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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IEC 61326-2-6:2012
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Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
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EN ISO 18113-1:2011
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
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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 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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EN 61326-2-6:2013
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Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
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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 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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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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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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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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IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices
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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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EN 61326-1:2013
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Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
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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 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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EN ISO 23640:2015
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In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
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EN 62366 : 2008 AMD 1 2015
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
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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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EN ISO 14971:2012
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Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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EN 61010-1:2010
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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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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EN ISO 18113-5:2011
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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EN 61010-2-101:2017
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Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
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CLSI EP7 A2 : 2ED 2005
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INTERFERENCE TESTING IN CLINICAL CHEMISTRY
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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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CLSI EP9 A2 : 2ED 2002
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METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
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EN 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 (ISO 17511:2003)
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CLSI EP30 A : 1ED 2010
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CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
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