Standards on Haemodialysis and haemodiafiltration
European standards and international standards for haemodialysis, haemodiafiltration, haemodiafiltration equipment, fluids for haemodialysis
European standards and international standards for haemodialysis, haemodiafiltration, haemodiafiltration equipment, fluids for haemodialysis
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024)
60.60 Standard published
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024)
60.60 Standard published
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
90.92 Standard to be revised
Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies
95.99 Withdrawal of Standard
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)
60.60 Standard published
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
90.92 Standard to be revised
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024)
60.60 Standard published
Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
90.92 Standard to be revised
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
60.60 Standard published
Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies
90.92 Standard to be revised
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
60.60 Standard published
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
60.60 Standard published
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
90.92 Standard to be revised
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
90.92 Standard to be revised
Extracorporeal systems for blood purification — Part 3: Plasmafilters
90.92 Standard to be revised
Guideline for safe operation of medical equipment used for haemodialysis treatments
60.60 Standard published
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
60.60 Standard published
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
60.60 Standard published
European and International standards for haemodialysis, haemodiafiltration, haemodiafiltration equipment, fluids for haemodialysis.
Haemodialysis and haemodiafiltration are critical procedures in treating renal disease, preserving the health and quality of life for patients with kidney failure. These procedures, performed by specialized equipment, require high-standard fluids and materials to ensure safety, efficiency, and efficacy.
Internationally, both the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) contribute to setting these standards. They propagate these guidelines to maintain consistency and safety across different geographical regions, healthcare systems, and technological platforms.
ISO provides a comprehensive set of guidelines for both haemodialysis and haemodiafiltration. These guidelines aim to ensure product safety, performance, and compatibility. They include standards for haemodialysis equipment, governing everything from the design and manufacturing processes to evaluation methods and safety requirements.
Similarly, the standards for the fluids used in these processes are also rigorously defined. They cover key factors such as purity, chemical composition, and sterility. The standards ensure the fluids are safe for patient use, as well as compatible with the materials and systems used in haemodialysis and haemodiafiltration equipment.
Parallelly, IEC focuses on the electrical safety and electromagnetic compatibility of the haemodialysis and haemodiafiltration equipment. IEC's standards address potential hazards stemming from electricity and electromagnetic fields, ensuring the equipment is safe and reliable.
In conclusion, all these standards support the development, verification, and validation of safe and effective haemodialysis and haemodiafiltration procedures. By adhering to these standards, healthcare providers can help ensure the safety and well-being of their patients, while manufacturers can ensure their products are reliable, effective, and market-ready.
The European standardization bodies, CEN and CENELEC, adopt these standards at European level, using them for the harmonization of requirements in Europe and in support of EU Medical Devices legislation.