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Table 2 Microbiological Quality Standard for Dialysis Fluids in Japan, excerpt from reference [14]

From: The central dialysis fluid delivery system (CDDS): is it specialty in Japan?

Attainment level

 

 Dialysis water (reverse osmosis (RO) water)

 

  Bacteria <100 CFU/ml

 

  Endotoxin <0.050 EU/ml

 

 Standard dialysis fluid

 

  Bacteria <100 CFU/ml

 

  Endotoxin <0.050 EU/ml

 

 Ultrapure dialysis fluid

 

  Bacteria <0.1 CFU/ml

 

  Endotoxin <0.001 EU/ml (less than detection limit)

 

 Online-prepared substitution fluid

 

  Sterile and non-pyrogenic

 

  Bacteria <10–6

 

  Endotoxin <0.001 EU/ml (less than detection limit)

 

Indications for dialysis system based on the quality of dialysis fluids

 

 Standard dialysis fluid

 

  Minimum requirement for dialysis therapy

 

 Ultrapure dialysis fluida

 

  Dialysis fluid for the preparation of online substitution fluid.

 

  Dialysis system for active use of back filtrate

 

  Push and pull HDF system

 

  Internal filtration-enhanced dialysis (IFEHD)

 

 Online-prepared substitution fluid

 

  Online HDF/online hemofiltration

 
  1. aUltrapure dialysis fluid is desirable for all dialysis modalities