AAMI ISO 23500-2:2019 pdf download – Preparation and quality management of fluids for haemodialysis and related therapies
4.1.1 General
The requirements contained in this document apply to the dialysis water as it enters the equipment used to prepare concentrates from powder or other concentrated media at a dialysis facility, to prepare dialysis fluid, or to reprocess dialysers. As such, these requirements apply to the water treatment system as a whole and not to each of the individual devices that make up the system. However, collectively, the individual devices shall produce dialysis water that, at a minimum, meets the requirements of the clause.
4.1.2 Chemical contaminant requirements
Dialysis water used to prepare dialysis fluid or concentrates from powder at a dialysis facility, or to reprocess dialysers for multiple uses, shall not contain chemical contaminants at concentrations in excess of those in ISO 23500-3:2019, Tables 1 and 2 (reproduced as Tables B.1 and B.2). The manufacturer or supplier of a complete water treatment system shall recommend a system capable of meeting the requirements of this clause based on the analysis of the feed water. The system design should reflect possible seasonal variations in feed water quality. The manufacturer or supplier of a complete water treatment and distribution system shall demonstrate that the complete water treatment, storage, and distribution system is capable of meeting the requirements of this document at the time of installation. NOTE 1 If the manufacturer or supplier does not install the water storage and distribution system, then the responsibility of the manufacturer or supplier is limited to demonstrating that the water treatment system, excluding the water storage and distribution system, meets the requirements of this document. If individual devices of the water treatment system are provided by different manufacturers or suppliers, the person or organization specifying the devices is responsible for demonstrating that the complete system meets the requirements of this document at the time of installation.
4.1.3 Organic Carbon, pesticides and other chemicals
The presence of organic compounds, such as pesticides, polycyclic aromatic hydrocarbons and other chemicals such as pharmaceutical products and endocrine disruptors in respect of hemodialysis patients are difficult to define. Consequences of exposure are probably of a long-term nature and it is technically difficult and costly to measure these substances on a routine basis. 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 possible to currently define limits for their presence in water used in the preparation of dialysis fluid. Nanofiltration and reverse osmosis are capable of significant rejection of many such compounds. Granular Activated Carbon (GAC) is also highly effective at removing majority of such compounds. However, as Granular Activated Carbon is widely used in the removal of chlorine/chloramine, their use in the removal of organic carbons, pesticides and other chemicals will be dependent upon the size of the carbon filters and/or beds and users shall be aware of appropriate dimensioning since the majority of carbon valences might be already occupied and not available for further removal activity.