This Standard was developed as a replacement for the overall standard for dialysis RD5. In 2001, AAMI released the first version of RD62 water for dialysis and then again in 2006. Since then this has become a standard followed by many dialysis providers and is recognized throughout the world. This standard, although addressed to industry, has been adopted by most dialysis facilities.
Designed to cover devices used to treat water for hemodialysis, this Standard includes water used for any dialysis process including water for concentrate preparation, water for dialysate, and water for reprocessing dialyzers. It comprises not only water treatment equipment requirements, but also product water quality and labeling and documentation requirements. Obligations for testing are detailed so that providers can ensure quality while remaining compliant.
The most important part of this Standard is the level of contamination allowed. A table shows the maximum levels of chemical contaminants that may be present in the dialysis water. These contaminants should be checked at least yearly to assure the proper function of the water system. The level of contamination is based on the allowable contamination in drinking water specified by the EPA. Since the water will come in contact with the dialysis membrane, the level was reduced to one-tenth the EPA level for drinking water.
In addition to chemical contaminants, the Standard gives the maximum microbial contamination. The levels have been set at 200 CFU/ml with an action limit of 50 CFU/ml. The action limit is the level of contamination at which action should be taken to prevent further degradation of the system. Thus, if testing shows a bacterial count of 50 CFU/ml, action such as disinfection of the system, should be performed.
RD62 also requires that the pyrogens be checked in the system. The pyrogenic material levels have been set at 2 EU/ml with an action limit of 1 EU/ml. Both the bacterial and pyrogen levels should be tested monthly.
In the last section, rationale for the development and provisions of this Standard is given as an historical perspective as well as additional background information into the industry, various committees, key contributors, and further water equipment explanations.