EN ISO 15197:2013
(Main)In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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 the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 15197:2013 has been approved by CEN as EN ISO 15197:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC in vitro diagnostic medical
devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 98/79/EC in vitro diagnostic medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 98/79/EC in vitro
diagnostic medical devices
Essential requirements
Clauses of this international
(ERs) of Qualifying Comments/Notes
Standard
Directive 98/79/EC
4.2, 6 A.3
4.3, 4.4 A.4 Aspects related to mechanical stress are
not covered
4.3, 4.4, 6.5, 7 A.5 Packaging aspects are not covered.
4.3, 5.2, 5.3, 5.4, 5.5, 5.6, 5.8, 5.10, B.3.3
5.11, 5.12
5.7 B.3.4
4.4 B.3.6
6, 7 B.4.1
6 B.6.1
5.2 B.6.3
5.3, 5.6 B.6.4.1 “Life time resistance to mechanical stress”
is not covered.
5.2 B.6.4.4 Clause 5.2 only partially covers this ER,
as it deals only with electrical terminals
and connectors.
4.4, 7, 8 B.7.1
7 B.8.1 The sixth paragraph of this ER
(translation into other languages) is not
covered.
7 B.8.2 Covered by reference to EN ISO 18113-1.
7 B.8.3 This aspect is covered by normative
reference to EN ISO 18113-4 and
EN ISO 18113-5. However, essential
requirement B.8.3 of Directive 98/79/EC
should be consulted for a comprehensive
list of the information required
7 B.8.4 Not all the requirements of ER B.8.4 are
covered, but only those required by
EN ISO 18113-1, EN ISO 18113-4 and
EN ISO 18113-5, related to IVD medical
devices for self – testing
7 B.8.4(a) If the manufacturer is not located in the
EU, the manufacturer is required to
designate an “EC Authorised
Representative” established in the EU. In
such cases and to comply with this ER,
the name and address of the Authorised
Representative are required
7 B.8.4(d) Full compliance with this ER requires the
use of the symbol [LOT] and the symbol
[SN], as applicable.
7 B.8.6 Covered by normative reference to
EN ISO 18113-4 and EN ISO 18113-5.
4.2, 7 B.8.7 Not all the requirements of this ER are
covered, but only those required by the
labelling standards EN ISO 18113-1,
EN ISO 18113-4 and EN ISO 18113-5,
related to IVD medical devices for self –
testing
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 15197
Second edition
2013-05-15
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 15197:2013(E)
©
ISO 2013
ISO 15197:2013(E)
© ISO 2013
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ii © ISO 2013 – All rights reserved
ISO 15197:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Design and development . 8
4.1 General requirements . 8
4.2 Metrological traceability . 8
4.3 Safety and risk management . 9
4.4 Ergonomics and human factors .10
4.5 User verification requirements .10
5 Safety and reliability testing .10
5.1 General requirements .10
5.2 Protection against electric shock .11
5.3 Protection against mechanical hazards .11
5.4 Electromagnetic compatibility .11
5.5 Resistance to heat .11
5.6 Resistance to moisture and liquids .11
5.7 Protection against liberated gases, explosion and implosion.12
5.8 Meter components .12
5.9 Performance test .12
5.10 Mechanical resistance to vibration and shock .12
5.11 Equipment temperature exposure limits for storage .13
5.12 Equipment humidity exposure limits for storage .13
6 Analytical performance evaluation .14
6.1 General requirements .
...
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