CLSI GP31 P : 1ED 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE
30-04-2009
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
3.1 Definitions
3.2 Acronyms/Abbreviations
4 Instrument Implementation and Performance Verification
4.1 Implementation
5 Instrument Operational Verification and Maintenance Program
5.1 Recommendations for an Instrument Verification and
Maintenance Program
5.2 Applicable Regulations and Documentation Requirements
5.3 Documentation
6 Basic Laboratory Instrumentation
6.1 General-Purpose Centrifuges
6.2 Microhematocrit Centrifuges (Dedicated, Fixed RPM)
6.3 Refrigerated Centrifuges
6.4 Pipettors and Dilutors
6.5 Photometry and Other Light-Based Devices
6.6 Glassware Washers
6.7 Histology Equipment
6.8 Biological Cabinets and Fume Hoods
6.9 Osmometers
6.10 Refractometers
6.11 Shakers and Rotators
6.12 Temperature-Dependent Equipment
6.13 Gamma Counters and Liquid Scintillation Counters
7 Specialized Laboratory Instrumentation
7.1 Automated Hematology Analyzers
7.2 Coagulation Analyzers
7.3 Automated Chemistry Analyzers
7.4 Automated Immunoassay Analyzers
7.5 Electrode-Based Instruments
7.6 CO-oximeters
7.7 Flow Cytometry
References
Additional References
The Quality Management System Approach
Related CLSI/NCCLS Publications
Provides information about assessing instrument performance and function from the time of instrument purchase to the routine performance of clinical testing.
DocumentType |
Proposed Guideline
|
PublisherName |
Clinical Laboratory Standards Institute
|
Status |
Superseded
|
SupersededBy |
CLSI H44 A2 : 2ED 2004 | METHODS FOR RETICULOCYTE COUNTING (FLOW CYTOMETRY AND SUPRAVITAL DYES) |
CLSI H15 A3 : 3ED 2000 | REFERENCE AND SELECTED PROCEDURES FOR THE QUANTITATIVE DETERMINATION OF HEMOGLOBIN IN BLOOD |
CLSI HS3 A : 1ED 2005 | PULSE OXIMETRY |
CLSI GP17 A2 : 2ED 2004 | CLINICAL LABORATORY SAFETY |
CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
CLSI H7 A3 : 3ED 2000 | PROCEDURE FOR DETERMINING PACKED CELL VOLUME BY THE MICROHEMATOCRIT METHOD |
CLSI H26 A : 1ED 96 | PERFORMANCE GOALS FOR THE INTERNAL QUALITY CONTROL OF MULTICHANNEL HEMATOLOGY ANALYZERS |
CLSI GP26 A3 : 3ED 2004 | APPLICATION OF A QUALITY MANAGEMENT SYSTEM MODEL FOR LABORATORY SERVICES |
CLSI C46 A : 1ED 2001 | BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS |
CLSI GP22 A2 : 2ED 2004 | CONTINUOUS QUALITY IMPROVEMENT: INTEGRATING FIVE KEY QUALITY SYSTEM COMPONENTS |
CLSI H21 A4 : 4ED 2003 | COLLECTION, TRANSPORT, AND PROCESSING OF BLOOD SPECIMENS FOR TESTING PLASMA-BASED COAGULATION ASSAYS |
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