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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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In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice
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Next-Generation In Vitro Diagnostic Instrument Interface, 1st Edition

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Developing and Using Quality Indicators for Laboratory Improvement, 2nd Edition

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ISO 20186-1E Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 1: Isolated cellular RNA
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ISO 20186-2E Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 2: Isolated genomic DNA
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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA
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Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures
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Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts, 3rd Edition

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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA
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Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins
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