EN ISO 15197:2003

SLOVENSKI STANDARD
01-september-2003
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In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for
self-testing in managing diabetes mellitus (ISO 15197:2003)
Testsysteme für die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme zur
Eigenanwendung beim Diabetes mellitus (ISO 15197:2003)
Systemes d'essais de diagnostic in vitro - Exigences relatives aux systemes
d'autosurveillance de la glycémie destinés a la prise en charge du diabete sucré (ISO
15197:2003)
Ta slovenski standard je istoveten z: EN ISO 15197:2003
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 15197
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2003
ICS 11.040.55
English version
In vitro diagnostic test systems - Requirements for blood-
glucose monitoring systems for self-testing in managing
diabetes mellitus (ISO 15197:2003)
Systèmes d'essais de diagnostic in vitro - Exigences Testsysteme für die In-vitro-Diagnostik - Anforderungen an
relatives aux systèmes d'autosurveillance de la glycémie Blutzuckermesssysteme zur Eigenanwendung beim
destinés à la prise en charge du diabète sucré (ISO Diabetes mellitus (ISO 15197:2003)
15197:2003)
This European Standard was approved by CEN on 25 April 2003.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15197:2003 E
worldwide for CEN national Members.

CORRECTED  2003-07-16
Foreword
This document (EN ISO 15197:2003) has been prepared by Technical Committee ISO/TC 212
"Clinical laboratory testing and in vitro test systems" in collaboration with Technical Committee
CEN/TC 140 "In vitro diagnostic medical devices", the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by November 2003, and conflicting national
standards shall be withdrawn at the latest by November 2003.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).
For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 15197:2003 has been approved by CEN as EN ISO 15197:2003 without any
modifications.
NOTE: Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 376 1999 Metallic materials - Calibration of force-proving EN ISO 376 2002
instruments used for the verification of uniaxial
testing machines
ISO 13485 1996 Quality systems - Medical devices - Particular EN ISO 13485 2000
requirements for the application of EN ISO 9001
ISO 14971 2000 Medical devices - Application of risk management EN ISO 14971 2000
to medical devices
Annex ZB
(informative)
Clauses of this European Standard addressing essential
requirements or other provisions of EU Directives
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of
the Directive 98/79/EC.
WARNING  Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
The following clauses of this standard, as detailed in Table ZB.1, are likely to support
requirements of the EU Directive 98/79/EC.
Compliance with these clauses of this standard provides one means of conforming with the
specific essential requirements of the Directive concerned and associated EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 98/79/EC
Clauses/subclauses Corresponding essential requirements of Qualifying
of this European Directive 98/79/EC remarks/Notes
Standard
4.2 A.3
4.3 B.3.3; B.3.6; B.7; B.7.1; B.7.2; B.8.7
4.4 A.1; A.2; A.4; A.5
5.1 B.8.1; B.8.2; B.8.4a, b, d, e, g, i, k; B.8.6
5.2 B.7; B.7.1; B.7.2; B.8.1; B.8.2; B.8.6; B.8.7a, e, f,
g, h, k, l, m, n, r, t, u
5.3 B.7.1; B.8.1; B.8.2; B.8.3; B.8.4a, b, d, e, g, h, i, j,
k; B.8.6
5.4 B.7; B.7.1; B.7.2; B.8.1; B.8.2; B.8.3; B.8.6;
B.8.7a, b, c, d, e, f, g, h, k, l, m, t, u
6.2 B.3.3; B.6.3; B.6.4.4
6.3 B.3.3; B.6.4.1
6.6 B.6.4.1
6.7 B.3.3
6.8 B.3.3
6.8 B.3.3
6.10 B.3.4; B.6.4.1
6.12 B.3.3; B.6.4.1
7 A.3; B.4.1; B.6.1
8.1 B.7; B.7.1
8.2 B.7; B.7.1
8.3 B.7; B.7.1; B.7.2
8.4 B.7; B.7.1; B.8.7t
INTERNATIONAL ISO
STANDARD 15197
First edition
2003-05-01
In vitro diagnostic test systems —
Requirements for blood-glucose
monitoring systems for self-testing in
managing diabetes mellitus
Systèmes d'essais de diagnostic in vitro — Exigences relatives aux
systèmes d'autosurveillance de la glycémie destinés à la prise en
charge du diabète sucré
Reference number
ISO 15197:2003(E)
©
ISO 2003
ISO 15197:2003(E)
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ii © ISO 2003 — All rights reserved

ISO 15197:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Design and development. 6
4.1 General requirements. 6
4.2 Safety. 6
4.3 Traceability. 6
4.4 Ergonomic/human factor aspects. 6
4.5 Risk analysis. 7
4.6 User verification. 7
5 Information supplied by the manufacturer. 7
5.1 Labels for the blood-glucose meter . 7
5.2 Instructions for use for the blood-glucose monitoring system . 8
5.3 Labels for the reagent system and control material . 9
5.4 Instructions for use for reagents and control material . 10
6 Safety and reliability testing . 11
6.1 General requirements. 11
6.2 Protection against electric shock. 11
6.3 Protection against mechanical hazards . 11
6.4 Electromagnetic compatibility. 11
6.5 Resistance to heat . 11
6.6 Resistance to moisture and liquids . 11
6.7 Protection against liberated gases, explosion and implosion. 12
6.8 Meter components. 12
6.9 Performance test. 12
6.10 Mechanical resistance to shock, vibration and impact. 12
6.11 Equipment temperature exposure limits . 13
6.12 Equipment humidity exposure test protocol. 13
6.13 Reagent storage and use testing . 13
7 Analytical performance evaluation . 14
7.1 General requirements. 14
7.2 Precision evaluation. 14
7.3 System accuracy evaluation. 18
7.4 Minimum acceptable system accuracy. 23
8 User performance evaluation. 25
8.1 General. 25
8.2 Evaluation sites. 25
8.3 User evaluation. 25
8.4 Evaluation of instructions for use. 26
Annex A (normative) Additional requirements for electromagnetic compatibility. 27
Annex B (informative) Traceability chain . 29
Bibliography . 31

ISO 15197:2003(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 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 15197 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro
diagnostic test systems.
iv © ISO 2003 — All rights reserved

ISO 15197:2003(E)
Introduction
Blood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals
affected by diabetes mellitus. Diabetes mellitus is caused by a relative or absolute deficiency in insulin
secretion or by insulin resistance leading to abnormal concentrations of glucose in the blood, which may result
in acute and chronic health complications. When used properly, a glucose monitoring system allows the user
to monitor and take action to control the concentration of glucose present in the blood.
This International Standard is intended for blood-glucose monitoring systems used by laypersons. The primary
objectives are to establish requirements that result in acceptable performance and to specify procedures for
demonstrating conformance to this International Standard.
Performance criteria for blood-glucose monitoring systems were established from the accuracy (precision and
trueness) required for individual glucose results. System accuracy criteria, also known in the in vitro
[35]
diagnostics (IVD) industry as total error criteria (see NCCLS EP21-P ), are used in this International
Standard because some of the metrological terms commonly used in International Standards (e.g.
uncertainty) would not be familiar to lay users. System accuracy, which is affected by systematic bias and
measurement uncertainty, describes the degree to which the individual results produced by a glucose
monitoring system agree with the true glucose values when the system is used as intended by laypersons.
The criteria for system accuracy are based on three considerations (see References [2] to [21] in the
Bibliography):
a) the effectiveness of current technology for monitoring patients with diabetes mellitus, as demonstrated in
clinical outcome studies using state-of-the-art monitoring devices;
b) recommendations of diabetes researchers as well as existing product standards and regulatory
guidelines;
c) the state-of-the-art of currently available technology, as evidenced by the performance of existing
commercial products.
In arriving at the performance criteria, desirable goals had to be weighed against the capabilities of existing
devices (the current state-of-the-art) and their effectiveness in clinical outcome studies. It was decided that
overly demanding performance requirements would cause manufacturers to focus design improvements on
analytical performance at the expense of other important attributes. For example, frequency of testing by
diabetic patients can be as important as the accuracy of an individual result, and greater convenience of
glucose self-testing improves patient compliance. The system accuracy criteria define the minimum
acceptable performance of a blood-glucose measuring device intended for self-monitoring.
Future advances in technology are expected, which should result in improved performance of glucose
monitoring devices. Such performance improvements will be driven by the competitive marketplace,
particularly through reduction of dependence on user technique.
Requirements that are unique to self-monitoring devices for blood-glucose, including the content of
information supplied by the manufacturer, are addressed in this International Standard. General requirements
that apply to all in vitro diagnostic medical devices and are covered by other standards [e.g. ISO 13485 and
ISO 14971] are incorporated by reference where appropriate.
Although this International Standard does not apply to measurement procedures with results on an ordinal
scale (e.g. visual, semiquantitative measurement procedures), it may be useful as a guide for developing
procedures to evaluate the performance of such systems.

INTERNATIONAL STANDARD ISO 15197:2003(E)

In vitro diagnostic test systems — Requirements for blood-
glucose monitoring systems for self-testing in managing
diabetes mellitus
1 Scope
This International Standard specifies requirements for in vitro glucose monitoring systems that measure
glucose concentrations in capillary blood samples and procedures for the verification and the validation of
performance by the intended users. These systems are intended for self-testing by laypersons for
management of diabetes mellitus.
This International Standard is applicable to manufacturers of such systems and those other organizations
(e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the
performance of these systems.
This International Standard does not
 provide a comprehensive evaluation of all possible factors that could affect the performance of these
systems,
 pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,
 address the medical aspects of diabetes mellitus management, or
 apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test
methods).
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 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971, Medical devices — Application of risk management to medical devices
1)
ISO 17511:— , In vitro diagnostic medical devices — Measurement of quantities in biological samples —
Metrological traceability of values assigned to calibrators and control materials
IEC 60068-2-64:1993, Environmental testing — Part 2: Test methods — Test Fh: Vibration, broad-band
random (digital control) and guidance
IEC 61010-1:2001, Safety requirements for electrical equipment for measurement, control, and laboratory
use — Part 1: General requirements
IEC 61010-2-101:2002, Safety requirements for electrical equipment for measurement, control and laboratory
use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

1) To be published.
ISO 15197:2003(E)
IEC 61000-4-2, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement techniques —
Electrostatic discharge immunity test
IEC 61000-4-3, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement techniques —
Radiated, radio-frequency, electromagnetic field immunity test
IEC 61326, Electrical equipment for measurement, control and laboratory use — EMC requirements
EN 376, Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
EN 13612, Performance evaluation of in vitro diagnostic medical devices
EN 13640, Stability testing of in vitro diagnostic reagents
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accuracy
closeness of agreement between a test result and the accepted reference value
[ISO 3534-1:1993]
NOTE 1 The term “accuracy”, when applied to a set of test results, involves a combination of random error components
and a common systematic error or bias component. [VIM:1993]
NOTE 2 For a measure of the accuracy of results of a blood-glucose monitoring system, see 3.24.
3.2
bias
difference between the expectation of the test results and an accepted reference value
[ISO 5725-1:1994]
3.3
blood-glucose monitoring system
measuring system consisting of a portable instrument and reagents used for the in vitro monitoring of glucose
concentrations in blood
NOTE Blood-glucose monitoring systems measure glucose in capillary blood samples, but may express results as
either the glucose concentration in blood or the equivalent glucose concentration in plasma. Concentrations in this
International Standard refer to the type of results reported by the system.
3.4
blood-glucose meter
component of a blood-glucose monitoring system that converts the result of a chemical reaction into the
glucose concentration of the sample
3.5
commutability of a material
ability of a material to yield the same numerical relationships between results of measurements by a given set
of measurement procedures, purporting to measure the same quantity, as those between the expectations of
the relationships obtained when the same procedures are applied to other relevant types of material
[ISO 15194:2002]
NOTE For reference materials used to calibrate measurement procedures intended for biological samples, “other
relevant types of material” include a large number of samples from healthy and relevantly diseased individuals.
2 © ISO 2003 — All rights reserved

ISO 15197:2003(E)
3.6
control material
substance, material, or article intended by the manufacturer to be used to verify the performance
characteristics of an in vitro diagnostic medical device
[EN 375:2001]
3.7
information supplied by the manufacturer with the medical device
all written, printed, or graphic matter on a medical device or any of its containers or wrappers, or
accompanying a medical device, relating to the identification, technical description and use of the medical
device, but excluding shipping documentation and promotional material
NOTE 1 Adapted from EN 1041:1998.
NOTE 2 In some countries, information supplied by the manufacturer is called “labelling”.
3.8
instructions for use
information supplied by the manufacturer with an in vitro diagnostic medical device concerning the safe and
proper use of the reagent or the safe and correct operation, maintenance, and basic troubleshooting of the
instrument
NOTE 1 Adapted from EN 375:2001 and EN 591:2001.
NOTE 2 Instructions for use for in vitro diagnostic reagents for self-testing is described in EN 376.
NOTE 3 Instructions for use for in vitro diagnostic instruments for self-testing is described in EN 592.
NOTE 4 Instructions for use may take the form of package insert sheets and/or user manuals.
3.9
intermediate precision
precision under conditions intermediate between reproducibility conditions and repeatability conditions
NOTE The concept of intermediate levels of precision is described in ISO 5725-3:1994.
3.10
intermediate precision conditions
conditions where independent test results are obtained with the same method on identical test items in the
same location, but where other variables such as operators, equipment, calibration, environmental conditions
and/or time intervals differ
NOTE Intended to measure precision in conditions leading to variability representative of actual use. Quantitative
measures of intermediate precision depend on the stipulated conditions.
3.11
label
printed, written, or graphic information placed on a device or container
NOTE Adapted from EN 375:2001.
3.12
layperson
individual who does not have formal training in a specific field or discipline
NOTE 1 Adapted from the definition of “lay user” in EN 376:2002.
NOTE 2 For the purposes of this International Standard, a user of a blood-glucose monitoring device who does not
have specific medical, scientific or technical knowledge related to blood-glucose monitoring.
ISO 15197:2003(E)
3.13
lot
batch
one or more components or finished devices that consist of a single type, model, class, size, composition, or
software version that are manufactured under essentially the same conditions and that are intended to have
uniform characteristics and quality within specified limits
[37]
NOTE In Directive 98/79/EC and in European Standards the term “batch” is preferred.
3.14
manufacturer's selected measurement procedure
measurement procedure that is calibrated by one or more primary or secondary calibrators and validated for
its intended use
NOTE ISO 17511:—, 4.2.2 f), shows the manufacturer's selected measurement procedure in the traceability chain.
3.15
manufacturer's standing measurement procedure
measurement procedure that is calibrated by one or more of the manufacturer’s working calibrators or higher
types of calibrator and validated for its intended use
NOTE ISO 17511:—, 4.2.2 h) shows the manufacturer's standing measurement procedure in the traceability chain.
3.16
package insert
instructions for use and other information for the reagent system or control material that is supplied within the
package, but not attached to any part of the package
3.17
packed cell volume
volume fraction of the erythrocytes in blood
NOTE 1 Expressed either as a decimal fraction (SI) or as a percentage (conventional). SI units (L/L) are implied.
NOTE 2 Sometimes referred to as “haematocrit” after the instrument originally used to estimate packed cell volume.
3.18
precision of measurement
closeness of agreement between independent test results obtained under stipulated conditions
[ISO 3534-1:1993]
NOTE 1 The degree of precision is expressed numerically by the statistical measures of imprecision of measurements,
such as standard deviation and coefficient of variation, that are inversely related to precision. Quantitative measures of
precision depend on the stipulated conditions.
NOTE 2 Precision of a given measurement procedure is subdivided according to the specified precision conditions.
Particular sets of extreme conditions are termed “repeatability” (3.20) and “reproducibility” (3.22).
3.19
reagent system
part of the in vitro diagnostic medical device that produces a signal via a chemical or electrochemical reaction,
which allows the analyte (e.g. glucose) in a sample to be detected and its concentration measured
3.20
repeatability
precision under repeatability conditions
[ISO 3534-1:1993]
4 © ISO 2003 — All rights reserved

ISO 15197:2003(E)
3.21
repeatability conditions
conditions where independent test results are obtained with the same method on identical test items in the
same laboratory by the same operator using the same equipment within short intervals of time
[ISO 3534-1:1993]
NOTE 1 Essentially unchanged conditions, intended to represent conditions resulting in minimum variability of test
results.
NOTE 2 For the purposes of this International Standard, “laboratories” should be interpreted as “locations.”
3.22
reproducibility
precision under reproducibility conditions
[ISO 3534-1:1993]
3.23
reproducibility conditions
conditions where test results are obtained with the same method on identical test items in different
laboratories with different operators using different equipment
[ISO 3534-1:1993]
NOTE 1 Completely changed conditions, intended to represent conditions resulting in maximum variability of test
results.
NOTE 2 For the purposes of this International Standard, “laboratories” should be interpreted as “locations”.
3.24
system accuracy
closeness of agreement of a set of representative test results from a measuring system and their respective
reference values
NOTE 1 The term accuracy, when applied to a set of test results, involves a combination of random error components
and a common systematic error or bias component. [VIM:1993]
NOTE 2 Reference values are assigned by a measurement procedure traceable to a reference measurement
procedure of higher order.
NOTE 3 System accuracy may be expressed as the interval that encompasses 95 % of the differences observed
between the results of the system being evaluated and their reference values. This interval also includes measurement
uncertainty from the measurement procedure used to assign the reference values.
3.25
traceability
property of the result of a measurement or the value of a standard whereby it can be related to stated
references, usually national or international standards, through an unbroken chain of comparisons all having
stated uncertainties
[VIM:1993, 6.10]
3.26
trueness
closeness of agreement between the average value obtained from a large series of test results and an
accepted reference value
[ISO 3534-1:1993]
NOTE The measure of trueness is usually expressed in terms of bias (3.2).
ISO 15197:2003(E)
3.27
type test
test of one or more samples of equipment (or parts of equipment) made to a particular design, to show that
the design and construction meet one or more requirements of the applicable standard
NOTE 1 Statistical sampling is not required for blood-glucose monitoring equipment.
NOTE 2 Adapted from IEC 61326.
3.28
user adjustment of blood-glucose monitoring system
procedure described in the instructions for use in which the user enters a number, inserts a code strip or chip,
etc., so that the system achieves acceptable performance characteristics
4 Design and development
4.1 General requirements
The requirements specified in ISO 13485 apply.
NOTE Clause 6, 7.2 and 7.3 describe design verification activities, which are intended to provide assurance that the
system has the capability of meeting its precision, trueness, safety, and reliability specifications. Clause 8 describes
design validation activities, which are intended to provide assurance that system accuracy meets user requirements.
4.2 Safety
The requirements specified in IEC 61010-1 and IEC 61010-2-101 apply.
4.3 Traceability
The requirements specified in ISO 17511 apply to the manufacturer’s calibration process.
NOTE 1 The manufacturer’s selected or standing measurement procedure may measure glucose in either blood or
plasma samples. If plasma samples are used, the blood-glucose monitoring system may report results as plasma glucose
equivalents, even though the samples measured by the blood-glucose monitoring system are blood.
NOTE 2 The traceability chain should include as few steps as practical to minimize combined uncertainty.
NOTE 3 A traceability chain for a typical factory-calibrated blood-glucose monitoring system is shown in Annex B. This
example is not intended to represent the only possibility of a suitable traceability chain.
4.4 Ergonomic/human factor aspects
The design of the blood-glucose monitoring system shall take into consideration ergonomic and relevant
human factors for the following:
a) ease of operation;
b) ease of maintenance;
c) protection from “wear and tear” that might typically be encountered in the use environment;
d) readability of the measured results;
e) unambiguous messages to the user, e.g. “low battery” or “low result”, rather than simply “low”.
NOTE 1 Blood-glucose monitoring systems intended for self-measurement may be used by laypersons with different
physical and mental abilities.
6 © ISO 2003 — All rights reserved

ISO 15197:2003(E)
NOTE 2 These systems are often transported by the individual users, who may conduct measurements in a variety of
settings.
NOTE 3 It is not expected that a single blood-glucose monitoring system will meet the needs of all possible users or
settings.
4.5 Risk analysis
The requirements specified in ISO 14971 apply.
The manufacturer shall decide the acceptability of potential risks from knowledge of factors including but not
limited to
a) intended use of the product,
b) users’ skills and limitations,
c) protection against unintentional change of essential parameters (e.g. units reported), or
d) influence of interfering substances.
[31]
NOTE Guidelines for evaluating potentially interfering substances are found in NCCLS EP7-A .
In performing risk analysis, the manufacturer shall evaluate the
e) probability of occurrence of a failure (e.g. insufficient sample volume or incorrect test strip placement),
f) probability of the system not detecting a failure, and
g) consequences of an undetected failure.
NOTE This International Standard does not specify levels of risk and acceptability.
4.6 User verification
The design of the blood-glucose monitoring system shall allow the user to check:
a) correct functioning of the blood-glucose monitoring system, (i.e. system control); and
b) correct execution of the test including the sequence of the procedural steps.
NOTE User verification should be done at the time of use. “At the time of use” means before, during, or immediately
after the execution of the test. User verification should be integrated into the test if reasonably possible.
User verification shall give unambiguous information.
5 Information supplied by the manufacturer
5.1 Labels for the blood-glucose meter
The blood-glucose meter shall be identified by labels including, at a minimum, the following information:
a) name or trade name of the manufacturer and address of the manufacturer;
b) product name or designation (this information shall directly appear on a label affixed to the device);
c) intended purpose (a statement that the device is an in vitro diagnostic medical device for self-testing shall
be included, as well as information regarding the reagent system to be used with the device);
ISO 15197:2003(E)
d) lot or serial number appearing directly on a label affixed to the device;
e) conditions for storage and handling, if appropriate;
f) a reference to the user manual or instructions for use.
Where appropriate, information on the label should take the form of symbols. Symbols shall conform to
applicable regulations and International Standards. All symbols shall be described in the information supplied
with the blood-glucose meter.
5.2 Instructions for use for the blood-glucose monitoring system
The instructions for use shall be presented in a clear and concise manner, using plain terminology that is
readily understood by a layperson. The information shall be well organized and easy to read. The print shall
be large (e.g. 12-point Courier) and the content shall be readily understandable by persons without a scientific
or technical background. Symbols and illustrations shall be used where appropriate.
The instructions for use shall clearly state what actions to take if the verification indicates an invalid result.
The language(s) of the country in which the blood-glucose monitoring system is distributed shall be used.
Additional languages are optional.
The instructions for use shall include the following information:
a) name or trade name and address of the manufacturer, the name and address of the distributor (if
[37]
applicable) (in the European Union, Directive 98/79/EC requires the name and address of the
“authorized representative” if the manufacturer is not located in the European Union), and how to access
help;
b) product name or designation;
c) intended purpose of the device;
d) the principle of the method;
e) measurement procedures and/or calibrator materials (traceability to a reference measurement procedure
and/or reference material of higher order should be indicated, if applicable) used by the manufacturer to
establish and evaluate performance characteristics;
f) the type of samples used by the manufacturer for calibration, e.g. blood or plasma;
g) proper reagent system to be used;
h) measurement procedure to be followed when using the device, including:
 the sequence of adjustment (e.g. use of a number, code strip, code chip, etc.), measurement and
verification, and the allocated time intervals between them;
 the sequence of steps to prepare the instrument for the measurement, to execute the measurement
(including the amount and recommended appearance of the sample) and to maintain the instrument
after the measurement;
 the measurement units reported by the device, e.g. mmol/L or mg/dL;
 whether reported results are equivalent to blood or plasma results;
 advice on how to proceed when an error message is generated by the meter;
i) environmental conditions (e.g. temperature and humidity range) under which the system shall be used;
8 © ISO 2003 — All rights reserved

ISO 15197:2003(E)
j) detailed procedure to be followed by the user in adjusting the device, if applicable;
k) detailed user control procedures, including identification of the appropriate control material to be used to
assure that the blood-glucose monitoring system is operating properly and advice on how to proceed if
control results are not acceptable;
l) type of sample to be used, as well as any special conditions of collection and pretreatment;
m) precautions to be taken against the risk of infection from prior use of the instrument;
n) precautions to be taken regarding electrostatic discharge, magnetic fields, and other electrical conditions,
as well as exposure to temperature, humidity, and other environmental conditions, as applicable (see
IEC 61010-2-101:2002, Clause 5);
o) description and explanation of all symbols used on labels and in the instructions for use;
p) guidance on action to be taken by the user as a consequence of the result, including:
 a reference to the instructions given by a physician and/or other qualified healthcare provider, and a
warning not to deviate from these instructions on the basis of the result without first consulting the
physician or other qualified healthcare provider;
 advice on how to proceed if the result appears to be questionable to the user;
 indication how the monitoring system alerts the user when the result is outside the “measurement
interval” (e.g. error messages, fault notifications);
q) information on the safe disposal of the system and its components, where appropriate;
r) the year and month of issue of the instructions for use and/or the revision number.
5.3 Labels for the reagent system and control material
The reagent system and control material shall be identified by a label or labels.
The requirements specified in EN 376 apply.
In addition, the following information shall be included on the label(s):
a) indication of the period of time during which the reagent should be used after the first opening of the
immediate reagent container, expressed as months and/or days;
b) a reference to the instructions for use;
c) the blood-glucose meter to be used with the reagents.
Warning statements concerning use of the reagent system with the specified blood-glucose meter and
disposal of the reagent system after use should be included on the label to promote reliable measurement
results and safe reagent disposal.
The language(s) of the country in which the reagents and control materials are distributed shall be used;
additional languages are optional.
ISO 15197:2003(E)
5.4 Instructions for use for reagents and control material
The requirements specified in EN 376 apply.
In addition, the following information shall be included:
a) an indication of how to access help from the manufacturer and/or distributor;
b) the specific blood-glucose meter to be used with the reagent system and control material;
c) the stor
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