BS EN ISO 15197:2013 - In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus
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BS EN ISO 15197:2013

In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus

Status : Revised, Withdrawn   Published : June 2013 Replaced By : BS EN ISO 15197:2015

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Standard NumberBS EN ISO 15197:2013
TitleIn vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus
StatusRevised, Withdrawn
Publication Date30 June 2013
Confirm Date24 October 2018
Withdrawn Date30 June 2015
Normative References(Required to achieve compliance to this standard)IEC 62366, IEC 61326-2-6, EN 13612, ISO 14971, IEC 61010-2-101, IEC 61326-1, IEC 60068-2-64, ISO 18113-4, ISO 23640, ISO 18113-5, ISO 18113-1, IEC 61010-1, ISO 17511, ISO 13485
Informative References(Provided for Information)98/79/EC, ISO 5725-3, ISO 5725-1, ISO 5725-2:2019, ISO/IEC Guide 99:2007, BS ISO 5725-2:2019
Replaced ByBS EN ISO 15197:2015
International RelationshipsISO 15197:2013,EN ISO 15197:2013
Draft Superseded By11/30208525 DC
DescriptorsBlood, Clinical investigation instruments, Measurement, Glucose
ICS11.040.55
11.100.10
Title in FrenchSystèmes d'essais de diagnostic in vitro. Exigences relatives aux systèmes d'autosurveillance de la glycémie destinés à la prise en charge du diabète sucré
Title in GermanTestsysteme für die In-vitro-Diagnostik. Anforderungen an Blutzuckermesssysteme zur Eigenanwendung beim Diabetes mellitus
CommitteeCH/212
ISBN978 0 580 68839 3
PublisherBSI
FormatA4
DeliveryNo
Pages60
File Size2.091 MB
Price£260.00


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