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PD CEN/TS 16800:2015
Superseded
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Guideline for the validation of physico-chemical analytical methods
Hardcopy , PDF
08-01-2021
English
31-12-2015
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Concept
5 Documentation of the validation process
6 Validation 1 (V1): Intra-Laboratory Validation
7 Validation 2 (V2): Inter-Laboratory Validation
Annex A (normative) - Module A: Test method definition,
documentation and general requirements
Annex B (normative) - Module B: Applicability domain and
pre-validation
Annex C (normative) - Module C: Intra-laboratory
performance
Annex D (normative) - Module D: Requirements for an
inter-laboratory validation study
Annex E (informative) - Structure and content of the
documentation for a validation study (V2)
Annex F (informative) - Robustness testing by systematic
variation of influencing factors
Bibliography
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