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U.S. Department of Health and Human Services

Recognized Consensus Standards
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07/15/2019 InVitro Diagnostics 7-289 CLSI MM17 2nd Edition Verification and Validation of Multiplex Nucleic Acid Assays
07/15/2019 InVitro Diagnostics 7-290 CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
06/07/2021 InVitro Diagnostics 7-262 CLSI M45 3rd Edition Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
06/07/2021 InVitro Diagnostics 7-292 CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
01/30/2014 InVitro Diagnostics 7-220 CLSI H59-A (Replaces H59-P) Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.
01/14/2019 InVitro Diagnostics 7-269 CLSI MM23-1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
08/06/2013 InVitro Diagnostics 7-234 CLSI EP24-A2 (Replaces GP 10-A) Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition
06/07/2021 InVitro Diagnostics 7-308 CLSI M100, 31st Edition Performance Standards for Antimicrobial Susceptibility Testing
01/30/2014 InVitro Diagnostics 7-239 CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report
12/20/2021 InVitro Diagnostics 7-309 ISO 17099 First edition 2014-11-15 Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
12/20/2021 InVitro Diagnostics 7-310 ISO 19238 Second edition 2014-02-01 Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
07/09/2014 InVitro Diagnostics 7-213 CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
03/08/2004 InVitro Diagnostics 7-86 CLSI C29-A2 (Replaces C29-A) Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition
03/08/2004 InVitro Diagnostics 7-87 CLSI C31-A2 (Replaces C31-A) Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition.
03/08/2004 InVitro Diagnostics 7-88 CLSI C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
03/08/2004 InVitro Diagnostics 7-89 CLSI C39-A (Replaces C39-P) A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard
10/04/2004 InVitro Diagnostics 7-105 CLSI H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
10/04/2004 InVitro Diagnostics 7-104 CLSI H7-A3 Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition.
05/05/2010 InVitro Diagnostics 7-205 CLSI H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
09/09/2008 InVitro Diagnostics 7-21 CLSI C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline
09/09/2008 InVitro Diagnostics 7-136 CLSI I/LA2-A2 (Replaces I/LA2-A) Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition.
09/09/2008 InVitro Diagnostics 7-159 CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
09/09/2008 InVitro Diagnostics 7-163 CLSI H56-A (Replaces H56-P) Body Fluid Analysis for Cellular Composition; Approved Guideline.
05/05/2010 InVitro Diagnostics 7-207 CLSI GP16-A3 (Replaces GP16-A2) Urinalysis; Approved Guideline - Third Edition
09/17/2018 InVitro Diagnostics 7-283 CLSI POCT04 3rd Edition Essential Tools for Implementation and Management of a Point-of-Care Testing Program
12/19/2022 InVitro Diagnostics 7-313 CLSI EP27 2nd Edition Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
12/23/2016 InVitro Diagnostics 7-267 CLSI C24 4th Edition (Replaces C24-A3) Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
07/09/2014 InVitro Diagnostics 7-175 CLSI C59-A Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
08/21/2017 InVitro Diagnostics 7-270 CLSI I/LA-20 3rd Edition (Replaces I/LA20-A3) Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
04/04/2016 InVitro Diagnostics 7-260 CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
01/14/2019 InVitro Diagnostics 7-285 CLSI M48-A 2nd Edition Laboratory Detection and Identification of Mycobacteria
07/06/2020 InVitro Diagnostics 7-297 ISO /TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
08/21/2017 InVitro Diagnostics 7-273 CLSI M58 1st Edition Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
03/18/2009 InVitro Diagnostics 7-145 CLSI H42-A2 (Replaces H42-A) Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
03/18/2009 InVitro Diagnostics 7-71 CLSI H15-A3 (Replaces H15-A2) Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
11/08/2005 InVitro Diagnostics 7-113 CLSI I/LA23-A (Replaces I/LA23-P) Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
03/18/2009 InVitro Diagnostics 7-192 CLSI MM18-A (Replaces MM18-P) Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline
08/06/2013 InVitro Diagnostics 7-242 CLSI C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
01/30/2014 InVitro Diagnostics 7-152 CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition.
08/14/2015 InVitro Diagnostics 7-257 CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
08/14/2015 InVitro Diagnostics 7-251 CLSI EP05-A3 (Reaffirmed: September 2019) Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
09/21/2016 InVitro Diagnostics 7-266 CLSI EP19 2nd Edition (Replaces EP19-R) A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
08/14/2015 InVitro Diagnostics 7-253 CLSI EP15-A3 (Reaffirmed: September 2019) User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition
01/30/2014 InVitro Diagnostics 7-244 CLSI NBS01-A6 (Replaces LA04-A5) Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition
01/30/2014 InVitro Diagnostics 7-224 CLSI EP28-A3c (Formerly C28-A3c) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition
01/30/2014 InVitro Diagnostics 7-223 CLSI QMS06-A3 (Formerly GP22-A3) Quality Management System: Continual Improvement; Approved Guideline - Third Edition
03/16/2012 InVitro Diagnostics 7-227 CLSI M53-A (Replaces M53-P) Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
01/15/2013 InVitro Diagnostics 7-233 CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
01/15/2013 InVitro Diagnostics 7-235 CLSI EP25-A (Replaces EP25-P) Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
01/15/2013 InVitro Diagnostics 7-237 CLSI MM01-A3 (Replaces MM01-A2) Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition
01/15/2013 InVitro Diagnostics 7-238 CLSI MM06-A2 (Replaces MM06-A) Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
08/20/2012 InVitro Diagnostics 7-76 CLSI M15-A (Replaces M15-T) Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
08/20/2012 InVitro Diagnostics 7-197 CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
03/16/2012 InVitro Diagnostics 7-150 CLSI H43-A2 Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
08/20/2012 InVitro Diagnostics 7-148 CLSI M28-A2 (Replaces M28-A) Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition.
07/09/2014 InVitro Diagnostics 7-48 CLSI C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
07/09/2014 InVitro Diagnostics 7-221 CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
09/17/2018 InVitro Diagnostics 7-284 CLSI EP37 1st Edition Supplemental Tables for Interference Testing in Clinical Chemistry
09/17/2018 InVitro Diagnostics 7-277 CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens
09/17/2018 InVitro Diagnostics 7-278 CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
09/17/2018 InVitro Diagnostics 7-279 CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
09/17/2018 InVitro Diagnostics 7-280 CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests
10/04/2010 InVitro Diagnostics 7-212 CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
03/16/2012 InVitro Diagnostics 7-165 CLSI H20-A2 (Replaces H20-A) Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
03/16/2012 InVitro Diagnostics 7-166 CLSI GP20-A2 (Replaces GP20-A) Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition
03/16/2012 InVitro Diagnostics 7-225 CLSI GP34-A (Replaces GP34-P) Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
08/02/2011 InVitro Diagnostics 7-219 CLSI I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
03/18/2009 InVitro Diagnostics 7-189 CLSI M47-A (Replaces M47-P) Principles and Procedures for Blood Cultures; Approved Guideline
03/18/2009 InVitro Diagnostics 7-190 CLSI M50-A (Replaces M50-P) Quality Control for Commercial Microbial Identification Systems; Approved Guideline
03/18/2009 InVitro Diagnostics 7-170 CLSI I/LA21-A2 Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition
03/18/2009 InVitro Diagnostics 7-176 CLSI I/LA30-A (Replaces I/LA30-P) Immunoassay Interference by Endogenous Antibodies; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-180 CLSI M34-A (Replaces M24-P) Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-182 CLSI M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-185 CLSI M41-A Viral Culture; Approved Guideline.
01/14/2019 InVitro Diagnostics 7-232 CLSI MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition
06/07/2021 InVitro Diagnostics 7-306 CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures
08/14/2015 InVitro Diagnostics 7-252 CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
01/14/2019 InVitro Diagnostics 7-178 CLSI M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition
09/17/2018 InVitro Diagnostics 7-275 CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry.
09/17/2018 InVitro Diagnostics 7-276 CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
07/06/2020 InVitro Diagnostics 7-298 CLSI EP35, 1st Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
01/14/2019 InVitro Diagnostics 7-286 CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
07/15/2019 InVitro Diagnostics 7-287 CLSI M44-S3 (2018) Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
07/15/2019 InVitro Diagnostics 7-288 CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
01/14/2019 InVitro Diagnostics 7-139 CLSI QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition
06/07/2021 InVitro Diagnostics 7-307 CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring
12/21/2020 InVitro Diagnostics 7-300 CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
12/21/2020 InVitro Diagnostics 7-301 CLSI GP42 7th Edition Collection of Capillary Blood Specimens
12/21/2020 InVitro Diagnostics 7-302 CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride Analysis
12/21/2020 InVitro Diagnostics 7-304 CLSI M23 5th Edition Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
12/21/2020 InVitro Diagnostics 7-305 ISO 17511 Second edition 2020-04 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
06/07/2021 General Plastic Surgery/
General Hospital		 6-463 IEC 60601-2-21 Edition 3.0 2020-09 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
08/21/2017 General Plastic Surgery/
General Hospital		 6-388 ANSI AAMI IEC 60601-2-21:2009/A1:2016 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
IEC 60601-2-21 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
12/21/2020 General Plastic Surgery/
General Hospital		 6-450 IEC 60601-2-50 Edition 3.0 2020-09 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
12/23/2019 General Plastic Surgery/
General Hospital		 6-427 ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
01/30/2014 General Plastic Surgery/
General Hospital		 6-321 IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
12/23/2019 General Plastic Surgery/
General Hospital		 6-426 ISO 23907-1 First edition 2019-01 Sharps injury protection - Requirements and test methods - Sharps containers
08/21/2017 General Plastic Surgery/
General Hospital		 6-387 ANSI AAMI IEC 60601-2-50:2009/A1:2016 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
IEC 60601-2-50 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
12/23/2019 General Plastic Surgery/
General Hospital		 6-425 ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
07/06/2020 General Plastic Surgery/
General Hospital		 6-444 ASTM D7103-19 Standard Guide for Assessment of Medical Gloves
 
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