ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies一 Part 3: Water for haemodialysis and related therapies.
This document specifies minimum requirements for water to be used in haemodialysis and related therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.
2 Normative references
The following documents are referred to in the text in such a way that some or all 01 their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
Iso 23500-1, Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 23500-1 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
4.1 Dialysis water quality requirements
The quality of the dialysis water, as specified in 4.2 and ‘L3, shall he verified upon installation of a water treatment system. Regular surveillance of the dialysis water quality shall he carried out thereafter.
NOTE Throughout this document it is assumed that the water undergoing treatment is potable water and therefore meets the appropriate regulatory requirements for such water. lithe water supply is derived from an alternate source such as a privately-owned borehole or well, contaminant levels cannot be as rigorously controlled.
4.2 Chemical contaminant requirements
Dialysis water shall not contain chemicals at concentrations in excess of those listed in Tables I and 2 or as required by national legislation or regulations. Tab1ei does not include any recommendation in respect of organic carbon, pesticides and other chemicals such as pharmaceutical products and endocrine disruptors that can he present in feed water. It is technically difficult and costly to measure such substances oii a routine basis. The effect of their presence on hacrnodialysis patients is difficult to define and consequences of exposure are probably of a long-term nature. Furthermore, there is an absence of evidence of their widespread presence in water although it is recognized that inadvertent discharges are possible. In view of this, it is not at present possible to define limits for their presence in water used in the preparation of dialysis fluid.ISO 23500-3 pdf download.