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NS EN ISO 17511 : 1ED 2003

Current

Current

The latest, up-to-date edition.

IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN BIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES 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 and nomenclature
   4.3 Considerations in establishing metrological
       traceability
   4.4 Functions of reference materials
5 Calibration transfer protocols
   5.1 Availability and structure
   5.2 Cases with primary reference measurement procedure and
       primary calibrator(s) giving metrological traceability to
       SI
   5.3 Cases with international conventional reference
       measurement procedure (which is not primary) and
       international conventional calibrator(s) without
       metrological traceability to SI
   5.4 Cases with international conventional reference
       measurement procedure (which is not primary) but no
       international conventional calibrator and without
       metrological traceability to SI
   5.5 Cases with international conventional calibrator
       (which is not primary) but no international
       conventional reference measurement procedure and
       without metrological traceability to SI
   5.6 Cases with manufacturer's selected measurement
       procedure but neither international conventional
       reference measurement procedure nor international
       conventional calibrator and without metrological
       traceability to SI
   5.7 Trueness control materials
6 Expression of uncertainty of measurement
7 Validation of metrologically traceable calibration
8 Information on metrological traceability to be given
   in the instructions for use of an in vitro diagnostic
   medical device
Annex ZA (informative) Clauses of this European Standard
                       addressing essential requirements
                       or other provisions of EU Directives
Bibliography

Describes how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Current

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