ISO 12749-6:2020

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 12749-6
ISO/TC 85
Nuclear energy, nuclear technologies,
Secretariat: AFNOR
and radiological protection —
Voting begins on:
2020-09-02 Vocabulary —
Voting terminates on:
Part 6:
2020-10-28
Nuclear medicine
Énergie nucléaire, technologies nucléaires et protection
radiologique — Vocabulaire —
Partie 6: Médicine nucléaire
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Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 12749-6:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
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©
NATIONAL REGULATIONS. ISO 2020

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ISO/FDIS 12749-6:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ISO/FDIS 12749-6:2020(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Basic terms related to nuclear medicine . 1
3.2 Terms related to diagnostic nuclear medicine . 2
3.3 Terms related to therapeutic nuclear medicine . 3
3.4 Terms related to radiopharmacy . 4
3.5 Terms related to medical equipment . 5
3.6 Terms related to medical studies . 6
Annex A (informative) Methodology used in the development of the vocabulary .9
Bibliography .17
Alphabetical index .18
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ISO/FDIS 12749-6:2020(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies,
and radiological protection.
A list of all parts in the ISO 12749 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO/FDIS 12749-6:2020(E)

Introduction
This document provides terms and definitions for nuclear medicine, the medical discipline whereby
radioisotopes as unsealed sources are administered to patients, in order to carry out diagnostic exams,
therapeutic treatments for various pathologies and to monitor the evolution of the disease.
This multidisciplinary activity is fundamentally made up of medical, radiopharmaceutical and medical
physics components, although it also relies on nuclear science, biology, biochemistry, radiochemistry,
nuclear chemistry, electronics, electro-mechanics, computing, metrology of ionizing radiation and
dosimetry. It involves tasks relating to support, research and development as well as staff training,
which are all carried out intensively in this field.
The specific areas of most relevance to nuclear medicine are oncology, cardiology, endocrinology and
neurology. However, its reaches practically every medical specialty.
The professional and technical staff who work in nuclear medicine are highly specialized, carrying out
their activities in highly complex facilities, using a large range of equipment, within a strict healthcare
and radiological regulatory setting.
These activities produce a large amount of documentation such as reports, publications, legal
documents and teaching texts, all of which require the use of precise, coherent and unambiguous terms
and definitions. Therefore, it becomes essential to harmonize the terminology used by all of the above-
mentioned sectors and professions.
Conceptual arrangement of terms and definitions is based on concepts systems that show corresponding
relationships among nuclear medicine concepts. Such arrangement provides users with a structured
view of the nuclear medicine sector and will facilitate common understanding of all related concepts,
see also Annex A. Besides, concept systems and conceptual arrangement of terminological data will be
helpful to any kind of user because it will promote clear, accurate and useful communication.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 12749-6:2020(E)
Nuclear energy, nuclear technologies, and radiological
protection — Vocabulary —
Part 6:
Nuclear medicine
1 Scope
This document contains the terms, definitions, notes to entry and examples corresponding to the
frequently used concepts which apply to diagnostic and therapeutic nuclear medicine.
It comprises the minimum essential information for each nuclear medicine concept represented by a
single term. It provides the reader with the information required to approach this multidisciplinary
speciality, such as medical, radiopharmacy and medical physics point of view. It is intended to facilitate
communication and promote common understanding.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1 Basic terms related to nuclear medicine
3.1.1
nuclear medicine
field of medicine in which unsealed radioactive sources, namely radiopharmaceuticals (3.4.3), are used
for diagnosis or therapy
3.1.1.1
diagnostic nuclear medicine
scientific and clinical discipline in which radiopharmaceuticals, administered by different routes, are
used for diagnostic purposes
Note 1 to entry: Diagnostic nuclear medicine is mainly carried out through imaging but may also be measurements
of the global or regional function of an organ.
Note 2 to entry: Diagnostic nuclear medicine also includes quantitative imaging and patient monitoring for the
follow-up of both the disease progression and the treatment response.
3.1.1.2
therapeutic nuclear medicine
scientific and clinical discipline in which radiopharmaceuticals are administered for therapeutic
purposes
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3.1.2
theragnostics
theranostics
treatment strategy based on personalized medicine, that allows selecting the most appropriate therapy
according to the diagnostic images
Note 1 to entry: In nuclear medicine, the specific targeted diagnostic test and therapy can be made sequentially
with the same radiolabelled molecule (i.e. radiopharmaceutical) or with the same molecule and different label
radionuclides or with different molecules with similar physiological properties.
EXAMPLE Personalized treatment of a patient with a positive somatostatin receptor image (neuroendocrine
tumor) by a radiopharmaceutical composed of somatostatin analogs peptide labelled with an emitter suitable for
molecular radiotherapy.
3.1.3
radiopharmacy
branch of pharmacy, which deals with the preparation, characterization and quality of radioactive
drugs in nuclear medicine procedures
EXAMPLE The final stage or the preparation of the pharmaceutical and/or activity dispensing is carried out
from commercial products in a hospital radiopharmacy or in centralized radiopharmacies and then delivered to
a hospital radiopharmacy.
3.1.4
administered activity
activity (in Bq) of radiopharmaceutical that has been dispensed to the patient for diagnostic or
therapeutic purposes
Note 1 to entry: The activity of radiopharmaceuticals is measured in megabecquerels.
3.1.5
uptake
accumulation of administered activity to a particular organ or tissue at a particular time after
administration
[SOURCE: NATIONAL COUNCIL ON RADIATION PROTECTION AND MEASUREMENTS. NCRP Composite
Glossary. NCRP, Bethesda, 2011]
3.2 Terms related to diagnostic nuclear medicine
3.2.1
diagnostic nuclear medicine
(See 3.1.1.1)
3.2.2
nuclear medicine imaging
imaging performed after administration of a radiopharmaceutical
Note 1 to entry: Imaging is considered a non-invasive diagnostic technique, as opposed to a biopsy or exploratory
surgery.
Note 2 to entry: PET and SPECT are the main type of nuclear medicine imaging providing information about how
certain tissues and organs are functioning. It is complementary to anatomical imaging, such as X-ray imaging.
3.2.3
molecular imaging
MI
imaging allowing the visualization, characterization, and measurement of biological processes at the
molecular and cellular levels in humans and other living systems
Note 1 to entry: Nuclear medicine imaging (3.2.2) is one of the modalities of molecular imaging.
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[SOURCE: Mankoff DA. A definition of molecular imaging. J. Nucl. Med. 2007 Jun;48(6):18N, 21N,
modified.]
3.2.4
quantitative imaging
extraction and use of numerical/statistical features from medical images
Note 1 to entry: The chief method used in quantitative imaging is to delineate a region of interest on the image
and determine the mean uptake in this region, but many other features can be extracted.
[SOURCE: Abramson RG, Burton KR, Yu JP, et al. Methods and challenges in quantitative imaging
biomarker development. Academic Radiology 2015 Jan, 22(1):25-32].
3.2.5
diagnostic reference level
DRL
level used in medical imaging to indicate whether, in routine conditions, the activity of a
radiopharmaceutical administered in a specified radiological procedure is unusually high or unusually
low for that procedure
Note 1 to entry: In diagnostic nuclear medicine, DRL is a level of activity for typical examinations for groups of
standardized patients.
[SOURCE: IAEA SAFETY STANDARDS SERIES No. GSR Part 3 (2014), modified.]
3.2.6
standard uptake value
SUV
value equal to the radio of the image derived r adioactivity concentration (in kBq/ml) to the whole
body concentration (in kBq/kg)
Note 1 to entry: Mainly used in PET imaging, but also in SPECT imaging.
Note 2 to entry: There are other definitions of the SUV when substituting the body weight with the lean body
weight or the body surface area. In addition, from a region of interest, several SUV values can be extracted (such
as the maximum, the mean SUV-value, etc.).
3.3 Terms related to therapeutic nuclear medicine
3.3.1
therapeutic nuclear medicine
(See 3.1.1.2)
3.3.2
radiotherapy
radiation therapy
therapy that uses ionizing radiation to kill cells and shrink pathological tissues
Note 1 to entry: Radiation may be delivered by a machine outside the body (external-beam radiation therapy),
or it may come from radioactive material placed in the body near cancer cells (brachytherapy) or from
radiopharmaceutical administered to the patient (molecular radiotherapy).
3.3.3
molecular radiotherapy
radiation therapy that uses a radiopharmaceutical to kill pathological cells and tissues by the effect of
ionizing radiation
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3.3.3.1
metabolic radiotherapy
molecular radiotherapy using selective irradiation of a target zone by a radiopharmaceutical
participating in the metabolism of tumor cells administered to the patient
EXAMPLE The most widely used form of molecular radiotherapy is for the treatment of thyroid pathologies
(thyroid cancer and hyperthyroidism). Called radioiodine therapy, this treatment consists of an oral
administration of iodine-131, which will primarily concentrate in the thyroid to kill diseased cells.
3.3.3.2
radioimmunotherapy
RIT
molecular radiotherapy based on a personalized cancer treatment that combines radiation therapy
with the precise targeting ability of immunotherapy, a treatment that mimics cellular activity in the
body’s immune system
Note 1 to entry: In immunotherapy, scientists create monoclonal antibodies in a laboratory that are designed to
recognize and bind to the antigen of a specific cancer c
...