BS EN ISO 15197:2015 - TC - Tracked Changes. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

BS EN ISO 15197:2015 - TC

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

Status : Under review, Current   Published : February 2020

Format
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Standard NumberBS EN ISO 15197:2015 - TC
TitleTracked Changes. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
StatusUnder review, Current
Publication Date25 February 2020
Normative References(Required to achieve compliance to this standard)EN ISO 17511:2003, IEC 60068-2-64, IEC 61326-1, ISO 18113-1, IEC 61326-2-6, ISO 13485, IEC 61010-2-101, ISO 18113-4, IEC 62366, ISO 23640, ISO 18113-5, EN 13612, IEC 61010-1, EN ISO 23640:2014, ISO 14971, EN ISO 14971:2012, EN ISO 18113-4:2011, EN ISO 18113-5:2011, EN 61010-1:2010, EN 13612:2002, EN ISO 13485:2012, ISO 17511:2020, BS EN ISO 17511:2020, EN 62366:2008, EN 60068-2-64:2008, EN 61326-1:2013, EN 61326-2-6:2013, EN 61010-2-101:2002, EN ISO 18113-1:2011
Informative References(Provided for Information)ISO 5725-2, ISO 5725-1, ISO 5725-3, 98/79/EC, ISO/IEC Guide 99:2007
DescriptorsMeasurement, Blood, Glucose, Clinical investigation instruments
ICS11.040.55
11.100.10
CommitteeCH/212
ISBN978 0 539 09157 1
PublisherBSI
FormatA4
DeliveryYes
Pages131
File Size4.277 MB
Price£364.00


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