S.R. CEN/TS 16800:2020
Current
The latest, up-to-date edition.
Guideline for the validation of physico-chemical analytical methods
Hardcopy , PDF
English
25-01-2021
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
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