ISO 5725-1:1994
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Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
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 |
EN 591 : 2001
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INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
EN 13612:2002/AC:2002
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PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES |
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 |
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 |
CLSI EP21 A : 1ED 2003
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ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS |
CLSI EP5 A2 : 2ED 2004
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EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
EN 592 : 2002
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INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
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 |
EN 13640:2002
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Stability testing of in vitro diagnostic reagents |
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 |
EN 376 : 2002
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INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
ISO/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
ISO 15198:2004
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Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer |
IEC 60068-2-64:2008
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Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
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 3534-2:2006
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Statistics Vocabulary and symbols Part 2: Applied statistics |
EN 375 : 2001
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INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
IEC 61000-4-2:2008
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Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
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 |
EN 13532:2002
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General requirements for in vitro diagnostic medical devices for self-testing |
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 |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
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 |
CLSI EP7 A2 : 2ED 2005
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INTERFERENCE TESTING IN CLINICAL CHEMISTRY |
CLSI EP18 A : 1ED 2002
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QUALITY MANAGEMENT FOR UNIT-USE TESTING |
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 |
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 |
EN 980:2008
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Symbols for use in the labelling of medical devices |
CLSI EP9 A2 : 2ED 2002
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METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
ISO 3534-1:2006
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Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
ISO 15223:2000
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |