ISO 22174:2005
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Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens General requirements and definitions
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ISO 21572:2013
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Foodstuffs Molecular biomarker analysis Protein-based methods
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ISO 5725-1:1994
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Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
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ISO 18113-1:2009
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
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CLSI EP23 A : 1ED 2011
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LABORATORY QUALITY CONTROL BASED ON RISK MANAGEMENT
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CLSI EP17 A2 : 2ED 2012
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EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
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ISO 15189:2012
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Medical laboratories — Requirements for quality and competence
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CLSI EP5 A2 : 2ED 2004
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EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
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ISO/TR 22971:2005
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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
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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ISO 24276:2006
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Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions
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CLSI EP12 A2 : 2ED 2008
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USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
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ISO 5725-3:1994
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Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
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CLSI EP24 A2 : 2ED 2011
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ASSESSMENT OF THE DIAGNOSTIC ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC CURVES
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ISO 21571:2005
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Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Nucleic acid extraction
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CLSI EP29 A : 1ED 2012
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EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
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ISO/IEC Guide 99:2007
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International vocabulary of metrology Basic and general concepts and associated terms (VIM)
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ISO 23640:2011
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In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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ISO 15190:2003
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Medical laboratories Requirements for safety
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CLSI MM1 A3 : 3ED 2012
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MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING
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ISO 21569:2005
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Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Qualitative nucleic acid based methods
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ISO 5725-2:1994
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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
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ISO 18113-2:2009
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
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CLSI MM13 A : 1ED 2006
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COLLECTION, TRANSPORT, PREPARATION, AND STORAGE OF SPECIMENS FOR MOLECULAR METHODS
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ISO 21748:2017
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Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty evaluation
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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ISO 18113-3:2009
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
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CLSI EP7 A2 : 2ED 2005
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INTERFERENCE TESTING IN CLINICAL CHEMISTRY
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CLSI MM3 A2 : 2ED 2006
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MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
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ISO/IEC Guide 98-3:2008
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Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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