY OF KEY DIFFERENCES BETWEEN DETERMINISTIC
AND STOCHASTIC RADIATION EFFECTS
Deterministic Stochastic
Diagnostic Radiology and Pregnancy Version 2.0 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
effect to occur exists, below which the effect
does not occur
Biological basis Result from cell death Result from cellular / DNA injury with
for effect preservation of cellular ability to
survive and divide
Effect on fetus / Fetal effects manifest as growth Effects occur in child and possibly
child / adult restriction, embryonic / fetal adult life manifest as increased risk of
death, malformations, adverse neoplasia
neurodevelopment – dose related
Relevant Do not occur with fetal exposures Increased risk of childhood cancer for
exposure range in the usual diagnostic range exposures < 1.5mGy (this includes all
and risk estimate (<100mGy) diagnostic studies using x – rays
without uterus in primary beam) ~
1:10,000. This includes chest CT.
Action for Expert medical physicist advice Expert medical physicist advice
radiologist in the required to calculate estimated required to calculate estimated uterine
event of uterine dose from a diagnostic dose, and thus theoretical risk of
deliberate or study of any type that includes the childhood carcinognesis, from a
inadvertent uterus in primary beam. A report diagnostic study of any type using x-
exposure at any should be prepared for the rays that includes the uterus in primary
time during radiology practice, patient and beam.
pregnancy referring doctor.
Page 14 of 16
APPENDIX D: RADIATION EXPOSURE DURING PREGNANCY AND YOUR
UNBORN BABY
Your doctor / medical team have referred you for ______________________________ procedure.
In discussion with your doctor(s) we think that the benefits to you of this test or procedure outweigh
any potential risks to your baby.
Radiation dose to your fetus can be measured and estimated. The measure we use is called milligray
(mGy). A CT scan of any part of the body other than your abdomen will typically expose your baby to
less than 2 mGy of ionising radiation.
The two types of risks to the unborn baby from ionising radiation exposure are:
These effects are seen only with doses of 100 mGy or more. These are very high doses that do
not occur with diagnostic radiology procedures and tests. Therefore, there is no risk of these
problems for your baby as a result of diagnostic x-rays or CT scans.
20 in every 10,000 (or 1 in 500) children who have had no ionising radiation exposure as an
unborn baby will be diagnosed with cancer sometime before the age of 18. This is the natural
rate of childhood cancers.
There is evidence that direct exposure of the unborn baby to medical x-rays can increase this risk but
only with direct exposure of your baby, for example with a CT scan or x-ray of your abdomen
or pelvis.
With most diagnostic radiological procedures, that do not involve direct exposure of your baby to the
x-ray beam (for example a chest x-ray, head or chest CT scan, mammogram, or an x-ray of your
neck, chest, arm or leg) your baby would receive less than 2 mGy of radiation exposure. The
theoretical risk of childhood cancer in this case would increase from 20 in every 10,000 to 21 in every
10,000. This is a very small increase.
With procedures that directly expose your baby to the x-ray beam during an abdominal CT, the dose
to your baby is likely to be around 20 - 50 mGy. However, this needs to be calculated by a specialist
medical radiation because the dose will vary depending on the kind of scan you are having (or have
had). This calculation will provide a more accurate estimate of exposure of your baby. This
information can be provided to you and your doctor by a specialist medical physicist.
With doses between 20 – 50 mGy, the theoretical risk of childhood cancer may be up to 40 in every
10,000 or 1 in 250.
You should feel free to discuss the following with your medical team if your test is not a medical
emergency:
• What alternatives tests are there, if any, that do not involve ionising radiation that could also
answer these questions
• What would happen if you do not have the test or if you wait until after your baby is born to
have it.
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References
1. Brent RL. Saving lives and changing family histories: appropriate counseling of pregnant
women and men and women of reproductive age, concerning the risk of diagnostic radiation
exposures during and before pregnancy. Am J Obstet Gynecol 2009;200 (1):4–24.
2. Wall BF, Meara JR, Muirhead CR, Bury RF, Murray M. Protection of pregnant patients during
diagnostic medical exposures to ionising radiation: advice from the Health Protection Agency,
the Royal College of Radiologists and the College of Radiographers. Documents of the Health
Protection Agency: Radiation, Chemical and Environmental Hazards. United Kingdom, 2009
Diagnostic Radiology and Pregnancy Version 2 | © The Royal Australian and New Zealand College of Radiologists® | November 2017
3. Tremblay E, Thérasse E, Thomassin-Naggara, I, and Trop I. Quality Initiatives: Guidelines for
Use of Medical Imaging during Pregnancy and Lactation. RadioGraphics 2012 32:3, 897-911
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