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  • AAMI TIR72 : 2017

    Current The latest, up-to-date edition.

    DIALYSIS FLUID CHEMICAL COMPOSITION

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  08-09-2017

    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
    Foreword
    Introduction
    1 Scope
    2 Definitions
    3 Rationale for the control of chemical
      composition of dialysis fluid
    4 Strategies to achieve control of chemical
      content in dialysis fluid
    5 Example of dialysis product process flow
      diagram
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the roles of manufacturing, laboratory testing, and clinical processes in relation to the production and testing of dialysis fluid for hemodialysis.

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

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

    AAMI 13959 : 2014 WATER FOR HEMODIALYSIS AND RELATED THERAPIES
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    AAMI 11663 : 2014 QUALITY OF DIALYSIS FLUID FOR HEMODIALYSIS AND RELATED THERAPIES
    AAMI 26722 : 2014 WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS AND RELATED THERAPIES
    AAMI 13958 : 2014 CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES
    ANSI/AAMI/IEC 60601-1-2:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
    AAMI IEC 60601-2-16 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT
    AAMI 23500 : 2014 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES
    ANSI/AAMI/IEC 60601-1-8:2006/A2:2021 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    AAMI RD52 : 2004 DIALYSATE FOR HEMODIALYSIS
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