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CLSI GP40 A4 : 4ED 2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

02-02-2023

Published date

01-12-2013

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

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

DevelopmentNote
Supersedes NCCLS C3 A3 and NCCLS C3 P4 (07/2006) Formerly CLSI C3 A4. (07/2013)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

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