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  • BSI
    BS EN ISO 23500-1:2024 Preparation and quality management of fluids for haemodialysis and related therapies - General requirements
    Edition: 2024
    $569.57
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Description of BS EN ISO 23500-1:2024 2024

This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document. This document is applicable to —     the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused. —     the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and —     the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates. This document does not apply to —     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. This document does not address clinical issues associated with inappropriate usage of such fluids.

Standard NumberBS EN ISO 23500-1:2024
TitlePreparation and quality management of fluids for haemodialysis and related therapies - General requirements
StatusDefinitive
Publication Date2024-09-09
ReplacesBS EN ISO 23500-1:2019
Identical National Standard OfEN ISO 23500-1, ISO 23500-1:2024
DescriptorsMedical equipment, Quality management, Concentrates, Quality control, Dialysis, Impurities, Water, Solutes, Purity, Blood, Water purification, Artificial kidneys, Chemical composition, Microbiology, Fluids, Contamination
ICS11.040.20 Transfusion, infusion and injection equipment, 11.040.40 Implants for surgery, prosthetics and orthotics, 11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/2
ISBN978 0 539 20657 9
PublisherBSI
Pages116

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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