• CSA Z364.2.2 : 2003

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    WATER TREATMENT EQUIPMENT AND WATER QUALITY REQUIREMENTS FOR HEMODIALYSIS

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-07-2013

    Language(s):  English

    Published date:  01-01-2003

    Publisher:  Canadian Standards Association

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

    Preface
    1 Scope
    2 Reference Publications
    3 Definitions
    4 Water Quality
      4.1 Feed Water
      4.2 Product Water
           4.2.1 Microbial Count and Endotoxin Concentration
           4.2.2 Chemical Requirements
    5 Water Treatment Equipment
      5.1 Feed Water
      5.2 Product Water
      5.3 Sanitization of Water Treatment and Distribution Equipment
      5.4 Deionization
      5.5 Electrodialysis
      5.6 Reverse Osmosis
      5.7 Filters and Ultrafilters
      5.8 Carbon Adsorption Media
      5.9 Automatic Water Pre-treatment Devices
      5.10 Storage Tanks
    6 Safety
      6.1 General
      6.2 Electrical Safety
      6.3 Automatic Disinfection
    7 Labelling and Documentation
      7.1 Water Treatment Equipment Labels
      7.2 Operating and Service Manual
      7.3 Records
    8 Tests
      8.1 Tests of Product Water Quality
           8.1.1 Bacteriology
           8.1.2 Inorganics
           8.1.3 Organics
           8.1.4 Pyrogens
      8.2 Compliance with Water Treatment Equipment Requirements
           8.2.1 Test for Materials Compatibility
           8.2.2 Test for Residual Sanitizing Agents
           8.2.3 Tests Related to Product Water from Deionization
           8.2.4 Tests Related to Product Water from Electrodialysis
           8.2.5 Tests Related to Reverse Osmosis Monitoring Systems
           8.2.6 Filter Inspection
           8.2.7 Carbon Adsorption Media
           8.2.8 Ultraviolet Irradiators
    9 Verification of Equipment Installation and Operation
    Tables
    Annexes
    A (normative) - Guidelines for Chemical and Physical Parameters
      for Feed Water
    B (informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    Applies to a) acute, chronic, and home-based hemodialysis; b) water for preparing dialyzing fluid and concentrate for hemodialysis; c) all water intended for contact with the dialyzing fluid pathway; d) the baseline quality of the feed water and any other input water; e) water treatment and monitoring equipment; f) water distribution systems; and g) product water used for flushing blood pathways before sterilization (but not afterwards).

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By
    Supersedes

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

    CSA Z441 : 1988 TERMINOLOGY AND DEFINITIONS USED IN CSA HEALTH CARE TECHNOLOGY STANDARDS
    CSA Z364.1.1-Z364.1.2 : 0 HAEMODIALYZERS, HAEMOFILTERS, AND HAEMOCONCENTRATORS/EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYZERS, HAEMOFILTERS, AND HAEMOCONCENTRATORS
    CSA Z364.1.3 : 1998 : R2014 REUSE OF HAEMODIALYSERS
    CSA Z8637 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS

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

    CSA Z364.1.1 : M84 HEMODIALYSERS, HEMOFILTERS AND HEMOCONCENTRATORS
    CSA Z364.1.2 : M84 EXTRACORPOREAL CIRCUITS FOR USE WITH A HEMODIALYSER, HEMOFILTER, AND HEMOCONCENTRATOR
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