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  • EN ISO 11663:2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)

    Available format(s): 

    Superseded date:  25-03-2022

    Language(s): 

    Published date:  04-11-2015

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Tests for compliance with microbiological
      requirements
    Annex A (informative) - Rationale for the
            development and provisions of this
            International Standard
    Annex B (informative) - Reference tables from
            ISO 13959
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on medical devices

    Abstract - (Show below) - (Hide below)

    ISO 11663:2014 specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.ISO 11663:2014 includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.

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

    Committee CEN/TC 205
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN EN ISO 13958:2016-03 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
    DIN EN ISO 13958 E : 2016 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)

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

    ISO 13958:2014 Concentrates for haemodialysis and related therapies
    ISO 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
    ISO 13959:2014 Water for haemodialysis and related therapies
    AAMI RD52 : 2004 DIALYSATE FOR HEMODIALYSIS
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