• DIN EN ISO 23500 E : 2015

    Current The latest, up-to-date edition.

    GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2015

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

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

    National foreword
    National Annex NA (informative) - Bibliography
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Summary of quality requirements of ISO 13958,
       ISO 13959 and ISO 11663
    5 Critical aspects of system design
    6 Validation of system performance
    7 Quality management
    8 Strategies for microbiological control
    9 Environment
    10 Personnel
    Annex A (informative) - Rationale for the development
            and provisions of this International Standard
    Annex B (informative) - Equipment
    Annex C (informative) - Monitoring guidelines for water
            treatment equipment, distribution systems, and
            dialysis fluid
    Annex D (informative) - Strategies for microbiological
            control
    Annex E (informative) - Validation
    Annex F (informative) - Special considerations for
            home haemodialysis
    Annex G (informative) - Special considerations for
            acute haemodialysis
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration.

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

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

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

    DIN EN ISO 13958:2016-03 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
    DIN EN ISO 13959:2016-03 WATER FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13959:2014)
    ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
    DIN EN 60601-2-16 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT (IEC 60601-2-16:2012)
    DIN EN ISO 26722:2016-02 WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES (ISO 26722:2014)
    ISO 13958:2014 Concentrates for haemodialysis and related therapies
    DIN EN ISO 11663:2016-02 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
    ISO 26722:2014 Water treatment equipment for haemodialysis applications and related therapies
    ISO 13959:2014 Water for haemodialysis and related therapies
    DIN EN 60529 : 2014-09 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529:1989 + A1:1999 + A2:2013)
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