{"id":402066,"date":"2024-10-20T04:59:24","date_gmt":"2024-10-20T04:59:24","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-21474-22022\/"},"modified":"2024-10-26T08:51:15","modified_gmt":"2024-10-26T08:51:15","slug":"bs-iso-21474-22022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-21474-22022\/","title":{"rendered":"BS ISO 21474-2:2022"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
2<\/td>\n | National foreword <\/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 <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 4 General requirements 4.1 General 4.2 Laboratory requirements <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 4.3 Reagents requirements 4.4 Apparatus and equipment 4.5 Reference and control materials 4.5.1 General <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 4.5.2 Endogenous nucleic acid 4.5.3 Nongenomic reference materials (RMs) 4.6 Calibration of the analysis 4.7 Input range <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 5 Evaluation of performance characteristics 5.1 General 5.2 Analytical specificity 5.2.1 Analytical reactivity <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 5.2.2 Limit of blank 5.2.3 Cross-reactivity <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 5.2.4 Exclusivity 5.2.5 Interfering substances and carryover 5.3 Range of reliable signal, reportable range and reference range 5.4 Limit of detection of multiplex molecular test platform (LODP) <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 5.5 Measurement precision and uncertainty 5.6 Accuracy and method comparison studies <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | Annex A (informative) Certified reference materials (CRMs) <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | Annex B (informative) Example of human genome reference materials (RMs) <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids – Validation and verification<\/b><\/p>\n |