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UNE-EN ISO 17511:2004

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

Available format(s)

Hardcopy , PDF

Superseded date

02-03-2022

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 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.

Committee
CTN 129
DocumentType
Standard
Pages
32
PublisherName
Asociacion Espanola de Normalizacion
Status
Superseded
SupersededBy
Supersedes

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