Hemodialysis (AKA haemodialysis) is a proven therapy for renal (kidney) failure, with treatment facilities throughout the world. Now the ISO committee for cardiovascular implants and extracorporeal systems has updated five standards relating to the fluids used in this process. These five ISO hemodialysis standards are each discussed in today’s review. All five updates are technical revisions, so if you rely on these standards, you’ll want the new copies.
ISO 11663, 2nd Edition, Quality of dialysis fluid for haemodialysis and related therapies
Since hemodialysis patients are exposed to a large volume of dialysis fluid, you can see that there’s a risk of contamination from the water and concentrates used to produce the dialysis fluid itself. This standard provides minimum quality requirements for such fluids.
ISO 13958, 3rd Edition, Concentrates for haemodialysis and related therapies
Dialysis fluid is usually mixed at the treatment facility using a concentrate and water. This standard covers concentrates in both liquid and powder form, as well as “spikes,” chemical additives that may be added to the final mix. It is intended to primarily be used by concentrate providers, as well as mixing equipment manufacturers.
ISO 13959, 3rd Edition, Water for haemodialysis and related therapies
As you now understand, water is an essential component of the fluid used in this therapy. You need the assurance of an adequate water supply, and a measure of purity as well. This standard gives you the minimum chemical and microbiological requirements for your water supply. And it covers when and how tests of the water supply should be done as well.
ISO 23500, 2nd Edition, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
Dialysis fluid quality is dependent on good process management for the healthcare workers actually delivering the therapy. So this standard addresses the core principles involved in this activity. First the 3 standards noted above are discussed. Then some of the basics are reviewed: the need to comply with local regulations, realization that the water supply may change from time to time, and so on. Validation is covered — how to assign various responsibilities, determine your parameters, do your testing, etc. Section 7 is a lengthy discussion of quality in all aspects of hemodialysis, while Section 8 addresses microbiological control. Environment and personnel are also included, as well as 7 informative Annexes and a bibliography.
ISO 26722, 2nd Edition, Water treatment equipment for haemodialysis applications and related therapies
This standard is for equipment manufacturers and for the folks that actually specify various configurations for facilities. While it was written with multiple users in mind, it can also be used in situations where there’s only 1 patient (home use). So this standard focuses in on the mechanical aspects of the process — the affect that piping may have on the water supply, and so on. It also reviews such things as the testing of the water and the fluid mixture so that the equipment used can support these types of tests. Marking and product literature are reviewed too.
Anyone who uses these 5 ISO hemodialysis standards will also be pleased by the extensive information found in the Annex section in each. The discussion of the Rationale for each provides you with better understanding of the differences between the U.S. (AAMI standards) and Europe (ISO-based standards). And it defines the concerns that led to this standardization effort as well.
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