I.S. EN ISO 16140-2:2016
Current
The latest, up-to-date edition.
MICROBIOLOGY OF THE FOOD CHAIN - METHOD VALIDATION - PART 2: PROTOCOL FOR THE VALIDATION OF ALTERNATIVE (PROPRIETARY) METHODS AGAINST A REFERENCE METHOD (ISO 16140-2:2016)
Hardcopy , PDF
English
01-01-2016
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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
Defines the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain.
| DevelopmentNote |
Supersedes I.S. EN ISO 16140. (08/2016)
|
| DocumentType |
Standard
|
| Pages |
84
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 16140-2:2016 | Identical |
| EN ISO 16140-2:2016 | Identical |
| ISO 16297:2013 | Milk Bacterial count Protocol for the evaluation of alternative methods |
| ISO 16140-1:2016 | Microbiology of the food chain — Method validation — Part 1: Vocabulary |
| ISO/TS 22117:2010 | Microbiology of food and animal feeding stuffs Specific requirements and guidance for proficiency testing by interlaboratory comparison |
| ISO 11133:2014 | Microbiology of food, animal feed and water — Preparation, production, storage and performance testing of culture media |
| ISO 5725-2:1994 | Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method |
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