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PD ISO/TS 17822-1:2014

Действует
$iI$in $iv$ii$it$ir$io diagnostic test systems. Qualitative nucleic acid-based $ii$in $iv$ii$it$ir$io examination procedures for detection and identification of microbial pathogens. General requirements, terms and definitions — 32 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO 15189:2012
Действует
Medical laboratories -- Requirements for quality and competence — 58 стр.
ISO 15190:2003
Действует
Medical laboratories -- Requirements for safety — 46 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 18113-2:2009
Действует
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use — 18 стр.
ISO 18113-3:2009
Действует
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use — 16 стр.
ISO 23640:2011
Действует
In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents — 12 стр.
ISO 21569:2005
Действует
Foodstuffs -- Methods of analysis for the detection of genetically modified organisms and derived products -- Qualitative nucleic acid based methods — 76 стр.
ISO 21571:2005
Действует
Foodstuffs -- Methods of analysis for the detection of genetically modified organisms and derived products. Nucleic acid extraction — 50 стр.
ISO 21572:2013
Действует
Foodstuffs -- Molecular biomarker analysis -- Protein-based methods — 34 стр.
ISO 21748:2010
Заменен
Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation — 46 стр.
ISO 22174:2005
Действует
Microbiology of food and animal feeding stuffs -- Polymerase chain reaction (PCR) for the detection of food-borne pathogens -- General requirements and definitions — 18 стр.
ISO 24276:2006
Действует
Foodstuffs -- Methods of analysis for the detection of genetically modified organisms and derived products -- General requirements and definitions — 24 стр.
ISO 5725-1:1994
Действует
Accuracy (trueness and precision) of measurement methods and results. Part 1. General principles and definitions — 24 стр.
ISO 5725-2:1994
Действует
Accuracy (trueness and precision) of measurement methods and results. Part 2. Basic method for the determination of repeatability and reproducibility of a standard measurement method — 52 стр.
ISO 5725-3:1994
Действует
Accuracy (trueness and precision) of measurement methods and results - Part 3: Intermediate measures of the precision of a standard measurement method — 36 стр.
ISO/TR 22971:2005
Действует
Accuracy (trueness and precision) of measurement methods and results -- Practical guidance for the use of ISO 5725-2:1994 in designing, implementing and statistically analysing interlaboratory repeatability and reproducibility results — 40 стр.
ISO/TS 22367:2008
Действует
Medical laboratories -- Reduction of error through risk management and continual improvement — 18 стр.

На этот документ ссылаются

DIN EN ISO 20166-1:2019-04
Действует
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018); German version EN ISO 20166-1:2018 — 33 стр.