QUALITY ASSURANCE OF POCT RESULTS - ASSESSMENT CRITERIA FOR COMPARISON MEASUREMENT AND IMPLEMENTATION

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviations
5 Requirements
6 Concordance of measurands
7 Concordance analysis when implementing POCT
8 Checking the concordance analysis
Annex A (informative) - Example of concordance analyses
Bibliography

Describes measures for the analytical and clinical assessment of a measurand when using different diagnostic methods (both POCT and non-POCT) in medical diagnostic testing.

DocumentType	Standard
Pages	16
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

ISO 15189:2012	Medical laboratories — Requirements for quality and competence
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
IEC 60050-300:2001	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