What is ISO 23500-5- Quality of dialysis fluid for haemodialysis and related therapies about?
ISO 23500 discusses the preparation and quality management of fluids for haemodialysis and related therapies. ISO 23500-5 is an international standard that provides for quality of dialysis fluid for haemodialysis and related therapies.
ISO 23500-5 is the fifth part of a multi-part series that lays out minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.
ISO 23500-5 ensures that the dialysis fluid is correctly formulated and meets the applicable quality standards.
ISO 23500-5 includes dialysis fluids used for haemodialysis and hemodiafiltration, including substitution fluid for hemodiafiltration and hemofiltration.
Note 1: ISO 23500-5 excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.
Note 2: Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from ISO 23500-5.
Who is ISO 23500-5- Quality of dialysis fluid for haemodialysis and related therapies for?
ISO 23500-5 on dialysis fluid for haemodialysis and related therapies is useful for:
- Quality management teams for haemodialysis and related therapies
- Hospitals
- Medical laboratories
Why should you use ISO 23500-5- Quality of dialysis fluid for haemodialysis and related therapies?
Haemodialysis patients are directly exposed to large volumes of dialysis fluid, with the dialyser membrane being the only barrier against the transfer of hazardous contaminants from the dialysis fluid to the patient. It has long been known that there could be hazardous contaminants in the water and concentrates used to prepare the dialysis fluid. Therefore, ISO 23500-5 lays out minimum quality requirements for these fluids.
ISO 23500-5 guideline provides data on microbiological contaminants in dialysis fluid, for standard dialysis fluid, for ultrapure dialysis fluid, and for online prepared substitution fluid for haemodialysis and related therapies. ISO 23500-5 also provides detailed test methods for dialysis fluid for haemodialysis and related therapies. This helps in the proper assessment that provides reliable results for dialysis fluid for haemodialysis and related therapies that can be reproduced in any laboratory.
In addition, it assists in meeting the applicable quality standards for dialysis fluid for haemodialysis.
