GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (Text of Document is in English)

01/09/2008

48P

$200.00 USD

Contents
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 calibrators) giving metrological traceability to SI
5.3 Cases with international conventional reference measurement procedure (which is not primary) and international conventional calibrators) 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
Bibliography