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CLSI Standards: Guidelines for Health Care Excellence

Developed by our members for use by the global laboratory community, CLSI’s consensus-based medical laboratory standards are the most widely recognized resources for continually improving testing quality, safety, and efficiency.

Browse our collection of consensus-based medical laboratory standards documents. Choose from print or electronic versions of CLSI standards and guidelines.

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Effective 04 January 2024, CLSI is pleased to offer Country-Based Pricing for customers who meet established economic criteria. Visit our Country-Based Pricing page for more information about this new program. Note: Discounted pricing is available only when a customer is logged in to his/her CLSI account.

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Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures, 2nd Edition

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Laboratory Internal Audit Program, 2nd Edition

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In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
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User Evaluation of Acceptability of a Reagent Lot Change, 2nd Edition

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Principles and Procedures for Blood Cultures, 2nd Edition

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In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
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Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data, 5th Edition

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Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2
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A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition

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