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