European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Characterization toolbox: performance characteristics
6 Method development
7 Intra-laboratory validation (V1) – option 1, basic procedure
8 Intra-laboratory validation (V1) – option 2, including verification of the LOQ
9 Interlaboratory validation 2 (V2)
10 Validation report
Annex A (normative) Intra-laboratory validation
Annex B (normative) Module C: Intra-laboratory performance
Annex C (normative) Module D: Requirements on the study for inter-laboratory validation
Annex D (informative) Structure and content of a validation study documentation (V2)
Annex E (informative) Robustness testing by systematic variation of influencing factors
Annex F (informative) Protocol for spiking of solid matrices
Bibliography