{"id":340649,"date":"2024-10-19T23:52:10","date_gmt":"2024-10-19T23:52:10","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-16140-22016\/"},"modified":"2024-10-25T23:02:34","modified_gmt":"2024-10-25T23:02:34","slug":"bs-en-iso-16140-22016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-16140-22016\/","title":{"rendered":"BS EN ISO 16140-2:2016"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions 4 General principles for the validation of alternative methods <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 5 Qualitative methods \u2014 Technical protocol for validation 5.1 Method comparison study 5.1.1 General considerations 5.1.2 Paired or unpaired study 5.1.3 Sensitivity study <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 5.1.4 Relative level of detection study <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 5.1.5 Inclusivity and exclusivity study <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 5.2 Interlaboratory study 5.2.1 General considerations 5.2.2 Measurement protocol <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 5.2.3 Calculations and summary of data <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | 5.2.4 Interpretation of data <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 6 Quantitative methods \u2014 Technical protocol for validation 6.1 Method comparison study 6.1.1 General considerations 6.1.2 Relative trueness study <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | 6.1.3 Accuracy profile study <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | 6.1.4 Limit of quantification study 6.1.5 Inclusivity and exclusivity study <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | 6.2 Interlaboratory study 6.2.1 General considerations 6.2.2 Measurement protocol <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | 6.2.3 Calculations, summary, and interpretation of data <\/td>\n<\/tr>\n | ||||||
38<\/td>\n | Annex\u00a0A (informative) Classification of sample types and suggested target combinations for validation studies <\/td>\n<\/tr>\n | ||||||
54<\/td>\n | Annex\u00a0B (normative) Order of preference for use of naturally and artificially contaminated samples in validation studies <\/td>\n<\/tr>\n | ||||||
55<\/td>\n | Annex\u00a0C (informative) General protocols for contamination by mixture and artificial contamination of foods <\/td>\n<\/tr>\n | ||||||
58<\/td>\n | Annex\u00a0D (informative) Models for RLOD calculations using data from the method comparison study <\/td>\n<\/tr>\n | ||||||
60<\/td>\n | Annex\u00a0E (normative) Points to be considered when selecting strains for testing inclusivity and exclusivity <\/td>\n<\/tr>\n | ||||||
62<\/td>\n | Annex\u00a0F (informative) Considerations for calculations of the relative level of detection (RLOD) between laboratories as obtained in an interlaboratory study <\/td>\n<\/tr>\n | ||||||
65<\/td>\n | Annex\u00a0G (informative) Principle of the accuracy profile for validation of quantitative models <\/td>\n<\/tr>\n | ||||||
67<\/td>\n | Annex\u00a0H (informative) Application of the accuracy profile in the method comparison study <\/td>\n<\/tr>\n | ||||||
70<\/td>\n | Annex\u00a0I (informative) Example of the application of the accuracy profile for an interlaboratory study <\/td>\n<\/tr>\n | ||||||
74<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Microbiology of the food chain. Method validation – Protocol for the validation of alternative (proprietary) methods against a reference method<\/b><\/p>\n |