ISO 15197:2013
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_3.21
Section sec_3.22
Section sec_3.23
Section sec_3.24
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
Section sec_4.3
Section sec_4.3.1
Section sec_4.3.2
Section sec_4.3.3
Section sec_4.4
Section sec_4.5
Section sec_5
Section sec_5.1
Section sec_5.1.1
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
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
Section sec_5.11
Section sec_5.11.1
Section sec_5.11.2
Section sec_5.12
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
Section sec_6.1.3
Section sec_6.1.4
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
Table tab_1
Section sec_6.2.3.3
Section sec_6.2.3.4
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
Section sec_6.2.4.4
Section sec_6.3
Section sec_6.3.1
Section sec_6.3.2
Section sec_6.3.3
Section sec_6.3.4
Section sec_6.3.5
Table tab_3
Section sec_6.3.6
Section sec_6.3.7
Section sec_6.3.7.1
Section sec_6.3.7.2
Table tab_a
Figure fig_1
Table tab_b
Figure fig_2
Section sec_6.3.7.3
Section sec_6.3.7.4
Table tab_4
Table tab_5
Table tab_6
Section sec_6.4
Section sec_6.4.1
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
Section sec_6.4.3.4
Section sec_6.4.3.5
Section sec_6.4.4
Section sec_6.4.4.1
Section sec_6.4.4.2
Section sec_6.4.4.3
Section sec_6.4.4.4
Section sec_6.4.4.5
Section sec_6.5
Section sec_6.5.1
Section sec_6.5.2
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_8.3
Section sec_8.4
Section sec_8.5
Section sec_8.6
Section sec_8.7
Section sec_8.7.1
Section sec_8.7.2
Section sec_8.8
Section sec_8.8.1
Section sec_8.8.2
Section sec_8.8.3
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_B
Figure fig_B.1
Annex sec_C
Annex sec_C.1
Annex sec_C.2
Annex sec_C.3
Annex sec_C.4
Table tab_C.1
Table tab_e
Figure fig_C.1
Table tab_f
Figure fig_C.2
Table tab_C.2
Annex sec_C.5
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
Reference ref_19
Reference ref_20
Annex C (informative) Rationale for the analytical performance requirements
Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design and development
4.1 General requirements
4.2 Metrological traceability
4.3 Safety and risk management
4.4 Ergonomics and human factors
4.5 User verification requirements
5 Safety and reliability testing
5.1 General requirements
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
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
5.11 Equipment temperature exposure limits for storage
5.12 Equipment humidity exposure limits for storage
6 Analytical performance evaluation
6.1 General requirements
6.2 Measurement precision
6.3 System accuracy
6.4 Influence quantities
6.5 Stability of reagents and materials
7 Information supplied by the manufacturer
7.1 General requirements
7.2 Performance characteristics
7.3 Options for supplying instructions for use
8 User performance evaluation
8.1 General requirements
8.2 Acceptance criteria and evaluation of results
8.3 Selection and preparation of subjects
8.4 Execution of study protocol
8.5 Glucose reference values
8.6 Human factors
8.7 Data analysis and presentation of results
8.8 Evaluation of instructions for use
Annex A (informative) Possible interfering substances
Annex B (informative) Traceability chain
Annex C (informative) Rationale for the analytical performance requirements
Bibliography
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16
Section sec_3.17
Section sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_3.21
Section sec_3.22
Section sec_3.23
Section sec_3.24
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
Section sec_4.3
Section sec_4.3.1
Section sec_4.3.2
Section sec_4.3.3
Section sec_4.4
Section sec_4.5
Section sec_5
Section sec_5.1
Section sec_5.1.1
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
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
Section sec_5.11
Section sec_5.11.1
Section sec_5.11.2
Section sec_5.12
Section sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
Section sec_6.1.3
Section sec_6.1.4
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
Table tab_1
Section sec_6.2.3.3
Section sec_6.2.3.4
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
Section sec_6.2.4.4
Section sec_6.3
Section sec_6.3.1
Section sec_6.3.2
Section sec_6.3.3
Section sec_6.3.4
Section sec_6.3.5
Table tab_3
Section sec_6.3.6
Section sec_6.3.7
Section sec_6.3.7.1
Section sec_6.3.7.2
Table tab_a
Figure fig_1
Table tab_b
Figure fig_2
Section sec_6.3.7.3
Section sec_6.3.7.4
Table tab_4
Table tab_5
Table tab_6
Section sec_6.4
Section sec_6.4.1
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
Section sec_6.4.3.4
Section sec_6.4.3.5
Section sec_6.4.4
Section sec_6.4.4.1
Section sec_6.4.4.2
Section sec_6.4.4.3
Section sec_6.4.4.4
Section sec_6.4.4.5
Section sec_6.5
Section sec_6.5.1
Section sec_6.5.2
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_8.3
Section sec_8.4
Section sec_8.5
Section sec_8.6
Section sec_8.7
Section sec_8.7.1
Section sec_8.7.2
Section sec_8.8
Section sec_8.8.1
Section sec_8.8.2
Section sec_8.8.3
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_B
Figure fig_B.1
Annex sec_C
Annex sec_C.1
Annex sec_C.2
Annex sec_C.3
Annex sec_C.4
Table tab_C.1
Table tab_e
Figure fig_C.1
Table tab_f
Figure fig_C.2
Table tab_C.2
Annex sec_C.5
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
Reference ref_19
Reference ref_20
Annex C (informative) Rationale for the analytical performance requirements
Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design and development
4.1 General requirements
4.2 Metrological traceability
4.3 Safety and risk management
4.4 Ergonomics and human factors
4.5 User verification requirements
5 Safety and reliability testing
5.1 General requirements
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
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
5.11 Equipment temperature exposure limits for storage
5.12 Equipment humidity exposure limits for storage
6 Analytical performance evaluation
6.1 General requirements
6.2 Measurement precision
6.3 System accuracy
6.4 Influence quantities
6.5 Stability of reagents and materials
7 Information supplied by the manufacturer
7.1 General requirements
7.2 Performance characteristics
7.3 Options for supplying instructions for use
8 User performance evaluation
8.1 General requirements
8.2 Acceptance criteria and evaluation of results
8.3 Selection and preparation of subjects
8.4 Execution of study protocol
8.5 Glucose reference values
8.6 Human factors
8.7 Data analysis and presentation of results
8.8 Evaluation of instructions for use
Annex A (informative) Possible interfering substances
Annex B (informative) Traceability chain
Annex C (informative) Rationale for the analytical performance requirements
Bibliography