EN ISO 15197:2003

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

ISO 15197:2003 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.
ISO 15197:2003 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.
ISO 15197:2003 does not provide a comprehensive evaluation of all possible factors that could affect the performance of these systems; does not pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus; does not address the medical aspects of diabetes mellitus management; does not apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).

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
¾ beabsichtigt nicht, eine umfassende Einschätzung aller möglichen Faktoren, die die Leistungsfähigkeit dieser Systeme beeinflussen könnten, zu liefern;
¾ gilt nicht für die Blutglukosebestimmung zur Diagnose des Diabetes mellitus;
¾ behandelt nicht die medizinischen Aspekte der Führung des Diabetes-mellitus bei Patienten; und
¾ gilt nicht für Messverfahren, bei denen die Ergebnisse auf einer Ordinalskala dargestellt werden (z. B. visuelle, halbquantitative Prüfverfahren).

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 (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

• Status: Withdrawn
• Publication Date: 30-Apr-2003
• Withdrawal Date: 21-May-2013
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 8 - IVDs for self-testing
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 22-May-2013
• Completion Date: 22-May-2013
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: SIST EN ISO 15197:2003 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

Relations

• Replaced By: EN ISO 15197:2013 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
• Effective Date: 15-Aug-2009
• Corrected By: EN ISO 15197:2003/AC:2005 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
• Effective Date: 08-Jun-2022

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
...