• SN EN 13867 : 2002 + A1 2009

    Current The latest, up-to-date edition.

    CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES

    Available format(s): 

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Swiss Standards

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    Table of Contents - (Show below) - (Hide below)

    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 concrete 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) Clauses of this European Standard
             addressing Essential Requirements or other
             provisions of EU Directives
    Annex ZB (informative) A-deviations
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. Addresses chemical and microbiological quality and purity, handling and labeling of concentrates.

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    Development Note 2002 Edition Re-issued in November 2009 & incorporates AMD 1 2009. (12/2009)
    Document Type Standard
    Publisher Swiss Standards
    Status Current
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