BS EN ISO 13959:2015

European foreword
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Dialysis water requirements
4 Tests for compliance with microbiological
  and chemical requirements
Annex A (informative) - Rationale for the
        development and provisions of this
        International Standard
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive
         93/42/EEC on medical devices

Defines minimum requirements for water to be used in haemodialysis and related therapies.

This International Standard specifies minimum requirements for water to be used in haemodialysis and related therapies.

This International Standard includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.

The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are excluded from this International Standard. Those operations are the sole responsibility of dialysis professionals. This International Standard does not apply to dialysis fluid regenerating systems.