ISO/TS 23367-1:2022
(Main)Nanotechnologies — Performance characteristics of nanosensors for chemical and biomolecule detection — Part 1: Detection performance
Nanotechnologies — Performance characteristics of nanosensors for chemical and biomolecule detection — Part 1: Detection performance
This document describes the performance characteristics necessary to evaluate the detection performance of nanosensors for chemical and biomolecule detection. This document does not cover the analytical performance characteristics or the performance evaluation procedure of a specific sensor.
Nanotechnologies — Caractéristiques de performance des nanocapteurs pour la détection de molécules chimiques et de biomolécules — Partie 1: Performances de détection
General Information
Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 23367-1
First edition
2022-12
Nanotechnologies — Performance
characteristics of nanosensors for
chemical and biomolecule detection —
Part 1:
Detection performance
Nanotechnologies — Caractéristiques de performance des
nanocapteurs pour la détection de molécules chimiques et de
biomolécules —
Partie 1: Performances de détection
Reference number
ISO/TS 23367-1:2022(E)
© ISO 2022
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ISO/TS 23367-1:2022(E)
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ISO/TS 23367-1:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Detection performance characteristics . 3
4.1 General . 3
4.2 Detection sensitivity . 3
4.3 Detection specificity. 4
4.4 Detection signal ratio . 4
Annex A (informative) Performance evaluation of a sensor . 5
Annex B (informative) Limitations of existing detection performance characteristics on
nanosensor . 7
Bibliography .10
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ISO/TS 23367-1:2022(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 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 229 Nanotechnologies.
A list of all parts in the ISO 23367 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/TS 23367-1:2022(E)
Introduction
Nanostructured materials possess fascinating properties such as high reactivity, excellent electrical
conductivity, quantum-scaled confinement, great degree of biocompatibility, versatile optical
transmission, outstanding electromagnetic properties and substantial surface area-to-volume ratio.
Physical and chemical behaviour of nanomaterials are tunable by morphological variation as well as
surface modification. It is these unique properties and functionalities that enable nanomaterials to be a
novel solution for the development of advanced high-performance sensing devices.
Applications of advanced nanomaterials in the detection of chemicals or biomolecules have been
widely studied to cater to variety of demands from innovative healthcare practice to industrial
process improvement to potent environmental surveillance. By introducing nanotechnology in sample
preparations, biomolecule reactions and chemical sensing procedures, the performance of traditional
sensor technologies has been enhanced, brand-new nanosensors have been commercialized, and
related markets have achieved remarkable growth.
There are several standards that specify the performance characteristics and the performance
evaluation of a specific sensing or metrological device/equipment, especially in in vitro diagnosis,
food safety management and environmental monitoring. Existing standards describe the performance
of conventional sensors, however, there is not any standard document which generally addresses the
enhanced sensing performance of a nanosensor. Moreover, the enhancement of sensing performance
by nanotechnologies is not yet reflected in the existing relevant standards for conventional sensor
technologies. As a result, there is a growing need for standardization to accurately describe the
performance characteristics of nanosensors for chemical and biomolecule detection. This document
standardizes performance characteristics of nanosensors which are utilized for performance evaluation
in medical diagnosis, personal healthcare, environment monitoring, food quality and safety monitoring
and biohazard defence.
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TECHNICAL SPECIFICATION ISO/TS 23367-1:2022(E)
Nanotechnologies — Performance characteristics of
nanosensors for chemical and biomolecule detection —
Part 1:
Detection performance
1 Scope
This document describes the performance characteristics necessary to evaluate the detection
performance of nanosensors for chemical and biomolecule detection. This document does not cover the
analytical performance characteristics or the performance evaluation procedure of a specific sensor.
2 Normative references
The following documents are 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/IEC Guide 99:2007, International vocabulary of metrology — Basic and general concepts and
associated terms (VIM)
ISO 16604:2004, Clothing for protection against contact with blood and body fluids — Determination of
resistance of protective clothing materials to penetration by blood-borne pathogens — Test method using
Phi-X 174 bacteriophage
ISO 17511:2020, In vitro diagnostic medical devices — Requirements for establishing metrological
traceability of values assigned to calibrators, trueness control materials and human samples
ISO 18113-1:2022, In vitro diagnostic medical devices — Information supplied by the manufacturer
(labelling) — Part 1: Terms, definitions, and general requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99:2007,
ISO 16604:2004, ISO 17511:2020, ISO 18113-1 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
analyte
component represented in the name of a measurable quantity
EXAMPLE In the type of quantity "mass of protein in 24-hour urine", "protein" is the analyte. In "amount of
substance of glucose in plasma", "glucose" is the analyte. In both cases the long phrase represents the measurand
(3.9).
[SOURCE: ISO 17511:2020, 3.1]
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ISO/TS 23367-1:2022(E)
3.2
analytical performance
ability of an assay using a nanosensor to measure or detect a particular analyte in a
reference sample
3.3
assay
set of operations to determine the presence of or concentration of a particular component
[SOURCE: ISO 16604:2004, 3.2, modified — "analysis of a mixture" has been changed to "set of
operations" and Note 1 to entry has been deleted.]
3.4
cut-off value
quantity value used as a limit to identify samples that indicate the presence or the absence of a specific
disease, condition, or measurand
Note 1 to entry: The cut-off value defines which measurement results are reported as positive and which are
reported as negative.
Note 2 to entry: Measurement results near the cut-off value can be inconclusive due to measurement uncertainty.
Note 3 to entry: The selection of the cut-off value determines the clinical specificity and clinical sensitivity of the
examination.
[SOURCE: ISO 18113-1:2022, 3.2.15, modified — "decision limit" has been changed "limit" and Notes 1,2
and 3 to entry have been revised.]
3.5
detection performance
ability of an assay using a nanosensor to determine the presence of a particular analyte
above the cut-off value in a test sample
Note 1 to entry: A test sample is defined as a sample used to validate the performance of the nanosensor.
3.6
detection sensitivity
ability of an assay using a nanosensor to recognize the presence of an analyte in a test
sample
3.7
detection specificity
ability of an assay using a nanosensor to recognize the absence of an analyte in a test
sample
3.8
detection signal ratio
ability of an assay using a nanosensor to clearly differentiate a positive response from a
negative response
3.9
measurand
quantity intended to be measured
[SOURCE: ISO/IEC Guide 99:2007, 2.3, modified — Notes 1, 2, 3 and 4 to entry, and Examples 1 and 2
have been deleted.]
3.10
nanosensor
nano-enabled or nano-enhanced apparatus used to detect or identify events and changes in its
environment, and transmit features of data to other electronics to convert them to a measurable output
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ISO/TS 23367-1:2022(E)
3.11
performance characteristic
parameter used to define the performance of a nanosensor
EXAMPLE Sensitivity, specificity and signal ratio.
Note 1 to entry: Information about more than one performance characteristic is usually required to evaluate the
suitability of a nanosensor for its intended use.
3.12
performance evaluation
investigation of a device or apparatus for the purpose of establishing or verifying its
performance claims
4 Detection performance characteristics
4.1 General
Detection performance is the ability of an assay to discriminate between two subclasses of subjects,
and detection performance evaluation of the assay using a nanosensor is intended mainly to detect the
presence of a target chemical or biomolecule above a cut-off value. Examples of assays include the tests
[1] [2]
for infectious diseases in in vitro diagnosis, food poisoning in food quality and safety monitoring,
[3]
defective product screening in quality control and detection of biohazards in environmental
[4]
monitoring. In such cases, the assay is designed to distinguish between positive and negative
responses, i.e. between results above or below a pre-determined cut-off value.
Typical detection performance characteristics for conventional
...
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