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: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• 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: 29-Nov-2019
• Completion Date: 13-Nov-2019

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

IEC 60747-14-10:2019-11(en-fr)

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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




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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– 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

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IEC 60747-14-10:2019 © IEC 2019 – 3 –
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

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

SEMICONDUCTOR DEVICES –

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

FOREWORD
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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.

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IEC 60747-14-10:2019 © IEC 2019 – 5 –
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.

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colour printer.

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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.

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IEC 60747-14-10:2019 © IEC 2019 – 7 –
Glucose
Oxidation
V
of glucose
By-product
-
of glucose
e

IEC
Figure 1 – Schematic of the electrochemical reaction of glucose


Electrode

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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

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IEC 60747-14-10:2019 © IEC 2019 – 9 –
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.

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– 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

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IEC 60747-14-10:2019 © IEC 2019 – 11 –
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.

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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 locat
...