UNI EN 13867 : 2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 Concentration limits
  4.2 Water quality
  4.3 pH range
  4.4 Chemical quality
  4.5 Manufacturing process (filtration)
  4.6 Containers
  4.7 Microbiological quality
5 Labelling and documentation requirements
  5.1 General
  5.2 Information to be given on the concentrate container
  5.3 Information to be given on the shipping container, if any
  5.4 Information to be given in the accompanying documents
  5.5 Colour coding
6 Test methods
  6.1 Water quality
  6.2 pH
  6.3 Manufacturing process (filtration)
  6.4 Containers
  6.5 Microbiological quality
  6.6 Sterility
Annex A (informative) - Examples of analytical methods
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC 'Medical Devices'
Annex ZB (informative) A-deviations
Bibliography

Describes requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. Also applies to chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates.