This part of IEC 60747-14 specifies the terms, definitions, symbols, tests, and performance evaluation methods used to determine the performance characteristics of wearable electrochemical-glucose sensors for practical use. This document is applicable to all wearable electrochemical-glucose sensors for consumers and manufacturers, without any limitations on device technology and size.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions 3.1 General terms <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Figures Figure 1 \u2013 Schematic of the electrochemical reaction of glucose <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Figure 2 \u2013 Schematic of the wearable and wireless glucose sensor system <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Figure 3 \u2013 Configuration of the three-electrode system <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Figure 4 \u2013 Configuration of the two-electrode system Figure 5 \u2013 Possible insertion location of the wearable glucose sensor <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 3.2 Characteristic parameters <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4 Essential ratings and characteristic parameters 4.1 Identification and type 4.2 Limiting values and operating conditions 4.3 Additional information 5 Test method 5.1 General Tables Table 1 \u2013 Table of specifications for the wearable electrochemical-glucose sensor <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | Figure 6 \u2013 In vitro test and evaluation set-up for the wearableelectrochemical-glucose sensor Figure 7 \u2013 Preclinical test and evaluation set-up for the wearableelectrochemical-glucose sensor <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.2 In vitro evaluation 5.2.1 Test procedure Figure 8 \u2013 Clinical test and evaluation set-up for the wearableelectrochemical-glucose sensor Figure 9 \u2013 In vitro measurement procedure of the glucose sensor <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.2.2 Sensitivity 5.2.3 Selectivity Figure 10 \u2013 Sensitivity of the glucose sensor Figure 11 \u2013 Selectivity of the glucose sensor <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 5.2.4 Response time 5.2.5 Linearity Figure 12 \u2013 Response time of the glucose sensor <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.2.6 Repeatability 5.2.7 Reliability Figure 13 \u2013 Linearity of the glucose sensor Figure 14 \u2013 Repeatability of the glucose sensor <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.2.8 Limit of detection 5.2.9 Regression equation between output value and concentration Figure 15 \u2013 Reliability of the glucose sensor Figure 16 \u2013 Limit of detection of the glucose sensor <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.2.10 Matching data between output value and concentration Figure 17 \u2013 Regression analysis between output value and reference glucose value Table 2 \u2013 Matching table between output value and reference glucose value <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.3 Preclinical investigation 5.3.1 Test protocol 5.3.2 Effectiveness of evaluation procedure Figure 18 \u2013 Preclinical test procedure of glucose <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.3.3 Analytical performance evaluation Table 3 \u2013 Glucose concentration intervals for the measurement ofrepeatability, reliability, and accuracy <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Table 4 \u2013 Glucose concentration of samples for accuracy evaluation <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 5.4 Clinical evaluation 5.4.1 Test protocol 5.4.2 Clinical investigation procedure Figure 19 \u2013 Glucose clinical test procedure <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 5.4.3 Analytical performance evaluation <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Annex A (informative)Possible interfering substances A.1 Purpose A.2 List of the possible interfering substances <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Annex B (informative)Consensus error grid B.1 Purpose B.2 Graphs Figure B.1 \u2013 Consensus error grid (mmol\/l) <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | B.3 Table Figure B.2 \u2013 Consensus error grid (mg\/dl) Table B.1 \u2013 Risk categories <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Annex C (informative)ISO 15197:2013 error grid C.1 Purpose C.2 Graphs Figure C.1 \u2013 Error grid adapted from ISO 15197:2013:Measured glucose value-concentration plot (mg\/dl) <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Figure C.2 \u2013 Error grid adapted from ISO 15197:2013:Measured glucose value-concentration plot (mmol\/l) Figure C.3 \u2013 Error grid adapted from ISO 15197:2013:Difference-concentration plot (mg\/dl) <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Figure C.4 \u2013 Error grid adapted from ISO 15197:2013:Difference-concentration plot (mmol\/l) <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Semiconductor devices – Semiconductor sensors. Performance evaluation methods for wearable glucose sensors<\/b><\/p>\n |