Dialysis - Related International Standards
The following non-harmonised international standards are related to Dialysis for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-39:2024 | Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment | active | 14, 14.2 | Link |
| IEC 60601-2-16:2025 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment | active | 1, 3, 5, 9, 14 | Link |
| ISO 23500-1:2024 | Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements | active | 1, 3, 5, 10 | Link |
| ISO 23500-3:2024 | Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies | active | 1, 3, 5, 10 | Link |
| ISO 23500-5:2024 | Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies | active | 1, 3, 5, 10 | Link |
| ISO 8637-1:2024 | Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators | active | 1, 3, 5, 10, 11 | Link |