ISO 23500 (International Organization for Standardization)

Current Requirements for Water Treatment Facilities for Haemodialysis

ISO 23500:2011

Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

The international standard ISO 23500 was published in 2011 and is meant especially for dialysis operators. It lines out requirements and control methods for hygienic safety and functionality of a water treatment facility for haemodialysis.

The standard refers to various standards on the quality of fluids in haemodialysis and compiles those requirements and recommendations.

In addition, a validation process for dialysis centers is introduced that can be applied to newly built or modified dialysis centers as well as for existing facilities.

The main topics of the validation process are:

  • creating a validation plan
  • specifying system parameters
  • controlling microbiological quality of dialysis water and dialysis fluid
  • controlling chemical quality of dialysis water and feed water
  • monitoring of system parameters

A validation process that implemented and carried out successfully supports the avoidance of many hygienic risks in dialysis operation by identifying and controlling problems in advance.

Monitoring and service activities allow early detection of critical trends that might compromise safety and functionality of the system and lead to correction in good time – without posing a risk to patients or operation.

Terms and definitions (Source: ISO 23500:2011, 3. Terms and Definitions)

Dialysis Water: Permeate from the water treatment process; quality according to ISO 13959; used for the preparation of dialysis fluid

Dialysis Fluid: Solution made from dialysis water and dialysis concentrates in the dialysis machine; used for exchanging solutes with blood in the dialyser