CLSI M52 : 1ED 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems, 1st Edition
Hardcopy , PDF
04-01-2023
English
02-18-2020
Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Requirements for Implementation of
Commercial Test System
Chapter 3 - The Microbial Identification System and
Antimicrobial Susceptibility Testing System
Verification Process
Chapter 4 - Post verification Quality Assurance for Microbial
Identification and Antimicrobial Susceptibility
Testing System
Chapter 5 - Conclusion
Chapter 6 - Supplemental Information
References
Appendix A - Regulatory Requirements for US Food
and Drug Administration Clearance of
Commercial Devices and International Organization
for Standardization Certification of Device
Manufactures
Appendix B - Verification Testing of Revised CLSI
Breakpoints
Appendix C - Examples of Verification Protocols
Appendix D - Verification Data Example for Microbial
Identification Systems
Appendix E - CLSI Quality Control Strains That May Be
Considered for Verification of Antimicrobial
Susceptibility Testing System
Appendix F - Antimicrobial Susceptibility Testing System
Verification Worksheets and Data Summary
Examples
The Quality Management System Approach
Related CLSI References Materials
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