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ISO 18113-5:2009

Действует
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing — 16 стр.
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На этот документ ссылаются

BS EN ISO 15197:2013
Заменен
In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus — 60 стр.
BS EN ISO 15223-1:2012 (CD-ROM)
Действует
Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements — 52 стр.
BS EN 61010-2-101:2017
Действует
Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment — 26 стр.
BS EN ISO 22870:2016
Действует
Point-of-care testing (POCT). Requirements for quality and competence — 22 стр.
BS EN ISO 18113-4:2011
Действует
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing — 24 стр.
BS EN ISO 15223-1:2016
Действует
Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements — 44 стр.
BS EN ISO 15197:2015
Действует
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus — 60 стр.
BS EN ISO 15223-1:2012
Заменен
Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements — 36 стр.
BS ISO 17593:2007
Действует
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy — 64 стр.
ÖNORM EN ISO 15197:2013-12
Заменен
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
ÖNORM EN ISO 15197:2015-12
Действует
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
OVE EN 61010-2-101:2017-11
Действует
Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment ( IEC 61010-2-101:2015) (english version)