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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2003

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Covers 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	38
PublisherName	National Standards Authority of Ireland
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