I.S. EN ISO 16140-2:2016
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
01-01-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles for the validation of alternative
methods
5 Qualitative methods - Technical protocol for validation
6 Quantitative methods - Technical protocol for validation
Annex A (informative) - Classification of sample types
and suggested target combinations for validation
studies
Annex B (normative) - Order of preference for use of
naturally and artificially contaminated samples
in validation studies
Annex C (informative) - General protocols for
contamination by mixture and artificial
contamination of foods
Annex D (informative) - Models for RLOD calculations
using data from the method comparison study
Annex E (normative) - Points to be considered when
selecting strains for testing inclusivity and
exclusivity
Annex F (informative) - Considerations for calculations of
the relative level of detection (RLOD) between
laboratories as obtained in an interlaboratory
study
Annex G (informative) - Principle of the accuracy profile
for validation of quantitative models
Annex H (informative) - Application of the accuracy
profile in the method comparison study
Annex I (informative) - Example of the application of the
accuracy profile for an interlaboratory study
Bibliography
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