• CLSI C3 P4 : 4ED 2005

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY

    Available format(s): 

    Superseded date:  16-06-2006

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Clinical Laboratory Standards Institute

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

    Abstract
    Committee Membership
    Foreword
    1 Scope
    2 Introduction
    3 Definitions
    4 Specifications
      4.1 Organization of Water Purity Specifications
      4.2 Clinical Laboratory Reagent Water (CLRW)
      4.3 Special Reagent Water (SRW)
      4.4 Instrument Feed Water
      4.5 Water Supplied by a Method Manufacturer for Use as a
          Diluent or Reagent
      4.6 Prepackaged Bottled Water
      4.7 Autoclave and Wash Water Applications
    5 Validation and Trend Monitoring
      5.1 Validation of Purified Water as Fit for Its Intended
          Purpose in Laboratory Procedures
      5.2 Trend Monitoring of Water Purity Specifications
      5.3 Water Purification System Validation
    6 Design Considerations
      6.1 Filters
      6.2 Reverse Osmosis (RO) Membranes
      6.3 Contactor Membranes
      6.4 Ion-Exchange Resins
      6.5 Activated Carbon
      6.6 Distillation
      6.7 Ultraviolet Light
      6.8 Storage and Distribution
    7 Testing
      7.1 Resistivity
      7.2 Microbial Content by Colony Count
      7.3 Microbial Content by Epifluorescence Microscopy
      7.4 Endotoxins
      7.5 Determination of Oxidizable Organic Substances,
          Expressed as Total Organic Carbon (TOC)
    References
    Additional References
    Appendix A. Permeability of Plastic Piping to Atmospheric
                CO[2]
    Appendix B. Resistivity Measurement in a Sparged Water
                Sample
    Appendix C. Methods for Correction or Compensation of
                Resistivity Measurements
    Summary of Comments and Subcommittee Responses
    The Quality System Approach
    Related CLSI/NCCLS Publications

    Abstract - (Show below) - (Hide below)

    Describes the water requirements for clinical laboratory testing procedures.

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

    Document Type Proposed Guideline
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By

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

    BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    CLSI MM1 A2 : 2ED 2006 MOLECULAR DIAGNOSTIC METHODS FOR GENETIC DISEASES

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

    CLSI C24 A2 : 2ED 99 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENTS: PRINCIPLES AND DEFINITIONS
    CLSI EP7 A : 1ED 2002 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    CLSI GP2 A4 : 4ED 2002 CLINICAL LABORATORY TECHNICAL PROCEDURE MANUALS
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