PREN ISO 16140-2 : DRAFT 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MICROBIOLOGY OF FOOD AND ANIMAL FEED - METHOD VALIDATION - PART 2: PROTOCOL FOR THE VALIDATION OF ALTERNATIVE (PROPRIETARY) METHODS AGAINST A REFERENCE METHOD (ISO/DIS 16140-2:2013)
07-01-2016
05-09-2013
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 artificially contamination of food
matrices
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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