Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design and development
4.1 General requirements
4.2 Safety
4.3 Traceability
4.4 Ergonomic/human factor aspects
4.5 Risk analysis
4.6 User verification
5 Information supplied by the manufacturer
5.1 Labels for the blood-glucose meter
5.2 Instructions for use for the blood-glucose monitoring
system
5.3 Labels for the reagent system and control material
5.4 Instructions for use for reagents and control material
6 Safety and reliability testing
6.1 General requirements
6.2 Protection against electric shock
6.3 Protection against mechanical hazards
6.4 Electromagnetic compatibility
6.5 Resistance to heat
6.6 Resistance to moisture and liquids
6.7 Protection against liberated gases, explosion and
implosion
6.8 Meter components
6.9 Performance test
6.10 Mechanical resistance to shock, vibration and impact
6.11 Equipment temperature exposure limits
6.12 Equipment humidity exposure test protocol
6.13 Reagent storage and use testing
7 Analytical performance evaluation
7.1 General requirements
7.2 Precision evaluation
7.3 System accuracy evaluation
7.4 Minimum acceptable system accuracy
8 User performance evaluation
8.1 General
8.2 Evaluation sites
8.3 User evaluation
8.4 Evaluation for instructions for use
Annex A (normative) Additional requirements for electromagnetic
compatibility
Annex B (informative) Traceability chain
Bibliography