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UNE-EN ISO 18153:2004

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 (ISO 18153:2003)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

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

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
CTN 129
DocumentType
Standard
Pages
20
PublisherName
Asociacion Espanola de Normalizacion
Status
Current

€81.60
Excluding VAT

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