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)

2012-10-30 GVN: // vote draft provided to ISO/CS according to notification received in dataservice on 2012-10-29
2011-08-24 EMA: DOW = DAV + 36 months (see confirmation from PM sent to dataservice on 2011-08-24).
2010-11-17 EMA: // ENQ draft provided to ISO/CS according to notification received in dataservice on 2010-11-12.

Testsysteme für die In­vitro­Diagnostik - Anforderungen an Blutzuckermesssysteme zur Eigenanwendung bei Diabetes mellitus (ISO 15197:2013)

Die vorliegende Internationale Norm legt Anforderungen an In vitro Glukosemesssysteme zur Messung von Glukosekonzent¬rationen in Kapillarblutproben für spezifische Design-Verifizierungsverfahren und zur Validierung der Leistungsfähigkeit durch die vorgesehenen Anwender fest. Diese Systeme sind für die Selbstmessung durch Laien zur Führung des Diabetes mellitus vorgesehen.
Diese Internationale Norm gilt für die Hersteller derartiger Systeme und für diejenigen sonstigen Organisationen (z. B. Zulassungsbehörden und Institutionen zur Konformitätsbeurteilung), die für die Beurteilung der Leistungsfähigkeit dieser Systeme verantwortlich sind.
Diese Internationale Norm
-   liefert keine umfassende Bewertung aller möglichen Faktoren, die die Leistungsfähigkeit dieser Systeme beeinflussen können;
-   gilt nicht für die Glukosekonzentrationsmessung zur Diagnose des Diabetes mellitus;
-   behandelt nicht die medizinischen Aspekte der Führung des Diabetes mellitus;
-   gilt nicht für Messverfahren, bei denen die Messwerte auf einer Ordinalskale dargestellt werden (z. B. visuelle, halbquantitative Messverfahren) oder für kontinuierliche Glukosemesssysteme;
-   gilt nicht für Blutzuckermessgeräte in medizinischen Applikationen, die nicht für den Gebrauch der Selbstüberwachung zum Management von Diabetes mellitus gedacht sind.

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 15197:2013)

Diagnostični preskusni sistemi in vitro - Zahteve za sisteme nadzora glukoze v krvi za samopreskušanje pri obravnavi sladkorne bolezni (ISO 15197:2013)

Ta mednarodni standard določa zahteve za sisteme nadzora glukoze v krvi in vitro, ki merijo koncentracije glukoze v vzorcih kapilarne krvi, za posebne postopke overjanja modelov in za preverjanje delovanja s strani predvidenih uporabnikov. Ti sistemi so namenjeni za samopreskušanje pri obravnavi sladkorne bolezni, torej za laično uporabo. Ta mednarodni standard velja za proizvajalce takšnih sistemov in druge organizacije (npr. regulativni organi in organi za ugotavljanje skladnosti), odgovorne za ocenjevanje delovanja takšnih sistemov. Ta mednarodni standard: – ne zagotavlja celovitega vrednotenja morebitnih dejavnikov, ki bi lahko vplivali na delovanje teh sistemov; – ne zadeva merjenja koncentracije glukoze z namenom diagnosticiranja sladkorne bolezni; – ne obravnava zdravstvenih vidikov obravnave sladkorne bolezni; – ne velja za postopke merjenja z izmerjenimi vrednostmi po razvrstitveni lestvici (npr. vizualni polkvantitativni postopki merjenja) ali za sisteme neprekinjenega nadzora glukoze; – ne velja za merilnike glukoze, ki so namenjeni za uporabo v medicini za nadzor sladkorne bolezni, ki ga ne izvaja oboleli sam.

General Information

• Status: Withdrawn
• Publication Date: 21-May-2013
• Withdrawal Date: 09-Jun-2015
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.100.10 - In vitro diagnostic test systems
• 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
• Completion Date: 10-Jun-2015
• 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 15197:2013 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

Relations

• Replaces: 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: 29-May-2013
• Replaces: 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)
• Effective Date: 15-Aug-2009
• Replaced By: EN ISO 15197:2015 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
• Effective Date: 24-Jun-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15197:2013
01-september-2013
1DGRPHãþD
SIST EN ISO 15197:2003
SIST EN ISO 15197:2003/AC:2005
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR=DKWHYH]DVLVWHPHQDG]RUDJOXNR]HYNUYL
]DVDPRSUHVNXãDQMHSULREUDYQDYLVODGNRUQHEROH]QL,62
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for
self-testing in managing diabetes mellitus (ISO 15197:2013)
Testsysteme für die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme zur
Eigenanwendung beim Diabetes mellitus (ISO 15197:2013)
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
15197:2013)
Ta slovenski standard je istoveten z: EN ISO 15197:2013
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN ISO 15197:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 15197:2013

---------------------- Page: 2 ----------------------

SIST EN ISO 15197:2013


EUROPEAN STANDARD
EN ISO 15197

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2013
ICS 11.100.10 Supersedes EN ISO 15197:2003
English Version
In vitro diagnostic test systems - Requirements for blood-
glucose monitoring systems for self-testing in managing
diabetes mellitus (ISO 15197:2013)
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 15197:2013)
15197:2013)
This European Standard was approved by CEN on 15 May 2013.

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 CEN-CENELEC 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 CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15197:2013: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 15197:2013
EN ISO 15197:2013 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC in vitro diagnostic medical devices .4

2

---------------------- Page: 4 ----------------------

SIST EN ISO 15197:2013
EN ISO 15197:2013 (E)
Foreword
This document (EN ISO 15197:2013) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with the 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 2013, and conflicting national standards shall be withdrawn
at the latest by November 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15197:2003.
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, see informative Annex ZA, which is an integral part of this document.
According to
...