AAMI 23500 pdf free download

AAMI 23500 pdf free download.Guidance for the preparation and quality management of fluids for hemodialysis and related therapies.
4.1 Dialysis water
4.1.1 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.
4.1.2 Chemical contaminants in dialysis water
Dialysis water shall not contain substances at levels greater than those listed in ISO 13959 (see 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 13959 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 3 of ISO 13959. Other analytical methods can be used, provided that such methods have been appropriately validated and compared to the cited methods.
Following installation of a water treatment, storage, and distribution system, the user is responsible for regular monitoring of the levels of chemical contaminants in the dialysis water and for complying with the requirements of this International Standard.
4.1.3 Microbiological contaminants in dialysis water
The total viable microbial count and endotoxin concentration in dialysis water shall comply with the maximum allowable levels specified in ISO 13959 (see Table 3). Action levels for the total viable microbial count and endotoxin concentration shall also be set, based on knowledge of the microbial dynamics of the system. Typically, the action level is set at 50 % of the maximum allowable level for bacteria and endotoxins. If a total viable microbial count or endotoxin concentration at or above the action level is observed in the dialysis water, corrective measures should be taken promptly to reduce the level. 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 13959 at the time of installation.
Following installation of a water treatment, storage and distribution system, the user is responsible for regular monitoring of the microbiology of the system and for complying with the requirements of this International Standard, including those requirements related to action levels.
4.3 Requirements for dialysis fluid
4.3.1 General
The requirements contained in this clause apply to a sample of the dialysis fluid collected as close as practicable to the inlet to the dialyzer.
ISO 11663 defines three levels of dialysis fluid: standard dialysis fluid, ultrapure dialysis fluid, and online-prepared substitution fluid. Standard dialysis fluid is considered the minimum acceptable quality for routine hemodialysis. Ultrapure dialysis fluid is recommended for routine hemodialysis.
4.3.2 Microbiological requirements for standard dialysis fluid
The total viable microbial count and endotoxin concentration in standard dialysis fluid shall comply with the maximum allowable levels specified in ISO 11663 and reproduced in Table 4. Action levels for the total viable microbial count and endotoxin concentration shall also be set, based on knowledge of the microbial dynamics of the system as specified in ISO 11663. Typically, the action level is set at 50 % of the maximum allowable level for total viable microbial count and endotoxins. If total viable microbial counts or endotoxin concentrations at or above the action levels are observed in the dialysis fluid, corrective measures, such as disinfection and retesting, should promptly be taken to reduce the levels.AAMI 23500  pdf download.