Standard
[WITHDRAWN]
ISO 23500-4:2019-02
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
German title
Herstellung und Qualitätsmanagement von Flüssigkeiten für die Hämodialyse und verwandte Therapien - Teil 4: Konzentrate für die Hämodialyse und verwandte Therapien
Publication date
2019-02
Original language
English
Pages
22
Publication date
2019-02
Original language
English
Pages
22
Product information on this site:
Quick delivery via download or delivery service
Buy securely with a credit card or pay upon receipt of invoice
All transactions are encrypted
Content
Content (en)
Foreword
Introduction
Scope
Normative references
Terms and definitions
Requirements
Show subsection Close subsection Concentrates
Show subsection Close subsection Physical state
Show subsection Close subsection Liquid solute concentrations
Solute concentrations based on powder
Water
Bacteriology of concentrates
Show subsection Close subsection Bacteriology of acid concentrates
Bacteriology of bicarbonate concentrates
Endotoxin levels
Fill quantity
Chemical grade
Particulates
Additives — “Spikes”
Containers
Bulk-delivered concentrate
Concentrate generators
Manufacturing equipment
Systems for bulk mixing concentrate at a dialysis facility
Show subsection Close subsection General
Materials compatibility
Disinfection protection
Show subsection Close subsection Safety requirements
Bulk storage tanks
Ultraviolet irradiators
Piping systems
Electrical safety requirements
Tests
Show subsection Close subsection General
Concentrates
Show subsection Close subsection Physical state
Solute concentrations
Show subsection Close subsection Liquid solute concentrations
Solute concentrations from powder
Water
Microbial contaminant test methods for bicarbonate concentrates
Endotoxin levels
Fill quantity
Chemical grade
Particulates
Additives — “Spikes”
Containers
Bulk delivered concentrate
Concentrate generators
Manufacturing equipment
Systems for mixing concentrate at a dialysis facility
Show subsection Close subsection General
Materials compatibility
Disinfection protection
Show subsection Close subsection Safety requirements
Bulk storage tanks
Ultraviolet irradiators
Piping systems
Electrical safety requirements
Labelling
Show subsection Close subsection General
General labelling requirements for concentrates
Labelling requirements for liquid concentrate
Labelling requirements for powder concentrate
Additives
Labelling requirements for concentrate generators
Labelling for concentrate mixer systems
Show subsection Close subsection General
Product literature for concentrate mixers
Rationale for the development and provisions of this document (informative)
Show subsection Close subsection Scope
Requirements
Show subsection Close subsection General
Show subsection Close subsection Overview
Physical state
Solute concentrations
Water
Microbiology of bicarbonate concentrates
Fill quantity
Chemical grade
Additives — “Spikes”
Containers
Endotoxin levels
Bulk delivery concentrate
Concentrate generator systems
Manufacturing equipment
Show subsection Close subsection Labelling
Show subsection Close subsection General
Labelling requirements for liquid concentrate
Labelling requirements for powder concentrate
Bibliography
Cooperation at DIN
Please get in touch with the relevant contact person at DIN if you have problems understanding the content of the standard or need advice on how to apply it.
Loading recommended items...
Loading recommended items...
Loading recommended items...
Loading recommended items...