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  • CLSI H26 A2 : 2ED 2010

    Current The latest, up-to-date edition.

    VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  25-06-2010

    Publisher:  Clinical Laboratory Standards Institute

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    Abstract - (Show below) - (Hide below)

    Defines portions of the life cycle of an automated multi-channel hematolgoy system and provides guidance for validation, verification, calibration, quality assurance (QA), and quality control (QC) through standardized approaches to ensure good laboratory science and clinical relevance.

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

    Development Note Supersedes NCCLS H26 P2 and NCCLS H38 P. (07/2010)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Current
    Supersedes

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

    BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    I.S. EN ISO 15189:2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
    CLSI NBS06 A : 1ED 2013 NEWBORN BLOOD SPOT SCREENING FOR SEVERE COMBINED IMMUNODEFICIENCY BY MEASUREMENT OF T-CELL RECEPTOR EXCISION CIRCLES
    CLSI NBS07 : 1ED 2017 NEWBORN BLOOD SPOT SCREENING FOR POMPE DISEASE BY LYSOSOMAL ACID A-GLUCOSIDASE ACTIVITY ASSAYS
    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 I/LA34 P : 1ED 2010 DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS
    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 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 QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT

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

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    CLSI H44 A2 : 2ED 2004 METHODS FOR RETICULOCYTE COUNTING (FLOW CYTOMETRY AND SUPRAVITAL DYES)
    CLSI H52 A : 1ED 2000 FETAL RED CELL DETECTION
    CLSI EP21 A : 1ED 2003 ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
    CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
    CLSI H15 A3 : 3ED 2000 REFERENCE AND SELECTED PROCEDURES FOR THE QUANTITATIVE DETERMINATION OF HEMOGLOBIN IN BLOOD
    CLSI EP31 A : 1ED 2008 VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
    CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
    CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
    CLSI H42 A2 : 2ED 2007 ENUMERATION OF IMMUNOLOGICALLY DEFINED CELL POPULATIONS BY FLOW CYTOMETRY
    CLSI H20 A2 : 2ED 2007 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods, 2nd Edition
    CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    CLSI GP41 A6 : 6ED 2007 PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
    CLSI H7 A3 : 3ED 2000 PROCEDURE FOR DETERMINING PACKED CELL VOLUME BY THE MICROHEMATOCRIT METHOD
    CLSI I/LA24 A : 1ED 2004 FLUORESCENCE CALIBRATION AND QUANTITATIVE MEASUREMENT OF FLUORESCENCE INTENSITY
    CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
    CLSI GP42 A6 : 6ED 2008 PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS
    CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
    CLSI GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
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