ISO 15193:2009
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

Standard No.

ISO 15193:2009

Release Date

2009

Published By

International Organization for Standardization (ISO)

Latest

ISO 15193:2009

ISO 15193:2009 Referenced Document

• DIN 1333 Presentation of numerical data
• ISO 15194 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
• ISO 17511 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples*， 2020-04-24 Update
• ISO 18153 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
• ISO 3696 Water for analytical laboratory use; Specification and test methods
• ISO 4791-1 Laboratory apparatus; Vocabulary relating to apparatus made essentially from glass, porcelain or vitreous silica; Part 1 : Names for items of apparatus Trilingual edition
• ISO 5725-1 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions*， 2023-07-01 Update
• ISO 5725-2 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*， 2019-12-06 Update
• ISO 5725-3 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate precision and alternative designs for collaborative studies*， 2023-06-01 Update
• ISO 5725-4 Accuracy (trueness and precision) of measurement methods and results — Part 4: Basic methods for the determination of the trueness of a standard measurement method*， 2020-03-26 Update
• ISO 5725-5 Accuracy (trueness and precision) of measurement methods and results - Part 5: Alternative methods for the determination of the precision of a standard measurement method; Technical Corrigendum 1
• ISO 5725-6 Accuracy (trueness and precision) of measurement methods and results - Part 6: Use in practice of accuracy values; Technical Corrigendum 1
• ISO 6353-2 Reagents for chemical analysis — Part 2: Specifications — First series — Addendum 2
• ISO 6353-3 Reagents for chemical analysis; Part 3 : Specifications; Second series
• ISO 78-2 Chemistry - Layouts for standards - Part 2: Methods of chemical analysis
• ISO Guide 32 Calibration in analytical chemistry and use of certified reference materials
• ISO Guide 33 Reference materials - Good practice in using reference materials*， 2015-02-01 Update
• ISO Guide 34 General requirements for the competence of reference material producers
• ISO/IEC Guide 15 ISO/IEC-code of principles on "reference to standards"
• ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
• ISO/IEC Guide 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)

ISO 15193:2009 history

• 2009 ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
• 2002 ISO 15193:2002 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures