New and updated standards
Shop | Clinical & Laboratory Standards Institute
Includes M100 Antimicrobial Susceptibility Testing 2026
EP05 Plus – Evaluation of Precision of Quantitative Measurement Procedures 4th Ed Dec 2025
MM19 – Establishing Molecular Testing in Medical Laboratory Environments Nov 2025
Documents for Public Review | CLSI
EP17-Ed3 (Proposed Draft) – Evaluation of Detection Capability for Medical Laboratory Measurement Procedures. CLSI EP17 provides guidance on evaluating and documenting the detection capability of medical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), on verifying manufacturers’ detection capability claims, and on the proper use and interpretation of different detection capability estimates. This document is available to the public for review and comment for 45 days. (15 January to 2 March.)
Withdrawn & Corrections | CLSI
Includes Corrections to:
CLSI EP30-Ed 2 – Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine
CLSI EP35-Ed2 – Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Procedures
Including for 2026
Product Number: Edition: Title: Projected Publication date: Status: Product Type.
AUTO16 2nd Ed. Next-Generation In Vitro Diagnostic Instrument Interface 2026-06-30 Resolution Standard
C46 3rd Ed. Blood Gas and pH Analysis and Related Measurements 2026-10-30 Resolution Guideline
C62 3rd Ed. Liquid Chromatography-Mass Spectrometry Methods 2026-07-31 Resolution Guideline
C65 1st Ed. Biochemical Tumor Marker Testing 2026-03-31 Resolution Guideline
EP06 3rd Ed. Evaluation of Linearity of Quantitative Measurement Procedures 2026-06-30 Development Guideline
EP49 1st Ed. Framework for Developing Evidence of Clinical Validity of Medical Laboratory Test Methods 2026-04-30 Resolution Guideline
MN 3rd Ed. Method Navigator 2026-07-31 Development Other
GP50 1st Ed. Clinical Testing for Early Detection and Management of Sepsis 2026-10-30 Resolution Guideline
H20 3rd Ed. Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods 2026-04-30 Resolution Guideline
ILA20 4th Ed. Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities 2026-09-30 Resolution Guideline
M27 4th Ed. Performance Standards for Antifungal Susceptibility Testing of Yeasts 2026-05-29 Resolution Supplement
M38 4th Ed. Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi 2026-03-31 Resolution Supplement
M52 2nd Ed. Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems 2026-12-31 Resolution Guideline
M57 5th Ed. Epidemiological Cutoff Values for Antifungal Susceptibility Testing 2026-11-30 Development Supplement
M66 1st Ed. Methods for Active Surveillance of Multidrug-Resistant Organisms 2026-09-30 Resolution Guideline
M68 1st Ed. Validation of Commercial Antimicrobial Susceptibility Test (AST) Breakpoints 2026-12-31 Resolution Guideline
M100 36th Ed. Performance Standards for Antimicrobial Susceptibility Testing 2026-01-22 Resolution Supplement
MM06 3rd Ed. Quantitative Molecular Methods for Infectious Diseases 2026-08-31 Resolution Guideline
MM29 1st Ed. Interpretive Framework Heritable Disorders 2026-07-31 Development Report
NBS06 2nd Ed. Newborn Screening for Severe Combined Immunodeficiency and Other Related Severe Immunodeficiencies 2026-02-28 Approval Guideline
NBS12 1st Ed. Newborn Screening for Galactosemia 2026-04-30 Resolution Guideline
NBS15 1st Ed. Newborn Screening Program Administration and Evaluation 2026-10-29 Development Report
PRE06 1st Ed. Validation of External Transport Systems 2026-02-28 Approval Guideline
