AAMI ISO 23500-1:2019 pdf download – Preparation and quality management of fluids for haemodialysis and related therapies
1.1 General
This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice. This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies. The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments.
4.2.1 General
The requirements contained in this clause apply to dialysis water at its point of use. As such, these requirements apply to the water treatment system as a whole and not to each of the devices that make up the system. However, collectively, the individual devices shall produce water that, at a minimum, meets the requirements of this clause.
4.2.2 Chemical contaminants in dialysis water
Dialysis water shall not contain substances at levels greater than those listed in Tables 1 and 2. The manufacturer or supplier of a complete water treatment system should recommend a system that is capable of meeting these requirements based on a feed water analysis. The system design should reflect possible seasonal variations in feed- water quality. The manufacturer or supplier of a complete water treatment and distribution system should demonstrate that the complete water treatment, storage, and distribution system is capable of meeting the requirements of ISO 23500-3 at the time of installation. NOTE 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 of ISO 23500-3:2019. Other analytical methods can be used, provided that such methods have been appropriately validated and are comparable to the cited methods. Following installation of a water treatment, storage, and distribution system, the user is responsible for regular surveillance of the levels of chemical contaminants in the dialysis water and for complying with the requirements of this document.
No limits in respect of organic compounds are included in the above table. Currently, there is limited documentary evidence to suggest that exposure impacts on patients’ wellbeing. A suggested starting point to establish whether such compounds are of concern is the National Drinking Water requirement for organic compounds. Since organic compounds can be effectively removed by the use of activated carbon beds or filters, the dialysis facility should consider carefully their dimensioning to ensure that there is sufficient capacity to remove organic compounds should the need arise.