BS EN ISO 15197:2013
$198.66
In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus
| Published By | Publication Date | Number of Pages |
| BSI | 2013 | 60 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 5 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC in vitro diagnostic medical devices Table ZA.1 — Correspondence between this European Standard and Directive 98/79/EC in vitro diagnostic medical devices |
| 8 | Foreword |
| 9 | Introduction |
| 11 | Section sec_1 Section sec_2 1 Scope 2 Normative references |
| 12 | Section sec_3 Section sec_3.1 Section sec_3.2 Section sec_3.3 Section sec_3.4 3 Terms and definitions |
| 13 | Section sec_3.5 Section sec_3.6 Section sec_3.7 Section sec_3.8 |
| 14 | Section sec_3.9 Section sec_3.10 Section sec_3.11 Section sec_3.12 Section sec_3.13 |
| 15 | Section sec_3.14 Section sec_3.15 Section sec_3.16 |
| 16 | Section sec_3.17 Section sec_3.18 Section sec_3.19 |
| 17 | Section sec_3.20 Section sec_3.21 Section sec_3.22 Section sec_3.23 Section sec_3.24 |
| 18 | Section sec_3.25 Section sec_3.26 Section sec_3.27 Section sec_3.28 Section sec_4 Section sec_4.1 Section sec_4.2 4 Design and development 4.1 General requirements 4.2 Metrological traceability |
| 19 | Section sec_4.3 Section sec_4.3.1 Section sec_4.3.2 Section sec_4.3.3 4.3 Safety and risk management |
| 20 | Section sec_4.4 Section sec_4.5 Section sec_5 Section sec_5.1 Section sec_5.1.1 4.4 Ergonomics and human factors 4.5 User verification requirements 5 Safety and reliability testing 5.1 General requirements |
| 21 | Section sec_5.1.2 Section sec_5.1.3 Section sec_5.2 Section sec_5.3 Section sec_5.4 Section sec_5.5 Section sec_5.6 5.2 Protection against electric shock 5.3 Protection against mechanical hazards 5.4 Electromagnetic compatibility 5.5 Resistance to heat 5.6 Resistance to moisture and liquids |
| 22 | Section sec_5.7 Section sec_5.8 Section sec_5.9 Section sec_5.10 Section sec_5.10.1 Section sec_5.10.2 5.7 Protection against liberated gases, explosion and implosion 5.8 Meter components 5.9 Performance test 5.10 Mechanical resistance to vibration and shock |
| 23 | Section sec_5.11 Section sec_5.11.1 Section sec_5.11.2 Section sec_5.12 5.11 Equipment temperature exposure limits for storage 5.12 Equipment humidity exposure limits for storage |
| 24 | Section sec_6 Section sec_6.1 Section sec_6.1.1 Section sec_6.1.2 6 Analytical performance evaluation 6.1 General requirements |
| 25 | Section sec_6.1.3 Section sec_6.1.4 |
| 26 | Section sec_6.2 Section sec_6.2.1 Section sec_6.2.2 Section sec_6.2.3 Section sec_6.2.3.1 Section sec_6.2.3.2 6.2 Measurement precision |
| 27 | Table tab_1 Section sec_6.2.3.3 Section sec_6.2.3.4 |
| 28 | Section sec_6.2.4 Section sec_6.2.4.1 Section sec_6.2.4.2 Table tab_2 Section sec_6.2.4.3 |
| 29 | Section sec_6.2.4.4 Section sec_6.3 Section sec_6.3.1 Section sec_6.3.2 6.3 System accuracy |
| 30 | Section sec_6.3.3 Section sec_6.3.4 Section sec_6.3.5 |
| 31 | Table tab_3 Section sec_6.3.6 |
| 32 | Section sec_6.3.7 Section sec_6.3.7.1 Section sec_6.3.7.2 |
| 33 | Table tab_a Figure fig_1 |
| 34 | Table tab_b Figure fig_2 Section sec_6.3.7.3 |
| 35 | Section sec_6.3.7.4 Table tab_4 Table tab_5 Table tab_6 Section sec_6.4 Section sec_6.4.1 6.4 Influence quantities |
| 36 | Section sec_6.4.2 Section sec_6.4.3 Section sec_6.4.3.1 Section sec_6.4.3.2 Section sec_6.4.3.3 |
| 37 | Section sec_6.4.3.4 Section sec_6.4.3.5 |
| 38 | Section sec_6.4.4 Section sec_6.4.4.1 Section sec_6.4.4.2 Section sec_6.4.4.3 |
| 39 | Section sec_6.4.4.4 Section sec_6.4.4.5 |
| 40 | Section sec_6.5 Section sec_6.5.1 Section sec_6.5.2 Section sec_7 Section sec_7.1 6.5 Stability of reagents and materials 7 Information supplied by the manufacturer 7.1 General requirements |
| 41 | Section sec_7.2 Section sec_7.3 Section sec_8 Section sec_8.1 7.2 Performance characteristics 7.3 Options for supplying instructions for use 8 User performance evaluation 8.1 General requirements |
| 42 | Section sec_8.2 Section sec_8.3 Section sec_8.4 8.2 Acceptance criteria and evaluation of results 8.3 Selection and preparation of subjects 8.4 Execution of study protocol |
| 43 | Section sec_8.5 Section sec_8.6 Section sec_8.7 Section sec_8.7.1 8.5 Glucose reference values 8.6 Human factors 8.7 Data analysis and presentation of results |
| 44 | Section sec_8.7.2 Section sec_8.8 Section sec_8.8.1 Section sec_8.8.2 Section sec_8.8.3 8.8 Evaluation of instructions for use |
| 45 | Annex sec_A Annex sec_A.1 Annex sec_A.2 Annex A (informative) Possible interfering substances |
| 46 | Annex sec_B Figure fig_B.1 Annex B (informative) Traceability chain |
| 48 | Annex sec_C Annex sec_C.1 Annex sec_C.2 Annex sec_C.3 Annex C (informative) Rationale for the analytical performance requirements Rationale for the analytical performance requirements |
| 49 | Annex sec_C.4 |
| 50 | Table tab_C.1 |
| 52 | Table tab_e Figure fig_C.1 |
| 53 | Table tab_f Figure fig_C.2 Table tab_C.2 |
| 54 | Annex sec_C.5 |
| 55 | Reference ref_1 Reference ref_2 Reference ref_3 Reference ref_4 Reference ref_5 Reference ref_6 Reference ref_7 Reference ref_8 Reference ref_9 Reference ref_10 Reference ref_11 Reference ref_12 Reference ref_13 Reference ref_14 Reference ref_15 Reference ref_16 Reference ref_17 Reference ref_18 Bibliography Bibliography |
| 56 | Reference ref_19 Reference ref_20 |
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