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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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY

Superseded date

02-02-2023

Published date

12-01-2013

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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Superseded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

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

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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