• I.S. EN 13867:2002

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES

    Available format(s):  Hardcopy, PDF

    Superseded date:  20-12-2015

    Language(s):  English

    Published date:  01-01-2002

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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 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

    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.

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    Development Note 2002 Edition Re-Issued in August 2009 & incorporates AMD 1 2009. (08/2009)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
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