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About This Item
Full Description
Cross References:
ISO 13485
ISO 14971
ISO 17511
ISO 18113-1
ISO 18113-4
ISO 18113-5
ISO 23640
IEC 60068-2-64
IEC 61010-1
IEC 61010-2-101
IEC 61326-1
IEC 61326-2-6
IEC 62366
EN 13612
ISO 3534-1:1993
ISO 5725-1
ISO 5725-2
ISO 5725-3
ISO 14969:1999
ISO 18153
EN 13532:2002
CSA Z316.4-94
All current amendments available at time of purchase are included with the purchase of this document.
Document History
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BS EN ISO 15197:2015
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus- Most Recent
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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- Historical Version
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BS EN ISO 15197:2003
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus- Historical Version
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BS 11/30208525 DC
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BS EN ISO 15197. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus- Historical Version