• AAMI ISO 23500 : 2011

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-09-2014

    Language(s):  English

    Published date:  01-01-2011

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of US adoption of ISO 23500:2011
    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
                            hemodialysis
    Annex G (informative) - Special considerations for
                            acute hemodialysis
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives dialysis practitioners with guidance on the preparation of dialysis fluid for hemodialysis and related therapies and substitution fluid for use in online therapies, such as hemodiafiltration and hemofiltration.

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

    Committee WG 05
    Development Note Supersedes AAMI RD52. (06/2011)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

    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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