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 15194:2009
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In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
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EN 591 : 2001
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INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
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EN 13612:2002/AC:2002
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PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
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ISO 15193:2009
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In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures
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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 EP21 A : 1ED 2003
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ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
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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 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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EN 592 : 2002
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INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
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ISO 18113-4:2009
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
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EN 13640:2002
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Stability testing of in vitro diagnostic reagents
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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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EN 376 : 2002
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INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
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ISO/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
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ISO 15198:2004
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Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
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IEC 60068-2-64:2008
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Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
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EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices
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ISO 17511:2003
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In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
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ISO 3534-2:2006
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Statistics — Vocabulary and symbols — Part 2: Applied statistics
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EN 375 : 2001
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INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
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IEC 61000-4-2:2008
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Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
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IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV
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Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
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EN 13532:2002
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General requirements for in vitro diagnostic medical devices for self-testing
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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 14971:2007
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Medical devices Application of risk management to medical devices
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ISO 18113-5:2009
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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CLSI EP7 A2 : 2ED 2005
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INTERFERENCE TESTING IN CLINICAL CHEMISTRY
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CLSI EP18 A : 1ED 2002
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QUALITY MANAGEMENT FOR UNIT-USE TESTING
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IEC 61010-1:2010+AMD1:2016 CSV
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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ISO 15197:2013
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In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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EN 980:2008
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Symbols for use in the labelling of medical devices
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CLSI EP9 A2 : 2ED 2002
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METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
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ISO 3534-1:2006
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Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
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ISO 15223:2000
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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