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CLSI M50 P : 1ED 2008

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

QUALITY CONTROL FOR COMMERCIAL MICROBIAL IDENTIFICATION SYSTEMS
Superseded date

08-29-2008

Published date

01-12-2013

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
5 General Responsibilities of the Manufacturer, Distributor,
  and User
  5.1 Manufacturer
  5.2 The Distributor
  5.3 The User
6 Process for QC of MISs
  6.1 Manufacturer's Responsibilities
  6.2 User's Responsibilities to Qualify for Streamlined QC
7 QC Procedures for MISs
  7.1 QC Organisms
  7.2 QC Testing Process
  7.3 QC Testing Frequency
  7.4 Interpretation of QC Test Results
  7.5 Corrective Action
References
Appendix A - Manufacturer's Requirements for Streamlined QC
             Section of Package Insert or Product Information
             for an MIS
Appendix B - User's Requirements to Qualify for Streamlined
             QC of an MIS
Appendix C - Documentation of Streamlined QC Results - Minimum
             Record Requirements
Appendix D - Troubleshooting Guide for MIS QC Failures
The Quality Management System Approach
Related CLSI Reference Materials

Provides guidance for quality control of commercial systems for microbial identification from culture, including information that pertains to manufacturers, distributors, and laboratory users.

DocumentType
Proposed Guideline
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy

CLSI M7 A7 : 7ED 2006 METHODS FOR DILUTION ANTIMICROBIAL SUSCEPTIBILITY TESTS FOR BACTERIA THAT GROW AEROBICALLY
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI GP21 A2 : 2ED 2004 TRAINING AND COMPETENCE ASSESSMENT
CLSI M22 A3 : 3ED 2004 QUALITY CONTROL FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA
CLSI M2 A9 : 9ED 2006 PERFORMANCE STANDARDS FOR ANTIMICROBIAL DISK SUSCEPTIBILITY TESTS

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