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  • DIN EN 13867:2009-09

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-03-2016

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Vorwort
    Einleitung
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Anforderungen
      4.1 Konzentrationsgrenzen
      4.2 Wasserqualität
      4.3 pH-Bereich
      4.4 Qualität der verwendeten Chemikalien
      4.5 Herstellungsverfahren (Filtration)
      4.6 Behälter
      4.7 Mikrobiologische Qualität
    5 Anforderungen an die Kennzeichnung und
      Dokumentation
      5.1 Allgemeines
      5.2 Auf dem Konzentrat-Behälter anzugebende
          Informationen
      5.3 Auf einer eventuellen Versandverpackung
          anzugebende Informationen
      5.4 In den Begleitunterlagen anzugebende
          Informationen
      5.5 Farbkodierung
    6 Prüfverfahren
      6.1 Wasserqualität
      6.2 pH-Wert
      6.3 Herstellungsverfahren (Filtration)
      6.4 Behälter
      6.5 Mikrobiologische Qualität
      6.6 Sterilität
    Anhang A (informativ) Beispiele für
              Analyseverfahren
    Anhang ZA (informativ) Zusammenhang zwischen
              dieser Europäischen Norm und den grundlegenden
              Anforderungen der EG-Richtlinie 93/42/EWG
    Anhang ZB (informativ) A-Abweichungen
    Literaturhinweise

    Abstract - (Show below) - (Hide below)

    Defines requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    EN 1174-3 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES
    EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
    IEC 60601-2-16 : 4.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    EN 1174-2 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE
    EN 980:2008 Symbols for use in the labelling of medical devices
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