ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories
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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 10241:1992
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International terminology standards Preparation and layout
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ISO 1087-1:2000
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Terminology work Vocabulary Part 1: Theory and application
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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 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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IEC 60601-1-6:2010+AMD1:2013 CSV
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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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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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CFR 21(PTS800-1299) : 0
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FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
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EN 13640:2002
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Stability testing of in vitro diagnostic reagents
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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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EN 376 : 2002
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INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
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CLSI GP10 A : 1ED 95(R2001)
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ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
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CLSI EP6 A : 1ED 2003
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EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
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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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ISO 18153:2003
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In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
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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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ISO/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards
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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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CLSI C28 A2 : 2ED 2000
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HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY
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ISO 3534-2:2006
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Statistics — Vocabulary and symbols — Part 2: Applied statistics
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ISO 15190:2003
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Medical laboratories Requirements for safety
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ISO 8601:2004
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Data elements and interchange formats Information interchange Representation of dates and times
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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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ISO Guide 30:2015
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Reference materials Selected terms and definitions
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CLSI EP32 R : 1ED 2006
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METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
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CFR 29(PT1910.1000 TO END) : 0
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LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
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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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CLSI EP17 A : 1ED 2004
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PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
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ISO 17593:2007
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Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary
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IEC 60359:2001
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Electrical and electronic measurement equipment - Expression of performance
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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 704:2009
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Terminology work — Principles and methods
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CLSI EP7 A2 : 2ED 2005
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INTERFERENCE TESTING IN CLINICAL CHEMISTRY
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ISO 15223-1:2016
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied 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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IEC 60050-300:2001
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International Electrotechnical Vocabulary (IEV) - Part 300: Electrical and electronic measurements and measuring instruments - Part 311: General terms relating to measurements - Part 312: General terms relating to electrical measurements - Part 313: Types of electrical measuring instruments - Part 314: Specific terms according to the type of instrument
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ISO 5725-5:1998
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Accuracy (trueness and precision) of measurement methods and results — Part 5: Alternative methods for the determination of the precision of a standard measurement method
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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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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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