DIN EN ISO 23500 E : 2015
Current
The latest, up-to-date edition.
GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014)
Hardcopy , PDF
English
01-01-2015
National foreword
National Annex NA (informative) - Bibliography
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
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