International Standard
ISO 23500-1:2024
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
Reference number
ISO 23500-1:2024
Edition 2
2024-08
Read sample
ISO 23500-1:2024
84368
Published (Edition 2, 2024)

ISO 23500-1:2024

ISO 23500-1:2024
84368
Language
Format
CHF 216
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Abstract

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.

General information

  •  : Published
     : 2024-08
    : International Standard published [60.60]
  •  : 2
     : 104
  • ISO/TC 150/SC 2
    11.040.40 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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