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

BS EN ISO 15197:2003

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

Status : Revised, Superseded, Withdrawn   Published : May 2003 Replaced By : BS EN ISO 15197:2013

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Standard NumberBS EN ISO 15197:2003
TitleIn vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
StatusRevised, Superseded, Withdrawn
Publication Date27 May 2003
Withdrawn Date30 June 2013
Normative References(Required to achieve compliance to this standard)ISO 13485, ISO 13485:1996, ISO 14971, ISO 14971:2000, EN ISO 13485:2000, EN ISO 14971:2000, ISO 17511, IEC 60068-2-64:1993, IEC 61010-1:2001, IEC 61010-2-101:2002, IEC 61000-4-2, IEC 61000-4-3, IEC 61326, EN 376, EN 13612, EN 13640
Informative References(Provided for Information)CSA Z316.4-94, NCCLS C30-A2, TNO-CMT/90.021 E, ISO 3534-1:1993, ISO 5725-1, ISO 5725-2, ISO 5725-3, ISO 13488, ISO 14969:1999, VIM:1993, EN 375:2001, EN 592:2002, EN 13532:2002, NCCLS EP5-A, NCCLS EP7-A, NCCLS EP9-A2, NCCLS EP21-P, 98/79/EC, NCCLS EP18-P, ISO 15194:2002, EN 1041:1998, EN 591:2001
Replaced ByBS EN ISO 15197:2013
International RelationshipsEN ISO 15197:2003,ISO 15197:2003
Amended ByAMD 14616
AMD 14616 is a Corrigendum. Corrigendum, July 2011.
Draft Superseded By00/560160 DC
DescriptorsClinical investigation instruments, Glucose, Blood, Measurement
ICS11.040.55
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 GermanAnforderungen an In-vitro-Messsysteme für die Selbstüberwachung der Blutglukose zur Kontrolle des Diabetes mellitus
CommitteeCH/212
ISBN978 0 580 75203 2
PublisherBSI
FormatA4
DeliveryNo
Pages46
File Size1.312 MB
Price£246.00


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