ISO 13958:2002
Concentrates for haemodialysis and related therapies
This International Standard is applicable to dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or haemodiafiltration. It addresses chemical quality and purity, microbial contamination, handling, measurement and labelling of concentrates, the requirements for containers and the tests to monitor concentrates.
This International Standard does not address the final mixing and use of these concentrates and treated water in such therapies. That operation is the sole responsibility of dialysis professionals.
This International Standard is not applicable to dialysing-fluid regeneration systems.
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TitlePage - Concentrates for haemodialysis and related therapies
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative reference
Clause1 - 4 Requirements
Subclause2 - 4.1 Solute concentrations
Subclause2 - 4.2 Water quality
Subclause2 - 4.3 Acidity or alkalinity
Subclause2 - 4.4 Chemical grade
Subclause2 - 4.5 Filtration
Subclause2 - 4.6 Containers
Subclause2 - 4.7 Non-pyrogenicity
Subclause2 - 4.8 Sterility
Clause1 - 5 Labelling and documentation requirements
Subclause2 - 5.1 General requirements
Subclause2 - 5.2 Liquid concentrate
Subclause2 - 5.3 Dry concentrate
Subclause2 - 5.4 Colour coding
Clause1 - 6 Testing of concentrates
Subclause2 - 6.1 General
Subclause2 - 6.2 Solute concentrations
Subclause2 - 6.3 Water quality
Subclause2 - 6.4 Acidity or alkalinity
Subclause2 - 6.5 Chemical grade
Subclause2 - 6.6 Filtration
Subclause2 - 6.7 Containers
Subclause2 - 6.8 Non-pyrogenicity
Subclause2 - 6.9 Sterility
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TitlePage - Concentrates for haemodialysis and related therapies
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative reference
Clause1 - 4 Requirements
Subclause2 - 4.1 Solute concentrations
Subclause2 - 4.2 Water quality
Subclause2 - 4.3 Acidity or alkalinity
Subclause2 - 4.4 Chemical grade
Subclause2 - 4.5 Filtration
Subclause2 - 4.6 Containers
Subclause2 - 4.7 Non-pyrogenicity
Subclause2 - 4.8 Sterility
Clause1 - 5 Labelling and documentation requirements
Subclause2 - 5.1 General requirements
Subclause2 - 5.2 Liquid concentrate
Subclause2 - 5.3 Dry concentrate
Subclause2 - 5.4 Colour coding
Clause1 - 6 Testing of concentrates
Subclause2 - 6.1 General
Subclause2 - 6.2 Solute concentrations
Subclause2 - 6.3 Water quality
Subclause2 - 6.4 Acidity or alkalinity
Subclause2 - 6.5 Chemical grade
Subclause2 - 6.6 Filtration
Subclause2 - 6.7 Containers
Subclause2 - 6.8 Non-pyrogenicity
Subclause2 - 6.9 Sterility