ISO 18310-2:2021

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 18310-2
ISO/TC 85/SC 2
Measurement and prediction of the
Secretariat: AFNOR
ambient dose equivalent from patients
Voting begins on:
2021-02-12 receiving iodine 131 administration
after thyroid ablation —
Voting terminates on:
2021-04-09
Part 2:
External effective dose of the
caregivers after release from the
hospital
Mesurage et prévision de l'équivalent de dose ambiant de patients
bénéficiant d'un traitement par iode 131 après ablation de la
thyroïde —
Partie 2: Dose externe efficace des proches après sortie
d’hospitalisation
RECIPIENTS OF THIS DRAFT ARE INVITED TO
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OF ANY RELEVANT PATENT RIGHTS OF WHICH
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DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 18310-2:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2021

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ISO/FDIS 18310-2:2021(E)

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© ISO 2021
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ISO/FDIS 18310-2:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements for the release of patient with caregiver . 3
4.1 Discharge criteria . 3
131
4.2 Management procedure of the patient receiving I administration . 3
4.3 Release from the medical facility . 3
4.4 Responsibility of the designated expert . 4
5 Measurement of the effective dose to the caregiver . 4
5.1 General . 4
5.2 Specifications of the personal dosimeter . 4
5.3 Measurement of the effective dose to the caregiver . 4
6 Quality control . 5
7 Uncertainty . 5
Annex A (informative) Examples of written instructions to be presented to patients or their
legal guardians before leaving the hospital after treatment with radioiodine .6
Annex B (informative) Experimental application to this document: measurement and
prediction of the effective dose to the caregiver in the vicinity of the patients
receiving radioiodine 131 administration after thyroid ablation .9
Bibliography .12
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ISO/FDIS 18310-2:2021(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
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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 on 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 the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies,
and radiological protection, Subcommittee SC 2, Radiological protection.
A list of all the parts in the ISO 18310 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 18310-2:2021(E)

Introduction
ISO 18310 series addresses methods and procedures for measuring ambient dose equivalent from
131
patients administered I for thyroid cancer therapy.
Thyroid cancer can be treated by administering radioiodine with the remnants after surgery, because
radioiodine selectively accumulates in thyroid tissue to irradiate and kill the cancerous cells. Thyroid
cancers are small and are not likely to develop into aggressive malignancies. Earlier diagnosis and
treatment can remove these cancers at a time when they are not likely to have spread beyond the
thyroid gland.
There are two common practices for the treatment of thyroid cancer: One is a radioiodine administration
without thyroid resection. The other is administration after thyroid resection. In recent years,
the radioiodine administration after surgery has become more common as radioiodine selectively
accumulates in thyroid tissue to irradiate and kill the cancerous cells.
131 131
The most commonly used radionuclide for the treatment is I. I is a radioisotope that emits gamma
131
rays following beta rays. The primary emissions of I decay are thus electrons with a maximal energy
of 606 keV (89 % abundance, others 248 keV – 807 keV) and 364 keV gamma rays (81 % abundance,
others 723 keV). Since the abundance of 364 keV gamma-ray is much greater than other gamma-
ray energies, the main contribution to the ambient dose equivalent is from 364 keV gamma-ray. Its
radiological half-life is 8,02 d. The iodine is administered orally and is absorbed in the gastrointestinal
tract. Most iodine subsequently travels through the blood and is available in the circulation for uptake
by the thyroid gland and urinary excretion; the remainder is excreted in faeces, sweat, saliva and breast
[1]
milk in organic form. For patients who have had their thyroid removed, the retention time in the body
is shorter than that of patients who have not had their thyroid removed.
Patients who receive radioiodine treatment for thyroid cancer emit radiation and represent a potential
hazard to other individuals. Critical groups among the public are fellow travellers on the patient’s trip
back home from the hospital, members of the patient’s family, close friends, caregivers and comforters.
For the purpose of the ISO 18310 series, this document focus on the determination of the effective dose
to the caregiver in the vicinity of the patient treated with radioiodine. It is based on the estimation of
the effective dose using a personal dosimeter worn by the caregiver. The uncertainty of the effective
dose is also provided.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 18310-2:2021(E)
Measurement and prediction of the ambient dose
equivalent from patients receiving iodine 131
administration after thyroid ablation —
Part 2:
External effective dose of the caregivers after release from
the hospital
1 Scope
This document addresses the measurement methods, procedures and uncertainty estimation for the
measurement, using a personal dosimeter, of the effective dose to the caregiver in the vicinity of the
patient treated with radioiodine to ablate the thyroid.
The general requirements for the patient and caregiver and a guidance (see Annex A) for designated
expert on instructing caregivers of discharged patients is considered to effectively measure the
effective dose to the caregiver in the vicinity of the patient.
2 Normative references
The following document is referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 4037-1, Radiological protection — X and gamma reference radiation for calibrating dosemeters and
doserate meters and for determining their response as a function of photon energy — Part 1: Radiation
characteristics and production methods
ISO 4037-2, Radiological protection — X and gamma reference radiation for calibrating dosemeters and
doserate meters and for determining their response as a function of photon energy — Part 2: Dosimetry for
radiation protection over the energy ranges from 8 keV to 1,3 MeV and 4 MeV to 9 MeV
ISO 4037-3, Radiological protection — X and gamma reference radiation for calibrating dosemeters and
doserate meters and for determining their response as a function of photon energy — Part 3: Calibration of
area and personal dosemeters and the measurement of their response as a function of energy and angle of
incidence
ISO 4037-4, Radiological protection — X and gamma reference radiation for calibrating dosemeters and
doserate meters and for determining their response as a function of photon energy — Part 4: Calibration of
area and personal dosemeters in low energy X reference radiation fields
ISO 18310-1, Measurement and prediction of the ambient dose equivalent from patients receiving iodine
131 administration after thyroid ablation — Part 1: During the hospitalization
ISO 29661, Reference radiation fields for radiation protection — Definitions and fundamental concepts
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
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ISO/FDIS 18310-2:2021(E)

3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4037-1 to ISO 4037-4,
ISO/IEC Guide 99, ISO 29661 and the following 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
caregiver
individual such as a family member, close friend, or accompanying person who willingly and voluntarily
takes care of a discharged patient treated with radioiodine to ablate the thyroid remnants
3.2
calibration
operation under specified conditions that, in a first step, establishes a relation between the quantity
values with measurement uncertainties provided by measurement standards and corresponding
indications with associated measurement uncertainties and, in a second step, uses this information to
establish a relation for obtaining a measurement result from an indication
3.3
effective dose
tissue-weighted sum of the equivalent doses in all specified tissues and organs of the body
3.4
electronic personal dosimeter
EPD
electronic device used for continual monitoring with live readout of accumulated radiation dose due to
ionizing radiation
3.5
optically simulated luminescence dosimeter
OSLD
radiation dosimeter used to measure ionizing radiation exposure from electrons trapped between the
valence and conduction bands in the crystalline structure of certain minerals by optical stimulation of
the material to emit light of a different wavelength
3.6
personal dosimeter
device, such as an electronic personal dosimeter (3.4), optically simulated luminescence (3.5),
radiophotoluminescent glass dosimeter (3.8) or thermoluminescent dosimeter (3.9), used for monitoring
the personnel cumulative radiation dose due to ionizing radiation
3.7
131
I
131
iodine 131 ( I) that decays with a half-life of 8,02 d with beta and gamma emissions
131
Note 1 to entry: On decaying, I most often (89 % of the time) expend 971 keV of decay energy by transforming
131 131
into stable Xe in two steps with gamma decay following rapidly after beta decay. The primary emissions of I
decay are beta particles with maximum energy of 606 keV and gamma rays of energy 364 keV. Major application
131
of I is for the direct radioisotope therapy to treat hyperthyroidism and some types of thyroid cancer.
3.8
radiophotoluminescent glass dosimeter
RPLD
radiation dosimeter which uses glass compound as the luminescent material
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ISO/FDIS 18310-2:2021(E)

3.9
thermoluminescent dosimeter
TLD
radiation dosimeter used to measure ionizing radiation exposure from electrons trapped between
the valence and conduction bands in the crystalline structure of certain minerals by measuring the
intensity of light emitted from a crystal in the detector when the crystal is heated
4 General requirements for the release of patient with caregiver
4.1 Discharge criteria
131
Discharge of an in-patient treated with I is permitted only if the dose to family, close friends, and
third persons due to the residual activity in the patient is not expected to exceed dose constraints
approved by the competent authorities.
The recommendations by the International Commission on Radiological Protection (ICRP) and the
standards of International Atomic Energy Agency (IAEA) stipulate a dose limit of 1 mSv/y to the general
public and 5 mSv per treatment to relatives, visitors, and caregivers of patients upon release of patients
[2]
treated with radionuclide from hospitals. Further, ICRP 94 recommends applying an annual dose
limit of 1 mSv to embryos/fetuses, infants, and children, which is a small group with higher sensitivity,
in lieu of a dose limit of 5 mSv per treatment.
The Nuclear Regulatory Commission (USNRC) in the United States indicates in Table U.1 of Reference [3]
that the derived residual radioactivity of 1,2 GBq or a spatial dose rate of 70 μSv/h at a distance of one
metre computes to an effective dose of 5 mSv to other persons at isolation or release of patients from
the hospital.
Certain requirements should be met when discharging the patient. The responsible designated expert is
to ensure that relevant dose measurements are performed, and that instructions are given to patients,
both orally and in writing. The physician is to ensure that the patient comprehends the instructions to
reduce exposure to other persons, as well as living conditions at home.
131
4.2 Management procedure of the patient receiving I administration
The management procedures for the patient before, during and after treatment with radioiodine are as
follows:
a) Isolate the patient and restrict the patient and visitors from entering and exiting the room during
the radioactive iodine treatment. During the hospitalization, the patient is not allowed to leave
their room, and visitors are not allowed.
b) Increase fluid intake during hospitalization and after discharge. Instruct the patient to urinate
often even though he feels no urge to urinate and to flush the toilet twice after urination or faecal
discharge.
c) While the responsible designated expert continues to process the patient’s discharge, th
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