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