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

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Publication date: 2019-02
Original language: English
Pages: 22

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Content
ICS
Replacement amendments
Cooperation at DIN

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Content

Content (en)

Foreword
Introduction
Scope
Normative references
Terms and definitions
Requirements
- Concentrates
  - Physical state
  - Water
  - Bacteriology of 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
  - General
  - Materials compatibility
  - Disinfection protection
  - Safety requirements
  - Bulk storage tanks
  - Ultraviolet irradiators
  - Piping systems
  - Electrical safety requirements
Tests
- General
- Concentrates
  - Physical state
  - Solute concentrations
  - 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
  - General
  - Materials compatibility
  - Disinfection protection
  - Safety requirements
  - Bulk storage tanks
  - Ultraviolet irradiators
  - Piping systems
  - Electrical safety requirements
Labelling
- 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
  - General
  - Product literature for concentrate mixers
Rationale for the development and provisions of this document (informative)
- Scope
- Requirements
  - General
  - Manufacturing equipment
- Labelling
  - General
  - Labelling requirements for liquid concentrate
  - Labelling requirements for powder concentrate
Bibliography

ICS

11.040.40

Replacement amendments

This document replaces ISO 13958:2014-04 .

This document has been replaced by: ISO 23500-4:2024-04 .

Cooperation at DIN

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