ISO 13958:2002

Concentrates for haemodialysis and related therapies

Scope

This International Standard is applicable to dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or haemodiafiltration. It addresses chemical quality and purity, microbial contamination, handling, measurement and labelling of concentrates, the requirements for containers and the tests to monitor concentrates.
This International Standard does not address the final mixing and use of these concentrates and treated water in such therapies. That operation is the sole responsibility of dialysis professionals.
This International Standard is not applicable to dialysing-fluid regeneration systems.