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  • CSA Z23500 : 2016

    Current The latest, up-to-date edition.

    GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES

    Available format(s):  Hardcopy, PDF

    Language(s):  French, English

    Published date:  01-01-2016

    Publisher:  Canadian Standards Association

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

    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)

    Specifies 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 Canadian Standards Association
    Status Current
    Supersedes

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

    Z364.6-17 Quality management for kidney dialysis providers
    CSA Z364.2.1:2013 MONITORING SYSTEMS FOR HEMODIALYSIS EQUIPMENT
    Z364.2.1-13 (R2018) Monitoring systems for hemodialysis equipment

    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
    Z364.5-17 Safe installation and operation of hemodialysis and peritoneal dialysis in a home setting
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