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    I.S. EN ISO 23500:2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014)

    Available format(s):  Hardcopy, PDF

    Superseded date:  12-04-2019

    Language(s):  English

    Published date:  01-01-2015

    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)

    National Foreword
    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 National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 13958:2014 Concentrates for haemodialysis and related therapies
    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
    ISO 26722:2014 Water treatment equipment for haemodialysis applications and related therapies
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ISO 13959:2014 Water for haemodialysis and related therapies
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