ISO 28218:2010

INTERNATIONAL ISO
STANDARD 28218
First edition
2010-10-01
Radiation protection — Performance
criteria for radiobioassay
Radioprotection — Critères de performance pour l'analyse
radiotoxicologique
Reference number
©
ISO 2010
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ii © ISO 2010 – All rights reserved

Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.2
3 Terms and definitions .2
4 Symbols.6
5 Performance measures.7
* #
5.1 Decision threshold (y ) and detection limit (y ).7
5.2 Relative bias and bias performance criteria.10
5.3 Repeatability performance criteria .12
6 Performance criteria for in vivo radiobioassay.12
6.1 General .12
6.2 Responsibilities of the customer that could impact the service laboratory's performance .12
6.3 Service laboratory criteria .12
6.4 Identification of radionuclides .13
6.5 Quantification .13
6.6 Reporting results.14
6.7 Records retention.15
7 Performance criteria for in vitro radiobioassay .15
7.1 General .15
7.2 Responsibilities of the customer that could impact the service laboratory's performance .15
7.3 Analytical methodology.16
7.4 Reporting results.17
7.5 Records retention.17
8 Quality assurance and quality control for radiobioassay laboratories .18
8.1 General .18
8.2 Quality assurance.18
8.3 Quality assurance plan .19
8.4 Quality control .20
9 Performance testing programme.21
9.1 General .21
9.2 In vivo radiobioassay.22
9.3 In vitro radiobioassay .25
Annex A (informative) Detection limit — Models for applications.29
Annex B (informative) Detection limit — Application examples .32
Bibliography.45

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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 28218 was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies, and
radiological protection, Subcommittee SC 2, Radiological protection.
This first edition of ISO 28218 cancels and replaces ISO 12790-1:2001, which has been technically revised.
iv © ISO 2010 – All rights reserved

Introduction
In the course of employment, individuals might work with radioactive materials that, under certain
circumstances, could be taken into the body. Radiation protection programmes for these individuals can
include means for in vivo or in vitro measurements of radioactive material that has entered the body. The
performance criteria required for such measurements usually depend upon the purpose for the radiobioassay
measurement, which can include determining the internal human burden of radioactive material, estimating
doses and dose commitments, radiation protection management, medical management when appropriate,
and providing the necessary data for legal and record-keeping requirements.
Analytical methods for radiobioassay are not currently standardized, but are available in the literature.
Guidance on the evaluation of data from the monitoring of workers occupationally exposed to the risk of
internal contamination by radioactive substances is provided in ISO 27048 as well as other publications of
national and international regulations and guides, the International Commission on Radiological Protection
(ICRP), the National Council on Radiation Protection and Measurement (NCRP), the International Atomic
Energy Agency (IAEA) and the International Commission on Radiological Units and Measurements (ICRU).
Recommendations of the ICRP, NCRP, IAEA and ICRU, as well as experience with the practical application of
these recommendations to the conduct of radiobioassay services and the interpretation and use of
radiobioassay results in radiation protection programmes, have been considered in the development of this
International Standard.
In addition to superseding ISO 12790-1:2001, this International Standard complements the requirements of
ISO 20553. This International Standard develops, expands and applies the principles defined in the
aforementioned standards for radiobioassay laboratories. It also provides a consensus on the statistical
definitions and formulations of the quantitative performance criteria of decision threshold, detection limit,
relative bias and repeatability. These concepts follow the requirements of ISO 11929. In particular, the
concept of minimum detectable amount (MDA) used in ISO 12790-1:2001 has been abandoned in favour of
#
detection limit (y ).
Clauses 5 to 8 primarily provide guidance for radiobioassay service laboratories, whereas Clause 9 relates to
testing laboratories and provides criteria for performance testing. The information in these clauses provides
beneficial insight for service laboratories, for users of the laboratory's services, and for testing laboratories, and
it provides a possible basis for an inter-laboratory quality assurance plan.
In this International Standard, the following verbal forms apply:
⎯ “shall” is used to denote a requirement;
⎯ “should” is used to denote a recommendation;
⎯ “may” is used to denote permission (neither a requirement nor a recommendation).
To conform with this International Standard, all radiobioassay needs to be performed in accordance with its
requirements, but not necessarily with its recommendations; however, justification needs to be documented for
deviations from recommendations.

INTERNATIONAL STANDARD ISO 28218:2010(E)

Radiation protection — Performance criteria for radiobioassay
1 Scope
This International Standard provides criteria for quality assurance and control, and evaluation of performance
of radiobioassay service laboratories.
Criteria and guidance for in vivo radiobioassay and in vitro radiobioassay are given in separate clauses.
The following are within the scope of this International Standard:
⎯ the accuracy of
⎯ in vivo measurements of activity and quantities of selected important radionuclides in test phantoms,
and
⎯ in vitro measurements of activity and quantities of selected important radionuclides in test samples;
⎯ minimal requirements for detection limit;
⎯ minimum testing levels and testing ranges;
⎯ requirements for reporting radiobioassay results by service laboratories;
⎯ quality assurance in service laboratories;
⎯ quality control in service laboratories;
⎯ protocol for reporting test evaluations by service laboratories to the testing laboratory;
⎯ default procedures when the service laboratory customer does not specify the performance criteria;
#
⎯ applications of y for different methods (see Annexes A and B).
The following are not within the scope of this International Standard:
⎯ detailed radiochemical methods for separating radionuclides from biological samples;
⎯ detailed procedures for in vivo and in vitro radioactivity measurements;
⎯ biokinetic data and mathematical models for converting radiobioassay results into dose (dose
assessment);
⎯ procedures for the preparation and distribution of test samples and phantoms by the testing laboratories.
2 Normative references
The following referenced documents are indispensable for the application 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/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms
(VIM)
ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General
principles and definitions
ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method
for the determination of repeatability and reproducibility of a standard measurement method
ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate
measures of the precision of a standard measurement method
3 Terms and
...