YY 0054-2003Haemodialysis, haemodiafiltration and haemofiltration equipment (English PDF)

National Standard of the People's Republic of China

Replacing

YY 0054-1991

Issued by: National Medical Products Administration of the People's Republic of China

Contents

• 1 Scope
• 2 Normative References
• 3 Terms and Definitions
• 4 Classification
• 5 Requirements
• 5.1 Normal working conditions of the equipment
• 5.2 Flow control
• 5.3 Dialysate composition
• 5.4 Filtration-sterilization system
• 5.5 Control and protection of dialysate conductivity
• 5.6 Temperature control
• 5.7 Pressure monitoring
• 5.8 Dialysate flow, temperature and conductivity stability
• 5.9 Blood leakage protection system
• 5.10 Prevent air from entering
• 5.11 PH measuring device
• 5.12 Network power supply interruption
• 5.13 Degassing function
• 5.14 Waste liquid protection
• 5.15 Disinfection
• 5.16 Operating noise
• 5.17 Appearance and structure
• 5.18 Safety requirements
• 5.19 Environmental test
• 6 Test Methods
• 6.1 Test working conditions
• 6.2 Flow control test
• 6.3 Dialysate composition test
• 6.4 Filtration-sterilization system test
• 6.5 Dialysate conductivity control and protection test
• 6.6 Temperature control system test
• 6.7 Pressure monitoring test
• 6.8 Dialysate flow, temperature, conductivity stability test
• 6.9 Blood leakage protection system test
• 6.10 Test to prevent air from entering
• 6.11 PH measuring device test
• 6.12 Network power supply interruption test
• 6.13 Degassing function test
• 6.14 Waste liquid protection test
• 6.15 Disinfection test
• 6.16 Working noise test
• 6.17 Appearance and structural testing
• 6.18 Safety requirements test
• 6.19 Environmental test