In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
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ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Presentation of a reference measurement procedure
4.1 Elements of a reference measurement procedure
4.2 Warning and safety precautions
4.3 Introduction
4.4 Scope
4.5 Terms, definitions, symbols and abbreviated terms
4.6 Measurement principle and measurement method
4.7 Check list
4.8 Reagents and materials
4.9 Apparatus
4.10 Sampling and sample
4.11 Preparation of measuring system and analytical portion
4.12 Operation of measuring system
4.13 Data processing
4.14 Analytical reliability
4.15 Special cases
4.16 Validation of a reference measurement procedure
4.17 Reporting
4.18 Quality assurance
4.19 Bibliography
4.20 Dates of authorization and revision
Annex A Reference procedures for properties other than differential and rational quantities (informative)
ISO 15194:2009 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/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 15194:2009 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/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)