ISO 23500-3:2019 pdf free.Preparation and quality management of fluids for haemodialysis and related therapies -Water for haemodialysis and related therapies.
4 Requirements 4.1 Dialysis water quality requirements
The quality of the dialysis water, as specified in 4.2 and 4.3, shall be verified upon installation of a water treatment system. Regular surveillance of the dialysis water quality shall be 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. If the water supply is derived from an alternate source such as a privately-owned borehole or well, contaminant levels cannot be as rigorously controlled.
4.2.1 General
Dialysis water shall not contain chemicals at concentrations in excess of those listed in Tables 1 and 2.. or as required by national legislation or regulations. Table 1 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 on a routine basis. The effect of their presence on haemodialysis patients is (lifficult 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.
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 these chemicals. However, as Granular Activated Carbon is widely used in the removal chlorine/chloramine, their use in the removal or 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 can be already occupied and not available for further removal activity.
NOTE 1 See A for an explanation of values supplied.
NOTE 2 The maximum allowable levels of contaminants listed in Tables 1 and 2 include the anticipated uncertainty associated with the analytical methodologies listed in Table 4.
Where the dialysis water is used for the reprocessing of haemodialysers (cleaning, testing, and mixing of disinfectants), the user is cautioned that the dialysis water shall meet the requirements of this document. The dialysis water should be measured at the input to the dialyser reprocessing equipment.
4.2.2 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 haemodialysis 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 at present not possible to define limits for their presence in water used in the preparation of dialysis fluid.
4.3 Dialysis water microbiological requirements
Total viable microbial counts in dialysis water shall be less than 100 CFU/ml, or lower if required by national legislation or regulations. An action level shall be set based on knowledge of the microbial dynamics of the system. Typically, the action level will be 50 % of the maximum allowable level.
Endotoxin content in dialysis water shall be less than 0,25 EU/mI, or lower if required by national legislation or regulations. An action level shall be set, typically at 50 % of the maximum allowable level.ISO 23500-3 pdf download.