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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Specialty Task Group Area: InVitro Diagnostics
 
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07/06/2020 InVitro Diagnostics 7-297 Complete ISO TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
08/20/2012 InVitro Diagnostics 7-76 Complete CLSI M15-A (Replaces M15-T) Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
01/30/2014 InVitro Diagnostics 7-224 Complete 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 Complete CLSI QMS06-A3 (Formerly GP22-A3) Quality Management System: Continual Improvement; Approved Guideline - Third Edition
09/17/2018 InVitro Diagnostics 7-275 Complete CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry.
05/26/2025 Software/
Informatics		 13-148 Complete IEEE Std 11073-10417-2023 Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter
12/22/2025 InVitro Diagnostics 7-346 Complete CLSI EP32 2nd Edition Implementation of Metrological Traceability in Laboratory Medicine
05/26/2025 InVitro Diagnostics 7-344 Complete CLSI AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition
05/29/2023 InVitro Diagnostics 7-315 Complete CLSI EP12 3rd Edition Evaluation of Qualitative, Binary Output Examination Performance
05/29/2023 InVitro Diagnostics 7-316 Complete CLSI NBS01 7th Edition Dried Blood Spot Specimen Collection for Newborn Screening
05/26/2025 InVitro Diagnostics 7-341 Complete CLSI AUTO03-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard - Second Edition
05/26/2025 InVitro Diagnostics 7-342 Complete CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
05/26/2025 InVitro Diagnostics 7-343 Complete CLSI AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard
05/26/2025 InVitro Diagnostics 7-345 Complete CLSI AUTO13-A2 (Formerly GP19-A2) Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition
05/26/2025 InVitro Diagnostics 7-337 Complete CLSI AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline
12/20/2021 InVitro Diagnostics 7-309 Complete 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 Complete ISO 19238 Second edition 2014-02-01 Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
12/20/2021 InVitro Diagnostics 7-311 Complete CLSI EP39, 1st Edition A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
03/18/2009 InVitro Diagnostics 7-170 Complete CLSI I/LA21-A2 Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition
03/18/2009 InVitro Diagnostics 7-176 Complete CLSI I/LA30-A (Replaces I/LA30-P) Immunoassay Interference by Endogenous Antibodies; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-180 Complete CLSI M34-A (Replaces M24-P) Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-182 Complete CLSI M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-185 Complete CLSI M41-A Viral Culture; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-190 Complete CLSI M50-A (Replaces M50-P) Quality Control for Commercial Microbial Identification Systems; Approved Guideline
08/14/2015 InVitro Diagnostics 7-251 Complete CLSI EP05-A3 (Reaffirmed: September 2019) Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
08/14/2015 InVitro Diagnostics 7-252 Complete CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
12/19/2022 InVitro Diagnostics 7-313 Complete CLSI EP27 2nd Edition Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
05/26/2025 InVitro Diagnostics 7-329 Complete CLSI EP06-EG 2nd Edition Developer Validation of Linearity, Establishment Guide
12/21/2020 InVitro Diagnostics 7-300 Complete CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
05/26/2025 InVitro Diagnostics 7-333 Complete CLSI AUTO04-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
03/08/2004 InVitro Diagnostics 7-86 Complete 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 Complete 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 Complete 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 Complete 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 Complete CLSI H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
10/04/2004 InVitro Diagnostics 7-104 Complete 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 Complete CLSI H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
08/20/2012 InVitro Diagnostics 7-148 Complete 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 7-175 Complete CLSI C59-A Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
12/18/2023 InVitro Diagnostics 7-318 Complete CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
07/09/2014 InVitro Diagnostics 7-213 Complete CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
03/18/2009 InVitro Diagnostics 7-189 Complete CLSI M47-A (Replaces M47-P) Principles and Procedures for Blood Cultures; Approved Guideline
12/23/2024 InVitro Diagnostics 7-322 Complete CLSI M47 2nd Edition Principles and Procedures for Blood Cultures
07/28/2025 General II (ES/
EMC)		 19-57 Complete IEC 61326-2-6 Edition 4.0 2025-06 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
03/18/2009 InVitro Diagnostics 7-192 Complete CLSI MM18-A (Replaces MM18-P) Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline
03/18/2009 InVitro Diagnostics 7-71 Complete CLSI H15-A3 (Replaces H15-A2) Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
03/18/2009 InVitro Diagnostics 7-145 Complete CLSI H42-A2 (Replaces H42-A) Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
03/16/2012 InVitro Diagnostics 7-165 Complete 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 Complete CLSI GP20-A2 (Replaces GP20-A) Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition
03/16/2012 InVitro Diagnostics 7-225 Complete 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 Complete CLSI I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
08/06/2013 InVitro Diagnostics 7-242 Complete CLSI C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
09/17/2018 InVitro Diagnostics 7-279 Complete CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
09/17/2018 InVitro Diagnostics 7-280 Complete CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests
08/14/2015 InVitro Diagnostics 7-257 Complete CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
08/14/2015 InVitro Diagnostics 7-253 Complete CLSI EP15-A3 (Reaffirmed: September 2019) User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition
09/17/2018 InVitro Diagnostics 7-283 Complete CLSI POCT04 3rd Edition Essential Tools for Implementation and Management of a Point-of-Care Testing Program
12/21/2020 InVitro Diagnostics 7-299 Complete CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring
12/22/2025 InVitro Diagnostics 7-348 Complete CLSI EP37 2nd Edition Supplemental Tables for Interference Testing in Clinical Chemistry
12/22/2025 InVitro Diagnostics 7-349 Complete CLSI EP35 2nd Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
07/06/2020 InVitro Diagnostics 7-298 Complete CLSI EP35, 1st Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
09/17/2018 InVitro Diagnostics 7-284 Complete CLSI EP37 1st Edition Supplemental Tables for Interference Testing in Clinical Chemistry
11/08/2005 InVitro Diagnostics 7-113 Complete CLSI I/LA23-A (Replaces I/LA23-P) Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
09/17/2018 InVitro Diagnostics 7-277 Complete CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens
09/17/2018 InVitro Diagnostics 7-278 Complete CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
03/16/2012 InVitro Diagnostics 7-227 Complete 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 Complete CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
01/15/2013 InVitro Diagnostics 7-237 Complete 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 Complete CLSI MM06-A2 (Replaces MM06-A) Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
05/05/2010 InVitro Diagnostics 7-207 Complete CLSI GP16-A3 (Replaces GP16-A2) Urinalysis; Approved Guideline - Third Edition
10/04/2010 InVitro Diagnostics 7-212 Complete CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
07/09/2014 InVitro Diagnostics 7-48 Complete CLSI C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
07/09/2014 InVitro Diagnostics 7-221 Complete CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
12/23/2019 InVitro Diagnostics 7-293 Complete CLSI QMS01, 5th ed. June 2019 (Replaces QMS01-A4) A Quality Management System Model for Laboratory Services.
12/23/2019 InVitro Diagnostics 7-295 Complete CLSI M52, 1st ed. August 2015 (Reaffirmed: January 2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
04/04/2016 InVitro Diagnostics 7-260 Complete CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
12/23/2024 InVitro Diagnostics 7-324 Complete CLSI M07 12th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
05/26/2025 InVitro Diagnostics 7-332 Complete CLSI AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
05/26/2025 InVitro Diagnostics 7-338 Complete CLSI AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline
09/17/2018 InVitro Diagnostics 7-276 Complete CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
12/21/2020 InVitro Diagnostics 7-302 Complete CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride Analysis
05/26/2025 InVitro Diagnostics 7-331 Complete CLSI AUTO02-A2 Laboratory Automation: Bar Codes for Specimen Container Identification - Second Edition
12/21/2020 InVitro Diagnostics 7-305 Complete 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
12/21/2020 InVitro Diagnostics 7-301 Complete CLSI GP42 7th Edition Collection of Capillary Blood Specimens
01/30/2014 InVitro Diagnostics 7-239 Complete CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report
01/14/2019 InVitro Diagnostics 7-139 Complete CLSI QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition
05/26/2025 Software/
Informatics		 13-145 Complete IEEE Std 11073-10419:2023 Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump
05/30/2022 InVitro Diagnostics 7-312 Complete CLSI M39 5th Edition Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
05/26/2025 Software/
Informatics		 13-144 Complete ISO IEEE 11073-10425 Edition 3, 2024-09 Health informatics - Device interoperability Part 10425: Personal health device communication - Device specialization - Continuous Glucose Monitor (CGM)
IEEE Std 11073-10425-2023 Health informatics - Device Interoperability Part 10425: Personal Health Device Communication - Device Specialization - Continuous Glucose Monitor (CGM)
12/23/2024 InVitro Diagnostics 7-323 Complete CLSI EP19 3rd Edition A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
07/15/2019 InVitro Diagnostics 7-287 Complete 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 Complete CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
08/20/2012 InVitro Diagnostics 7-197 Complete CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
01/14/2019 InVitro Diagnostics 7-286 Complete CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
05/26/2025 InVitro Diagnostics 7-335 Complete CLSI POCT01-A2 Point-of-Care Connectivity - Second Edition
05/26/2025 InVitro Diagnostics 7-336 Complete CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition.
06/07/2021 InVitro Diagnostics 7-307 Complete CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring
12/22/2025 InVitro Diagnostics 7-347 Complete CLSI EP21 3rd Edition Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
12/23/2016 InVitro Diagnostics 7-267 Complete CLSI C24 4th Edition (Replaces C24-A3) Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
01/14/2019 InVitro Diagnostics 7-285 Complete CLSI M48-A 2nd Edition Laboratory Detection and Identification of Mycobacteria
 
 
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