EN ISO 23500:2015

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of quality requirements of ISO 13958,
   ISO 13959 and ISO 11663
5 Critical aspects of system design
6 Validation of system performance
7 Quality management
8 Strategies for microbiological control
9 Environment
10 Personnel
Annex A (informative) - Rationale for the
        development and provisions of this
        International Standard
Annex B (informative) - Equipment
Annex C (informative) - Monitoring guidelines
        for water treatment equipment,
        distribution systems, and dialysis fluid
Annex D (informative) - Strategies for microbiological
        control
Annex E (informative) - Validation
Annex F (informative) - Special considerations for
        home haemodialysis
Annex G (informative) - Special considerations for
        acute haemodialysis
Bibliography

ISO 23500:2014 provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, ISO 23500:2014 functions as a recommended practice.ISO 23500:2014 addresses the user's responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of ISO 23500:2014, the dialysis fluid includes dialysis water used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user's facility, as well as concentrates and the final dialysis fluid and substitution fluid.