SIST EN ISO 15197:2003
(Main)In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
This standard specifies procedures for the determination of performance criteria for quantitative in vitro blood glucose monitoring systems for management of diabetes mellitus. The primary goal of the standard is to assure the performance of blood glucose monitoring systems for self-testing and similar applications, such as bedside testing, and to specify tests by which compliance with the requirements can be verified, if applicable.
Testsysteme für die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme zur Eigenanwendung beim Diabetes mellitus (ISO 15197:2003)
Diese Internationale Norm legt Anforderungen an quantitative In-vitro-Messsysteme zur Blutglukosekontrolle, mit denen Glukosekonzentrationen in Kapillarblutproben gemessen werden, sowie Verfahren zur Überprüfung und Validierung der Leistungsfähigkeit durch die vorgesehenen Anwender fest. Diese Systeme sind für die Selbstüberwachung von Laien zur Kontrolle des Diabetes mellitus vorgesehen.
Diese Internationale Norm gilt für die Hersteller solcher Systeme und für diejenigen sonstigen Organisationen (z. B. Zulassungsbehörden und Institutionen zur Bewertung der Normenübereinstimmung), die für die Beurteilung der Leistungsfähigkeit dieser Systeme verantwortlich sind.
Diese Internationale Norm
3 beabsichtigt nicht, eine umfassende Einschätzung aller möglichen Faktoren, die die Leistungsfähigkeit dieser Systeme beeinflussen könnten, zu liefern;
3 gilt nicht für die Blutglukosebestimmung zur Diagnose des Diabetes mellitus;
3 behandelt nicht die medizinischen Aspekte der Führung des Diabetes-mellitus bei Patienten; und
3 gilt nicht für Messverfahren, bei denen die Ergebnisse auf einer Ordinalskala dargestellt werden (z. B. visuelle, halbquantitative Prüfverfahren).
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)
L'ISO 15197:2003 spécifie les exigences relatives aux systèmes de surveillance de la glycémie in vitro dans des échantillons de sang capillaire ainsi que les méthodes permettant aux utilisateurs prévus de vérifier et de valider les performances. Ces systèmes sont destinés à l'autosurveillance du diabète sucré par les malades eux-mêmes.
L'ISO 15197:2003 est applicable aux fabricants de ces systèmes ainsi qu'aux organismes (autorités réglementaires et organismes d'évaluation de la conformité) ayant la responsabilité de l'évaluation des performances de ces systèmes.
L'ISO 15197:2003 ne fournit pas d'évaluation complète de tous les facteurs possibles susceptibles d'altérer la performance de ces systèmes, ne concerne pas la mesure de la glycémie dans un but de diagnostic du diabète sucré, ne traite pas des aspects médicaux de la prise en charge du diabète sucré, et ne s'applique pas aux méthodes de mesure dont les résultats sont lus sur une échelle ordinale (par exemple: méthodes de dosage visuelles, semi-quantitatives).
Diagnostični preskusni sistemi in vitro – Zahteve za sisteme monitoringa glukoze v krvi za samopreskušanje pri obravnavi sladkorne bolezni (ISO 15197:2003)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15197:2003
01-september-2003
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR±=DKWHYH]DVLVWHPHPRQLWRULQJDJOXNR]H
YNUYL]DVDPRSUHVNXãDQMHSULREUDYQDYLVODGNRUQHEROH]QL ,62
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
SIST EN ISO 15197:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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.
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EN ISO 15197:2003 (E)
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).
2
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EN ISO 15197:2003 (E)
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
3
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EN ISO 15197:2003 (E)
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
4
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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
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ISO 15197:2003(E)
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ii © ISO 2003 — All rights reserved
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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 2003 — All rights reserved iii
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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
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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.
© ISO 2003 — All rights reserved v
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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 2003 — All rights reserved 1
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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
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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 2003 — All rights reserved 3
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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 measuremen
...
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