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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.
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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.
PD ISO Guide 34:2009
Заменен
General requirements for the competence of reference material producers — 46 стр.
BS EN ISO 18113-2:2011
Действует
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use — 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 16140-1:2016
Действует
Microbiology of the food chain. Method validation. Vocabulary — 24 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 15194:2009
Действует
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation — 26 стр.
BS EN ISO 15193:2009
Действует
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures — 30 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.
PD ISO GUIDE 30:2015
Действует
Reference materials. Selected terms and definitions — 16 стр.
BS EN 14136:2004
Действует
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures — 14 стр.
BS EN ISO/IEC 17025:2017
Действует
General requirements for the competence of testing and calibration laboratories — 38 стр.
BS EN 15842:2010
Действует
Foodstuffs. Detection of food allergens. General considerations and validation of methods — 22 стр.
BS EN ISO 14971:2012
Действует
Medical devices. Application of risk management to medical devices — 104 стр.
BS ISO 20387:2018
Действует
Biotechnology. Biobanking. General requirements for biobanking — 44 стр.
BS EN ISO 15195:2003
Действует
Laboratory medicine. Requirements for reference measurement laboratories — 24 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 15195:2004-01
Заменен
Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
ÖNORM EN ISO 15195:2019-06
Действует
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
ÖNORM EN ISO 15194:2009-09
Действует
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
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)