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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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DIN 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 (IEC 61326-2-6:2012)
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DIN EN ISO 23640:2015-12
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011)
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|
DIN ISO 5725-2:2002-12
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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 5725-2:1994 including Technical Corrigendum 1:2002)
|
|
DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
|
|
DIN EN ISO 17511:2003-11
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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)
|
|
IEC 61326-2-6:2012
|
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
|
|
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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DIN EN 61326-1 : 2013
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ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 1: GENERAL REQUIREMENTS (IEC 61326-1:2012)
|
|
DIN EN 60068-2-64 : 1995
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ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
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DIN ISO 3534-1:2009-10
|
STATISTICS - VOCABULARY AND SYMBOLS - PART 1: GENERAL STATISTICAL TERMS AND TERMS USED IN PROBABILITY
|
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DIN EN 62366 : 2016
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
|
|
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes
|
|
ISO 18113-4:2009
|
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
|
|
DIN ISO 5725-3:2003-02
|
ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS - PART 3: INTERMEDIATE MEASURES OF THE PRECISION OF A STANDARD MEASUREMENT METHOD
|
|
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
|
|
DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
|
|
IEC 60068-2-64:2008
|
Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
|
|
IEC 62366:2007+AMD1:2014 CSV
|
Medical devices - Application of usability engineering to medical devices
|
|
DIN EN ISO 18113-4:2013-01
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
|
|
DIN ISO 5725-1:1997-11
|
ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS - PART 1: GENERAL PRINCIPLES AND DEFINITIONS
|
|
ISO/IEC Guide 99:2007
|
International vocabulary of metrology Basic and general concepts and associated terms (VIM)
|
|
ISO 23640:2011
|
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
|
|
ISO 17511:2003
|
In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
|
|
DIN EN ISO 18113-5:2013-01
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
|
|
ISO 5725-2:1994
|
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
|
|
DIN EN 61010-1 : 2011
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
|
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices
|
|
ISO 18113-5:2009
|
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
|
|
IEC 61010-1:2010+AMD1:2016 CSV
|
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
|
|
DIN EN ISO 15194:2009-10
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION
|
|
DIN EN ISO 18113-1:2013-01
|
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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