UNI 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
01-04-2004
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
Defines how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Standards | Relationship |
| ISO 18153:2003 | Identical |
| UNE-EN ISO 18153:2004 | Identical |
| NEN EN ISO 18153 : 2003 | Identical |
| EN ISO 18153:2003 | Identical |
| BS EN ISO 18153:2003 | Identical |
| NS EN ISO 18153 : 1ED 2003 | Identical |
| I.S. EN ISO 18153:2003 | Identical |
| SN EN ISO 18153 : 2003 | Identical |
| NF EN ISO 18153 : 2004 | Identical |
| DIN EN ISO 18153:2003-11 | Identical |
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