DIN EN ISO 18153:2003-11
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
Hardcopy , PDF
English, German
01-01-2003
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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)
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.
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Standards | Relationship |
| NS EN ISO 18153 : 1ED 2003 | Identical |
| I.S. EN ISO 18153:2003 | Identical |
| NF EN ISO 18153 : 2004 | Identical |
| ISO 18153:2003 | Identical |
| BS EN ISO 18153:2003 | Identical |
| SN EN ISO 18153 : 2003 | Identical |
| UNE-EN ISO 18153:2004 | Identical |
| NEN EN ISO 18153 : 2003 | Identical |
| UNI EN ISO 18153 : 2004 | Identical |
| EN ISO 18153:2003 | Identical |
| EN 12286:1998/A1:2000 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES |
| EN 12287 : 1999 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS |
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