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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY
16-06-2006
12-01-2013
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 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
Describes the water requirements for clinical laboratory testing procedures.
DocumentType |
Proposed Guideline
|
PublisherName |
Clinical Laboratory Standards Institute
|
Status |
Superseded
|
SupersededBy |
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 |
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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