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CLSI MM3 A3 : 3ED 2015

Current

Current

The latest, up-to-date edition.

MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES

Published date

27-02-2015

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Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Applications
Chapter 3 - Specimen Collection, Transport, and
            Processing
Chapter 4 - Contributors to False-Negative Results and Controls
Chapter 5 - Methods
Chapter 6 - Selection and Qualification of Nucleic Acid Sequences
Chapter 7 - Establishment and Evaluation of Performance
            Characteristics of Molecular Diagnostic Tests
Chapter 8 - Quality Assurance
Chapter 9 - Reporting of Results
Chapter 10 - Recommendations for Manufactures and Clinical
             Laboratories
Chapter 11 - Conclusion
Chapter 12 - Supplemental Information
References
Additional References
Appendix Nucleic Acid Amplification Technologies
The Quality Management System Approach
Related CLSI References Materials

Defines general principles for the development, evaluation, and application of tests designed for direct detection of microorganisms in clinical specimens and for identification of microorganisms grown in culture.

DevelopmentNote
Supersedes CLSI MM3 A2. (03/2015)
DocumentType
Standard
PublisherName
Clinical Laboratory Standards Institute
Status
Current
Supersedes

ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

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CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
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