IEC 60747-14-10:2019

Semiconductor devices - Part 14-10: Semiconductor sensors - Performance evaluation methods for wearable glucose sensors

IEC 60747-14-10:2019 specifies the terms, definitions, symbols, tests, and performance evaluation methods used to determine the performance characteristics of wearable electrochemical-glucose sensors for practical use. This document is applicable to all wearable electrochemical-glucose sensors for consumers and manufacturers, without any limitations on device technology and size.

Dispositifs à semiconducteurs - Partie 14-10 : Capteurs à semiconducteurs - Méthodes d’évaluation des performances des capteurs de glucose implantables

L’IEC 60747-14-10:2019 spécifie les termes, les définitions, les symboles, les essais et les méthodes d’évaluation des performances utilisées pour déterminer les caractéristiques de performance des capteurs électrochimiques de glucose implantables à des fins pratiques. Le présent document est applicable à tous les capteurs électrochimiques de glucose implantables destinés aux consommateurs et aux fabricants, sans limitation concernant la technologie et les dimensions du dispositif.

General Information

• Status: Published
• Publication Date: 12-Nov-2019
• ICS: 31.080.01 - Semiconductor devices in general
• Technical Committee: SC 47E - Discrete semiconductor devices
• Drafting Committee: WG 1 - TC 47/SC 47E/WG 1
• Current Stage: PPUB - Publication issued
• Start Date: 13-Nov-2019
• Completion Date: 29-Nov-2019

Overview

IEC 60747-14-10:2019 is an international standard developed by the International Electrotechnical Commission (IEC) focused on the performance evaluation methods for wearable electrochemical glucose sensors. This standard defines the terms, definitions, symbols, tests, and methodologies essential for assessing the performance characteristics of wearable glucose sensors used for continuous glucose monitoring.

This document applies universally to all wearable electrochemical-glucose sensors regardless of technology or size, making it an essential reference for sensor manufacturers, healthcare device developers, and quality assurance professionals in the medical device industry.

Key Topics

• Performance Evaluation Methods
  The standard details comprehensive test methods to evaluate key performance parameters of wearable glucose sensors, including sensitivity, selectivity, response time, linearity, repeatability, reliability, and limit of detection.

• In Vitro and Clinical Testing Protocols
  IEC 60747-14-10:2019 specifies in vitro test setups to simulate glucose responses and clinical evaluation procedures to validate sensor performance in practical use scenarios.

• Characteristic Parameters and Ratings
  Definitions for essential ratings such as limiting values, operating conditions, and additional sensor characteristics are standardized to ensure consistency in performance claims.

• Electrochemical Sensor Configurations
  The document covers typical sensor designs, including two-electrode and three-electrode systems, and details electrochemical reaction mechanisms fundamental to glucose detection.

• Interference and Accuracy Assessment
  It identifies potential interfering substances that may affect sensor accuracy. The standard also incorporates error grid analyses such as the Consensus Error Grid and ISO 15197:2013 error grid, used for interpreting clinical sensor accuracy.

• Preclinical and Clinical Evaluation Procedures
  Steps for conducting animal model tests (preclinical investigation) and human trials (clinical evaluation) are outlined to verify sensor functionality and safety before commercial distribution.

Applications

• Wearable Medical Devices
  Crucial for developers of continuous glucose monitoring (CGM) systems that provide diabetes patients with non-invasive or minimally invasive glucose tracking.

• Consumer Health Technology
  Assists manufacturers designing wearable health trackers that incorporate glucose sensing capabilities, ensuring product reliability and user safety.

• Quality and Regulatory Compliance
  Supports compliance with medical device regulations by providing standardized performance metrics and testing protocols accepted in international markets.

• Research and Development
  Enables researchers working on novel semiconductor sensor materials and designs to benchmark and validate sensor effectiveness through standardized methods.

Related Standards

• IEC 60747 Series
  Part of the broader IEC 60747 standards on semiconductor devices, focusing on sensor technologies and related performance criteria.

• ISO 15197:2013
  Specifies requirements for glucose monitoring systems for self-testing in managing diabetes, complementing IEC 60747-14-10:2019 in clinical accuracy assessment.

• ISO/IEC Directives, Part 2
  The standard adheres to these directives ensuring high-quality drafting and international harmonization of technical content.

---

Keywords: wearable glucose sensors, electrochemical glucose sensor, sensor performance evaluation, IEC 60747-14-10, continuous glucose monitoring, semiconductor sensors, clinical evaluation, in vitro testing, glucose sensor accuracy, medical device standards, glucose monitoring technology, diabetes care devices.

Standards Content (Sample)

IEC 60747-14-10 ®
Edition 1.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Semiconductor devices –
Part 14-10: Semiconductor sensors – Performance evaluation methods for
wearable glucose sensors
Dispositifs à semiconducteurs –
Partie 14-10: Capteurs à semiconducteurs – Méthodes d’évaluation
des performances des capteurs de glucose implantables

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IEC 60747-14-10 ®
Edition 1.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Semiconductor devices –
Part 14-10: Semiconductor sensors – Performance evaluation methods for

wearable glucose sensors
Dispositifs à semiconducteurs –

Partie 14-10: Capteurs à semiconducteurs – Méthodes d’évaluation

des performances des capteurs de glucose implantables

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 31.080.01 ISBN 978-2-8322-7564-1

– 2 – IEC 60747-14-10:2019 © IEC 2019
CONTENTS
FOREWORD . 4
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
3.1 General terms . 6
3.2 Characteristic parameters . 11
4 Essential ratings and characteristic parameters . 13
4.1 Identification and type . 13
4.2 Limiting values and operating conditions . 13
4.3 Additional information . 13
5 Test method . 13
5.1 General . 13
5.2 In vitro evaluation . 15
5.2.1 Test procedure . 15
5.2.2 Sensitivity . 16
5.2.3 Selectivity . 16
5.2.4 Response time . 17
5.2.5 Linearity . 17
5.2.6 Repeatability . 18
5.2.7 Reliability. 18
5.2.8 Limit of detection . 19
5.2.9 Regression equation between output value and concentration . 19
5.2.10 Matching data between output value and concentration . 20
5.3 Preclinical investigation . 21
5.3.1 Test protocol . 21
5.3.2 Effectiveness of evaluation procedure . 21
5.3.3 Analytical performance evaluation . 22
5.4 Clinical evaluation . 24
5.4.1 Test protocol . 24
5.4.2 Clinical investigation procedure . 24
5.4.3 Analytical performance evaluation . 25
Annex A (informative) Possible interfering substances . 26
A.1 Purpose . 26
A.2 List of the possible interfering substances . 26
Annex B (informative) Consensus error grid . 27
B.1 Purpose . 27
B.2 Graphs . 27
B.3 Table . 28
Annex C (informative) ISO 15197:2013 error grid . 29
C.1 Purpose . 29
C.2 Graphs . 29
Bibliography . 32

Figure 1 – Schematic of the electrochemical reaction of glucose . 7
Figure 2 – Schematic of the wearable and wireless glucose sensor system . 8
Figure 3 – Configuration of the three-electrode system . 9

Figure 4 – Configuration of the two-electrode system . 10
Figure 5 – Possible insertion location of the wearable glucose sensor . 10
Figure 6 – In vitro test and evaluation set-up for the wearable electrochemical-glucose
sensor . 14
Figure 7 – Preclinical test and evaluation set-up for the wearable electrochemical-

glucose sensor . 14
Figure 8 – Clinical test and evaluation set-up for the wearable electrochemical-glucose
sensor . 15
Figure 9 – In vitro measurement procedure of the glucose sensor . 15
Figure 10 – Sensitivity of the glucose sensor . 16
Figure 11 – Selectivity of the glucose sensor . 16
Figure 12 – Response time of the glucose sensor . 17
Figure 13 – Linearity of the glucose sensor . 18
Figure 14 – Repeatability of the glucose sensor . 18
Figure 15 – Reliability of the glucose sensor . 19
Figure 16 – Limit of detection of the glucose sensor . 19
Figure 17 – Regression analysis between output value and reference glucose value . 20
Figure 18 – Preclinical test procedure of glucose . 21
Figure 19 – Glucose clinical test procedure . 24
Figure B.1 – Consensus error grid (mmol/l) . 27
Figure B.2 – Consensus error grid (mg/dl) . 28
Figure C.1 – Error grid adapted from ISO 15197:2013: Measured glucose value-
concentration plot (mg/dl) . 29
Figure C.2 – Error grid adapted from ISO 15197:2013: Measured glucose value-
concentration plot (mmol/l) . 30
Figure C.3 – Error grid adapted from ISO 15197:2013: Difference-concentration plot
(mg/dl) . 30
Figure C.4 – Error grid adapted from ISO 15197:2013: Difference-concentration plot
(mmol/l) . 31

Table 1 – Table of specifications for the wearable electrochemical-glucose sensor . 13
Table 2 – Matching table between output value and reference glucose value . 20
Table 3 – Glucose concentration intervals for the measurement of repeatability,

reliability, and accuracy . 22
Table 4 – Glucose concentration of samples for accuracy evaluation . 23
Table B.1 – Risk categories . 28

– 4 – IEC 60747-14-10:2019 © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SEMICONDUCTOR DEVICES –
Part 14-10: Semiconductor sensors –
Performance evaluation methods for wearable glucose sensors

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60747-14-10 has been prepared by subcommittee 47E: Discrete
semiconductor devices, of IEC technical committee 47: Semiconductor devices.
The text of this International Standard is based on the following documents:
FDIS Report on voting
47E/679/FDIS 47E/686/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

A list of all parts of the IEC 60747 series, published under the general title Semiconductor
devices, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 60747-14-10:2019 © IEC 2019
SEMICONDUCTOR DEVICES –
Part 14-10: Semiconductor sensors –
Performance evaluation methods for wearable glucose sensors

1 Scope
This part of IEC 60747-14 specifies the terms, definitions, symbols, tests, and performance
evaluation methods used to determine the performance characteristics of wearable
electrochemical-glucose sensors for practical use. This document is applicable to all wearable
electrochemical-glucose sensors for consumers and manufacturers, without any limitations on
device technology and size.
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 15197:2013, In vitro diagnostic test systems – Requirements for blood glucose monitoring
systems for self-testing in managing diabetes mellitus
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:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1 General terms
3.1.1
electrochemical-glucose sensor
sensor with which the glucose level is measured electrochemically using the redox of glucose
through a three- or two-electrode system
Note 1 to entry: Figure 1 shows the basic principle of electrochemical reaction of glucose.
Note 2 to entry: Figure 2 shows several examples of the wearable glucose sensors and systems.

Glucose
Oxidation
V
of glucose
By-product
-
of glucose
e
IEC
Figure 1 – Schematic of the electrochemical reaction of glucose

Electrode
– 8 – IEC 60747-14-10:2019 © IEC 2019
Skin
Epidermis
Wireless
communication
Dermis
Skin
Epidermis
Dermis
Skin
Epidermis
Dermis
Electrode Connector Module
IEC
Key
Components of the wearable and wireless glucose system
Intermediate between the sensor
Electrode Three electrodes of the glucose sensor Connector
that can measure and record glucose electrode and module.
concentration from interstitial fluid or
blood.
Module Includes a system with a convertor,
signal processing circuit, wireless
communication circuit, and bias circuit.
Epidermis Composed of the outermost layers of Dermis The layer of skin between the
cells in the skin. epidermis (with which it makes up the
cutis) and subcutaneous tissues that
consists of connective tissue and
cushions the body from stress and
strain.
Figure 2 – Schematic of the wearable and wireless glucose sensor system

3.1.2
working electrode
WE
electrode where the reaction of interest occurs in an electrochemical system
3.1.3
counter electrode
CE
electrode, also called auxiliary electrode, used in a three-electrode electrochemical cell for
voltammetric analysis or other reactions in which an electrical current is expected to flow
3.1.4
reference electrode
RE
electrode that acts as a reference to measure and control the required working potential,
regardless of current flow
3.1.5
three-electrode system
electrochemical system comprising a working electrode, counter electrode, and reference
electrode
Note 1 to entry: Figure 3 describes the configuration of the three-electrode system in the electrochemical glucose
measurement system.
Note 2 to entry: In the three-electrode system, the reference electrode is typically close to the working electrode
so that it can accurately adjust its potential. Current does not flow into the reference electrode, but does flow into
the counter electrode. The three-electrode system applies potential between the working and counter electrodes,
and measures amperometric current flowing from the working electrode to the counter electrode. As the three-
electrode system is able to apply stable and accurate potential through the reference electrode, it is used for the
investigation of the mechanism of electrochemical reactions, electrochemical analysis, and to obtain various
parameters.
A
V
CE RE WE
Electrolyte solution
IEC
Figure 3 – Configuration of the three-electrode system
3.1.6
two-electrode system
electrochemical system comprising a working electrode and counter/reference electrode
Note 1 to entry: Figure 4 describes the configuration of the two-electrode system in the electrochemical glucose
measurement system.
– 10 – IEC 60747-14-10:2019 © IEC 2019
A
V
CE WE
Electrolyte solution
IEC
Figure 4 – Configuration of the two-electrode system
3.1.7
wearable glucose sensor
glucose sensor that is intended to be totally or partially introduced, surgically or medically,
into the human body to measure glucose levels through the blood or interstitial fluid, and
which is intended to remain in place following the procedure or mounted on human skin
Note 1 to entry: Figure 5 describes three types of wearable glucose sensors. Implant-type glucose sensors are
located under the skin either in the epidermis, dermis, or other tissue. Patch-type glucose sensors are located on
the skin, and are partially inserted and exposed.
Skin
Implant glucose sensor
Epidermis
Implant type
glucose sensor
Dermis
Patch type glucose sensor
Skin
Epidermis
Dermis
IEC
Figure 5 – Possible insertion location of the wearable glucose sensor
3.1.8
amperometric response
current response of the glucose sensor caused by a change in the glucose concentration
under the working potential
3.1.9
working potential
optimal potential of the working electrode that maximizes the amperometric response of
glucose and minimizes the amperometric response of interference

3.1.10
interference
bio-reagents present in bio-fluids such as blood and interstitial fluid, which can indicate a
larger amperometric response than that of glucose in the glucose sensor and can interfere
with the measurement of glucose levels
Note 1 to entry: All interferences that affect the electrochemical response to glucose during measurement are
listed in Annex A.
3.1.11
in vitro evaluation
evaluation of glucose and other bio-reagents performed outside the animal or human body
3.1.12
preclinical evaluation
stage of research that begins before clinical evaluation (testing in humans), and during which
important feasibility, iterative testing, and drug safety data are collected through safety and
effectiveness evaluation
Note 1 to entry: "Preclinical investigation", "preclinical test", "preclinical development", or "preclinical study" are
synonymous with "preclinical evaluation".
3.1.13
clinical evaluation
systematic investigation in one or more human subjects, undertaken to assess the safety or
performance of a medical device
Note 1 to entry: ”Clinical investigation” “clinical test”, “clinical development”, or “clinical study” are synonymous
with “clinical evaluation”.
[SOURCE: ISO 14155:2011, 3.6]
3.2 Characteristic parameters
3.2.1
sensitivity
quotient of the change in the glucose concentration of a measurement system and the
corresponding change in the current being measured, which can be
∆I
sensitivity= [A/mmol/l] (1)
∆C
where
I is current
C is concentration
Note 1 to entry: The sensitivity of a measurement system can depend on the value of the quantity being
measured.
Note 2 to entry: The change in the value of the quantity being measured is larger compared with the resolution.
3.2.2
selectivity
parameter that can detect a certain analyte and not react with admixtures and contaminants
such as interference from acetaminophen and ascorbic acid
Note 1 to entry: All interferences that affect the electrochemical response of glucose during measurement are
listed in Annex A.
– 12 – IEC 60747-14-10:2019 © IEC 2019
3.2.3
response time
duration between the instant when the prior amperometric response is stable before the
glucose concentration changes and the instant when the amperometric response reaches a
final value following the change in glucose concentration
3.2.4
linearity
mathematical relationship or function that can be graphically represented as a straight line, as
in the glucose concentration and electrochemical response that are directly proportional to
each other
3.2.5
repeatability
measurement precision under a set of repeatability conditions that include the same
measurement procedure, operators, measurement system, operating conditions, and location,
and replicate measurements on the same or similar objects over a short period of time
Note 1 to entry: A condition of measurement is a repeatability condition only with respect to a specified set of
repeatability conditions.
3.2.6
reliability
measurement precision under a set of reliability conditions that include the same
measurement procedure, operators, measurement system, operating conditions, and location,
and replicate measurements on the same or similar objects over a long period time
3.2.7
limit of detection
LOD
smallest reliable measurable quantity value, called resolution, that the glucose sensor is able
to make
Note 1 to entry: This note applies to the French language only.
3.2.8
reproducibility
measurement precision under reproducibility conditions that include different locations,
operators, measurement systems, and replicate measurements on the same or similar objects
Note 1 to entry: The different measurement systems use different measurement procedures.
Note 2 to entry: Specification gives the conditions changed and unchanged.
3.2.9
life-time
statistical measurement of how long the glucose sensor may work
3.2.10
accuracy
closeness of agreement between a measured quantity value of glucose concentration and a
true quantity value of reference glucose concentration
Note 1 to entry: Accuracy is analyzed through error grid analysis.

4 Essential ratings and characteristic parameters
4.1 Identification and type
The wearable electrochemical-glucose sensors shall be clearly and durably marked in the
order given below:
a) year and week (or month) of manufacture;
b) manufacturer name or trade mark;
c) terminal identification (optional);
d) serial number;
e) factory identification code (optional).
4.2 Limiting values and operating conditions
The manufacturer shall clearly indicate the operating conditions and limitations for the use of
the wearable glucose sensor. Table 1 shows a list of specifications for operating conditions
and limitations.
Table 1 – Table of specifications for the wearable electrochemical-glucose sensor
Measuring
a b c d e
Parameter Symbol Min. Max. Unit
f
condition
a
Name of characteristic parameters
b
Symbol of parameters
c
Minimum value of parameters
d
Maximum value of parameters
e
Specified condition for evaluation
f
Specified condition for evaluation

4.3 Additional information
Some additional information should be given, such as operating conditions (e.g. operating
temperature, storage temperature, input voltage, equivalent circuit, and power consumption,
etc.), handling precautions, physical information (e.g. outline dimensions, terminals, etc.),
accessories, installation guide, package information, PCB interface and mounting information,
and any other relevant information.
5 Test method
5.1 General
The sequence of general test procedures for the wearable electrochemical-glucose sensors is
shown in Figure 6, Figure 7, and Figure 8. After the glucose sensor has been mounted on the
test module, the level of glucose is measured by applying potential with an electrochemical
analyzer. The wearable electrochemical-glucose sensor is evaluated in the sequence of in
vitro, preclinical, and clinical tests. For the preclinical and clinical tests, the wearable sensor
is usually integrated and assembled with signal analysis circuitry and a communication
module for wireless and continuous monitoring.

– 14 – IEC 60747-14-10:2019 © IEC 2019
RE
WE
CE
Electrochemical
analyzer
RE WE CE
Glucose sensor
0,1 M PBS (pH 7,4)
Electrochemical analysis
Measurement setting Result monitoring
equipment
IEC
NOTE In order to characterize the patch- and implant-type glucose sensors, each sensor is dipped into 0,1 M
phosphate buffered saline (PBS) (pH 7,4), and potential, such as a constant or specific waveform, is applied to the
glucose sensor. The investigator measures the change in the current response as the glucose concentration varies,
and analyzes the parameters of sensitivity, selectivity, response time, repeatability, reproducibility, limit of
detection, and life-time.
Figure 6 – In vitro test and evaluation set-up for the wearable
electrochemical-glucose sensor
Skin
Implant type glucose sensor
Epidermis
Implant type
glucose sensor
Dermis
Implant into epidermis or dermis of animal Result monitoring
Patch type glucose sensor
Skin
Epidermis
Dermis
Result monitoring
Put on skin of animal
IEC
Figure 7 – Preclinical test and evaluation set-up for the wearable
electrochemical-glucose sensor

Skin
Implant type glucose sensor
Epidermis
Implant type
glucose sensor
Dermis
Implant into epidermis or dermis of subject Result monitoring
Patch type glucose sensor
Skin
Epidermis
Dermis
Result monitoring
Put on skin of subject
IEC
Figure 8 – Clinical test and evaluation set-up for the wearable
electrochemical-glucose sensor
5.2 In vitro evaluation
5.2.1 Test procedure
In vitro evaluation shall be conducted as shown in Figure 9. The following test procedure is
performed:
a) as shown in Figure 9, all the implements and reagents for evaluation of the glucose
sensor are set up;
b) reagents for in vitro evaluation include 0,1 M PBS, glucose solution, interferences,
electrochemical analyzer, and monitoring system. The 0,1 M PBS solution is the
background solution for all in vitro evaluations;
c) sensitivity, selectivity, response time, linearity, repeatability, and reliability analyses are
implemented;
d) evaluation of the glucose sensor is analyzed statistically or through the methods specified
below.
Set-up of experimental environments and test samples
Evaluation of sensitivity, selectivity, response time, linearity,
repeatability, reproducibility, limit of detection, and life-time
Embedding sensor and signal processor on module
(conversion of current response to glucose concentration)
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Figure 9 – In vitro measurement procedure of the glucose sensor

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5.2.2 Sensitivity
The current response of the glucose sensor during measurement, and the parameter that
indicates how much current flows according to glucose concentration.
In order to investigate the sensitivity of the glucose sensor, the glucose concentration is
progressively and gradually changed into specific values for a wide range of tests. Figure 10
shows a typical plotting of current versus glucose concentration. Sensitivity is defined as the
quantity of current according to glucose concentration.
9,0
8,5
8,0
7,5
7,0
6,5
0 2 4 6 8 10
Concentration (mM)
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Figure 10 – Sensitivity of the glucose sensor
5.2.3 Selectivity
A parameter that reacts to one reagent with good selectivity means that the glucose sensor
indicates a high current response to glucose only and a low current response to other
substances.
Figure 11 shows the results of a selectivity test. In order to evaluate the selectivity of the
glucose sensor, interferences such as ascorbic acid and acetaminophen are added to the
0,1 M PBS solution along with glucose at two specific concentrations.
Glucose
5 mmol
5 mM
–5
5 mM
–10
5 mM AA
0,1 mM
5 mM
–15 AP
5 mM
0,1 mM
–20
–25
–30
200 400 600 800 1 000
Time (s)
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Figure 11 – Selectivity of the glucose sensor
Current (µ A)
Current (µ A)
NOTE 1 All the interferences are listed in Annex A.
NOTE 2 The recommended concentrations of interferences are determined from the CLSI document EP07-A2:
Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition, see Bibliography.
NOTE 3 The concentrations of glucose in the 0,1 M PBS solution are intervals of 2,8 mmol/l to 5,5 mmol/l (50
mg/dl to 100 mg/dl) and intervals of 13,9 mmol/l to 19,4 mmol/l (250 mg/dl to 350 mg/dl).
5.2.4 Response time
This refers to the time taken for the amperometric response to reach a final value following a
change in glucose concentration. Figure 12 shows an example of how to calculate the
response time. The final value is defined as 90 % of the quantity of the current that reaches a
stable value.
–5
–10
–15
–20
–25
50 100 150 200
Time (s)
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Figure 12 – Response time of the glucose sensor
5.2.5 Linearity
The parameter that indicates how much of the current response to the glucose level is linear,
and how wide its range is. Figure 13 shows a plotting of current versus glucose concentration.
The scattered dots are plotted on the graph and fitted through a linear function.
Current (µ A)
90 %
100 %
– 18 – IEC 60747-14-10:2019 © IEC 2019
0,32
0,30
0,28
0,26
0,24
0,22
2 3 4 5 6 7 8
Concentration (mmol)
Equation y = a + b * x
Adj. R-squ 0,964
Value Standard Er
Current Intercept 1,967E-3 8,199 39E-9
Current Slope 1,35E-2 1,497E-9

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Figure 13 – Linearity of the glucose sensor
5.2.6 Repeatability
The parameter that determines how stable the glucose sensor is in the short-term.
Figure 14 shows a graph to evaluate repeatability. In order to evaluate the repeatability of the
glucose sensor, the amperometric response changed by repetition of the same test is
measured and recorded using the same method and conditions over a period of time less than
24 h.
–5
Average
st
–10
nd
rd
th
–15 th
Linear fit of current
0 2 4 6 8 10 12
Concentration (mmol)
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Figure 14 – Repeatability of the glucose sensor
5.2.7 Reliability
The parameter that determines how stable the glucose sensor is in the long-term (over a few
days).
Current (µ A)
Current (µ A)
Figure 15 shows a graph to evaluate the reliability. In order to evaluate the reliability of the
glucose sensor, the amperometric response changed by repetition of the same test is
measured and recorded using the same method conditions over a few days or longer.
During long-term measurement (over a few days), the investigators measure and compare the
deviation in the current response of the glucose sensor.
1,0
0,8
0,6
0,4
0,2
1 2 3 4 5 6 7
Day
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Figure 15 – Reliability of the glucose sensor
5.2.8 Limit of detection
This is the parameter that determines how low a concentration of glucose the glucose sensor
can measure. The limit of detection test is performed by adding a small amount of glucose.
Figure 16 shows the result of a limit of detection measurement as a small amount of the
glucose is injected. Signal-to-noise ratio (SNR) shall be more than 3 where the glucose
concentration is at the minimum limit of detection.
–0,5
–1,0
–1,5
50 µmol
–2,0
100 µmol
–2,5
–3,0 500 µmol
–3,5
–4,0
50 100 150 200 250 300 350
Time (s)
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Figure 16 – Limit of detection of the glucose sensor
5.2.9 Regression equation between output value and concentration
This equation determines the specific relation between the output value (or any output value,
such as current response, output voltage, and digit value) and the glucose value by
regression analysis so that the unknown glucose value is able to be determined by comparing
the glucose value (from the test device) to the reference. Figure 17 shows a graph to obtain
the correlation between the reference glucose values and the output of the glucose sensor.
Current (µ A) Sensitivity (µ A/mM)

– 20 – IEC 60747-14-10:2019 © IEC 2019
The curve-fitting equation between the reference glucose values and the output of the glucose
sensor can be expressed in many kinds of functions.
Reference glucose value =
(output) * 0,283 + (104,161)
100 150 200 250 300 350
Output (digit)
Equation y = a + b * x
Adj. R-squ 0,9537
Value Standard Er
Current Intercep 104,1611 5,04998
Current Slope 0,28269 0,02346
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NOTE The regression equation or matching data is selected in order to carry out the comparison.
Figure 17 – Regression analysis between output value and reference glucose value
5.2.10 Matching data between output value and concentration
Table 2 determines the specific relationship between the output value (or any output value,
such as the current response, output voltage, and digit value) and the glucose value by listing
the current response so that the unknown glucose value is able to be determined by
comparing the glucose value (from the test device) to the reference. Table 2 is a matching
table between the output values of the glucose sensor and the reference glucose values. The
matching data is presented as the average value of output in the same reference glucose
value.
NOTE The regression equation or matching data is selected.
Table 2 – Matching table between output value and reference glucose value
Output value Reference glucose concentration
(either in V or A) mmol/l (mg/dl)
93 1 (18)
126 2 (36)
151 3 (54)
182 4 (72)
216 5 (90)
etc. -
Refrence glucose value (mg/dl)

5.3 Preclinical investigation
5.3.1 Test protocol
Figure 18 shows a preclinical evaluation procedure. In order to test preclinical investigation,
the following test procedure is performed:
a) two kinds of evaluation are performed in parallel: effectiveness and safety evaluations;
b) the effectiveness evaluation is performed using surgical procedures with the glucose
sensor on animals such as guinea pigs or rabbits, after the investigator is approved by
Institutional Animal Care and Use Committee (IACUC);
c) the glucose levels of the animal are measured and recorded;
d) the safety evaluation is performed using seven tests;
e) following the completion of both the effectiveness and safety evaluations, reports are
written.
Employment of animal
(eg: guinea pig, rabbit, etc.)
Surgical procedure of glucose sensor on animal
(approval by IACUC)
Evaluation of glucose sensor and writing reports
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Figure 18 – Preclinical test procedure of glucose
5.3.2 Effectiveness of evaluation procedure
To evaluate the effectiveness of the wearable electrochemical-glucose sensors, the following
test procedure is performed.
a) An animal is prepared, along with the glucose sensor and blood analyzer for glucose
levels.
b) A surgical procedure to place the wearable electrochemical-glucose sensor on the
skin/epidermis/dermis is performed.
c) The glucose level
...