• CLSI GP31 A : 1ED 2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-03-2023

    Language(s):  English

    Published date:  01-04-2009

    Publisher:  Clinical Laboratory Standards Institute

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    Abstract
    Committee Membership
    Foreword
    1 Scope
    2 Introduction
    3 Terminology
    4 Instrument Implementation and Performance Verification
    5 Instrument Operational Versification and Maintenance
      Program
    6 Basic Laboratory Instrumentation
    7 Specialized Laboratory Instrumentation
    References
    Additional References
    Summary of Delegate and Area Committee Responses
    The Quality Management System Approach
    Related CLSI Reference Materials

    Abstract - (Show below) - (Hide below)

    This guideline provides a basic understanding of the considerations for the implementation, verification, and maintenance of laboratory equipment. Recommendations are generic and not substitutes for specific information provided by a given instrument’s manufacturer.

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

    Development Note Supersedes NCCLS GP31 P. (05/2009)
    Document Type Standard
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

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

    CLSI GP37 P : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    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)
    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)
    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
    CLSI M29 A4 : 4ED 2014 Protection of Laboratory Workers From Occupationally Acquired Infections
    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)

    CLSI C46 A2 : 2ED 2009 BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS
    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 HS3 A : 1ED 2005 PULSE OXIMETRY
    CLSI QMS04 A2 : 2ED 2007 LABORATORY DESIGN
    CLSI GP17 A2 : 2ED 2004 CLINICAL LABORATORY SAFETY
    CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
    CLSI QMS07 A2 : 2ED 2006 APPLICATION OF A QUALITY MANAGEMENT SYSTEM MODEL FOR RESPIRATORY SERVICES
    CLSI GP40 A4 : 4ED 2006 PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY
    CLSI H7 A3 : 3ED 2000 PROCEDURE FOR DETERMINING PACKED CELL VOLUME BY THE MICROHEMATOCRIT METHOD
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective