UNE-EN ISO 18153:2004
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
Hardcopy , PDF
Spanish, Castilian, English
07-04-2004
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Metrological traceability chain and calibration hierarchy
4.1 Principles
4.2 Structure
5 Validation of metrologically traceable calibration
5.1 Principles
5.2 Analytical specificity of measurement procedures
5.3 Commutability of calibrators
5.4 Commutability of control materials
Annex A (informative) List of IFCC primary reference measurement
procedures
Annex B (informative) List of certified reference materials (CRM)
Annex ZA (informative) Clauses of this European Standard addressing
essential requirements or other provisions of EU Directives
Bibliography
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