This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.This document applies to— dialysis fluids used for haemodialysis and haemodiafiltration,— substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluidThis document does not apply to— the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid— 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.The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.
This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.
This document applies to
— dialysis fluids used for haemodialysis and haemodiafiltration,
— substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid
This document does not apply to
— the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid
— 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.
The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.
This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. This document 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. 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 this document.
This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. This document 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. 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 this document.
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