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
Current Stage
PPUB - Publication issued
Completion Date
13-Nov-2019
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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
IEC 60747-14-10:2019-11(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
– 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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– 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

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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.

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.
---------------------- Page: 7 ----------------------
– 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.

---------------------- Page: 8 ----------------------
IEC 60747-14-10:2019 © IEC 2019 – 7 –
Glucose
Oxidation
of glucose
By-product
of glucose
IEC
Figure 1 – Schematic of the electrochemical reaction of glucose
Electrode
---------------------- Page: 9 ----------------------
– 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
---------------------- Page: 10 ----------------------
IEC 60747-14-10:2019 © IEC 2019 – 9 –
3.1.2
working electrode
electrode where the reaction of interest occurs in an electrochemical system
3.1.3
counter electrode

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

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.
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.
---------------------- Page: 11 ----------------------
– 10 – IEC 60747-14-10:2019 © IEC 2019
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
---------------------- Page: 12 ----------------------
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
sensitivity= [A/mmol/l] (1)
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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– 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 locat

...

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