• CLSI GP40 A4 : 4ED 2006

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  02-02-2023

    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 Commercially Bottled, Purified 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 - Resistivity Measurement in a Sparged Water
                 Sample
    Appendix B - Methods for Correction or Compensation of
                 Resistivity Measurements
    Summary of Consensus and Delegate Comments and Working
    Group Responses
    The Quality System Approach
    Related CLSI/NCCLS Publications

    Abstract - (Show below) - (Hide below)

    Provides guidelines on water purified for clinical laboratory use; methods for monitoring water quality and testing for specific contaminants; and water system design considerations.

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

    Development Note Supersedes NCCLS C3 A3 and NCCLS C3 P4 (07/2006) Formerly CLSI C3 A4. (07/2013)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

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

    CLSI M43 A : 1ED 2011 METHODS FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING FOR HUMAN MYCOPLASMAS
    BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    I.S. EN ISO 15189:2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
    PREN ISO 15189 : DRAFT 2011 MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    UNE-EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
    CLSI QMS04 : 2016 LABORATORY DESIGN
    CLSI C34 A3 : 3ED 2009 SWEAT TESTING: SAMPLE COLLECTION AND QUANTITATIVE CHLORIDE ANALYSIS
    11/30173018 DC : 0 BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    DIN EN ISO 15189:2014-11 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
    UNI EN ISO 15189 : 2013 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    CLSI MM19 P : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI QMS04 A2 : 2ED 2007 LABORATORY DESIGN
    CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
    CLSI GP31 A : 1ED 2009 LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE

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

    CLSI C24 A2 : 2ED 99 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENTS: PRINCIPLES AND DEFINITIONS
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    CLSI GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
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