BS IEC 60747-14-10:2019
$167.15
Semiconductor devices – Semiconductor sensors. Performance evaluation methods for wearable glucose sensors
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 36 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 4 | English CONTENTS |
| 6 | FOREWORD |
| 8 | 1 Scope 2 Normative references 3 Terms and definitions 3.1 General terms |
| 9 | Figures Figure 1 – Schematic of the electrochemical reaction of glucose |
| 10 | Figure 2 – Schematic of the wearable and wireless glucose sensor system |
| 11 | Figure 3 – Configuration of the three-electrode system |
| 12 | Figure 4 – Configuration of the two-electrode system Figure 5 – Possible insertion location of the wearable glucose sensor |
| 13 | 3.2 Characteristic parameters |
| 15 | 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 – Table of specifications for the wearable electrochemical-glucose sensor |
| 16 | Figure 6 – In vitro test and evaluation set-up for the wearableelectrochemical-glucose sensor Figure 7 – Preclinical test and evaluation set-up for the wearableelectrochemical-glucose sensor |
| 17 | 5.2 In vitro evaluation 5.2.1 Test procedure Figure 8 – Clinical test and evaluation set-up for the wearableelectrochemical-glucose sensor Figure 9 – In vitro measurement procedure of the glucose sensor |
| 18 | 5.2.2 Sensitivity 5.2.3 Selectivity Figure 10 – Sensitivity of the glucose sensor Figure 11 – Selectivity of the glucose sensor |
| 19 | 5.2.4 Response time 5.2.5 Linearity Figure 12 – Response time of the glucose sensor |
| 20 | 5.2.6 Repeatability 5.2.7 Reliability Figure 13 – Linearity of the glucose sensor Figure 14 – Repeatability of the glucose sensor |
| 21 | 5.2.8 Limit of detection 5.2.9 Regression equation between output value and concentration Figure 15 – Reliability of the glucose sensor Figure 16 – Limit of detection of the glucose sensor |
| 22 | 5.2.10 Matching data between output value and concentration Figure 17 – Regression analysis between output value and reference glucose value Table 2 – Matching table between output value and reference glucose value |
| 23 | 5.3 Preclinical investigation 5.3.1 Test protocol 5.3.2 Effectiveness of evaluation procedure Figure 18 – Preclinical test procedure of glucose |
| 24 | 5.3.3 Analytical performance evaluation Table 3 – Glucose concentration intervals for the measurement ofrepeatability, reliability, and accuracy |
| 25 | Table 4 – Glucose concentration of samples for accuracy evaluation |
| 26 | 5.4 Clinical evaluation 5.4.1 Test protocol 5.4.2 Clinical investigation procedure Figure 19 – Glucose clinical test procedure |
| 27 | 5.4.3 Analytical performance evaluation |
| 28 | Annex A (informative)Possible interfering substances A.1 Purpose A.2 List of the possible interfering substances |
| 29 | Annex B (informative)Consensus error grid B.1 Purpose B.2 Graphs Figure B.1 – Consensus error grid (mmol/l) |
| 30 | B.3 Table Figure B.2 – Consensus error grid (mg/dl) Table B.1 – Risk categories |
| 31 | Annex C (informative)ISO 15197:2013 error grid C.1 Purpose C.2 Graphs Figure C.1 – Error grid adapted from ISO 15197:2013:Measured glucose value-concentration plot (mg/dl) |
| 32 | Figure C.2 – Error grid adapted from ISO 15197:2013:Measured glucose value-concentration plot (mmol/l) Figure C.3 – Error grid adapted from ISO 15197:2013:Difference-concentration plot (mg/dl) |
| 33 | Figure C.4 – Error grid adapted from ISO 15197:2013:Difference-concentration plot (mmol/l) |
| 34 | Bibliography |
