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
Annexes
A (informative) - Rationale for the development
and provisions of this International Standard
B (informative) - Equipment
C (informative) - Monitoring guidelines for water
treatment equipment, distribution systems, and
dialysis fluid
D (informative) - Strategies for microbiological
control
E (informative) - Validation
F (informative) - Special considerations for home
haemodialysis
G (informative) - Special considerations for acute
haemodialysis
Bibliography