Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design
4.1 Ergonomic/human factor aspects
4.2 Risk analysis
5 Labelling and documentation
5.1 Blood glucose monitor labels
5.2 User manual for the blood glucose monitoring
system
5.3 Reagent system and control material labels
5.4 Reagents and control material inserts
6 Blood glucose monitor design and interference
aspects
6.1 Protection against electric shock and patient
leakage current
6.2 Protection against mechanical hazards
6.3 Baseline performance test
6.4 Mechanical resistance to shock, vibration,
and impact
6.4.1 Vibration test protocol
6.4.2 Drop test protocol
6.5 Equipment humidity exposure test protocol
6.5.1 High temperature test protocol
6.5.2 Low temperature test protocol
6.6 Resistance to heat
6.7 Resistance to moisture and liquids
6.8 Protection against liberated gases, explosion,
and implosion
6.9 Components
6.10 Equipment humidity exposure test protocol
7 Technical performance evaluation
7.1 Imprecision testing
7.1.1 General
7.1.2 Within run imprecision test protocol
7.1.3 Total imprecision (day-to-day) test
7.1.4 Data presentation
7.2 Accuracy testing
7.2.1 General
7.2.2 Materials/Methods
7.2.3 Run format
7.2.4 Data presentation
7.3 Minimum acceptable performance
8 User performance evaluation
8.1 Selection of user groups
8.2 Selection of evaluation sites
8.3 User instructions
8.4 User techniques
Annex A (informative) Analytical Performance
Requirements for Self-Monitoring of
Blood Glucose for the Contro of Diabetes
Mellitus
A.1 Purpose
A.2 Introduction
A.3 Currently Accepted Performance Criteria
A.4 Current state-of-the-art
A.5 Clinical Studies
A.6 Conclusions
Bibliography