S.R. CEN/TS 16800:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
GUIDELINE FOR THE VALIDATION OF PHYSICO-CHEMICAL ANALYTICAL METHODS
Hardcopy , PDF
05-13-2021
English
01-01-2015
National Foreword
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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