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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.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

BS ISO 5725-3:1994
Действует
Accuracy (trueness and precision) of measurement methods and results. Intermediate measures of the precision of a standard measurement method — 38 стр.
BS ISO 5725-2:1994
Действует
Accuracy (trueness and precision) of measurement methods and results. Basic methods for the determination of repeatability and reproducibility of a standard measurement method — 62 стр.
BS ISO 5725-1:1994
Действует
Accuracy (trueness and precision) of measurement methods and results. General principles and definitions — 26 стр.
ISO/IEC Guide 99:2007
Действует
International vocabulary of metrology -- Basic and general concepts and associated terms (VIM) — 108 стр.
BS EN 13612:2002
Действует
Performance evaluation of in vitro diagnostic medical devices — 18 стр.
BS EN 62366:2008
Заменен
Medical devices. Application of usability engineering to medical devices — 104 стр.
BS EN 61326-2-6:2013
Действует
Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment — 14 стр.
BS EN 61326-1:2013
Действует
Electrical equipment for measurement, control and laboratory use. EMC requirements. General requirements — 24 стр.
BS EN 61010-2-101:2002
Заменен
Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment — 26 стр.
BS EN 61010-1:2010
Действует
Safety requirements for electrical equipment for measurement, control, and laboratory use. General requirements — 162 стр.
BS EN 60068-2-64:2008
Действует
Environmental testing. Tests. Test Fh. Vibration, broadband random and guidance — 36 стр.
BS EN ISO 18113-5:2011
Действует
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing — 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 18113-1:2011
Действует
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements — 62 стр.
BS EN ISO 17511:2003
Действует
In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials — 32 стр.
BS EN ISO 14971:2012
Действует
Medical devices. Application of risk management to medical devices — 104 стр.
BS EN ISO 13485:2012
Заменен
Medical devices. Quality management systems. Requirements for regulatory purposes — 86 стр.
IEC 62366:2007 ed1.0
Заменен
Medical devices - Application of usability engineering to medical devices — 209 стр.
IEC 61326-2-6:2005/COR1:2007 ed1.0
Заменен
Corrigendum 1 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment — 0 стр.
IEC 61326-1:1997 ed.0
Заменен
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements — 31 стр.
IEC 61010-2-101:2002 ed1.0
Заменен
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment — 43 стр.
IEC 61010-1:2010 ed3.0
Действует
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements — 322 стр.
IEC 60068-2-64:1993/COR1:1993 ed1.0
Заменен
Corrigendum 1 - Environmental testing - Part 2: Test methods - Test Fh: Vibration, broad-band random (digital control) and guidance — 1 стр.
ISO 23640:2011
Действует
In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents — 12 стр.
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.
ISO 18113-4:2009
Действует
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing — 18 стр.
ISO 18113-1:2009
Действует
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements — 56 стр.
ISO 17511:2003
Действует
In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials — 31 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
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.

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