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SN EN ISO 18153 : 2003

Current

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

Published date

12-01-2013

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.

DocumentType
Standard
PublisherName
Swiss Standards
Status
Current

Standards Relationship
EN ISO 18153:2003 Identical
UNI EN ISO 18153 : 2004 Identical
BS EN ISO 18153:2003 Identical
ISO 18153:2003 Identical
UNE-EN ISO 18153:2004 Identical
DIN EN ISO 18153:2003-11 Identical

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