BS EN ISO 23500-4:2019

What is BS EN ISO 23500‑4- Concentrates for haemodialysis and related therapies about?  

BS EN ISO 23500‑4 is the fourth part of the multi-series standard on the preparation and quality management of fluids for haemodialysis and related therapies that outlines Concentrates for haemodialysis and related therapies. 

BS EN ISO 23500‑4 specifies minimum requirements for concentrates used for haemodialysis and related therapies. And is addressed to the manufacturer of such concentrates. In several instances, the dialysis fluid is addressed, which is made by the end-user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer. 

BS EN ISO 23500‑4 includes concentrates in both liquid and powder forms. It also includes additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. 

NOTE- 

haemodialysis equipment, which is addressed in IEC 60601-2-16:2012 is not covered in BS EN ISO 23500‑4 

Who is BS EN ISO 23500‑4- Concentrates for haemodialysis and related therapies for? 

BS EN ISO 23500‑4 is applicable to- 

• Manufacturers and suppliers of Concentrates for haemodialysis and related therapies 
• Hospitals 

Why should you use BS EN ISO 23500‑4- Concentrates for haemodialysis and related therapies? 

Requirements and goals established by BS EN ISO 23500‑4 will help ensure the effective, safe performance of haemodialysis concentrates and related materials. 

BS EN ISO 23500‑4 provides you guidance on the labelling requirements and minimum requirements for manufacturing Concentrates for haemodialysis, so that expected quality standards are achieved.  

What’s changed since the last update? 

BS EN ISO 23500‑4:2019 supersedes ISO 23500‑4:2014, which has been withdrawn. BS EN ISO 23500‑4:2019 has some technical changes with respect to ISO 23500‑4:2014, these includes: 

• The document forms part of a revised and renumbered series dealing with the preparation and quality management of fluids for haemodialysis and related therapies. The series comprises ISO 23500‑1 (previously ISO 23500), ISO 23500‑2, (previously ISO 26722), ISO 23500‑3, (previously ISO 13959), ISO 23500‑4, (previously ISO 13958), and ISO 23500‑5, (previously ISO 11663).