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.
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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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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.
...