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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
Number and Date

Title of Standard
04/04/2016 Materials 8-200 ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
08/21/2017 Materials 8-195 ASTM F2024-10 (Reapproved 2016) Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
07/09/2014 Materials 8-193 ASTM F2754/F2754M-09 (Reapproved 2013) Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
01/14/2019 Materials 8-179 ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
01/27/2015 Materials 8-171 ASTM F1609-08 (Reapproved 2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
01/30/2014 Materials 8-159 ISO 9584 First edition 1993-10-15 Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants
08/06/2013 Materials 8-158 ASTM F1713-08 (Reapproved 2013) Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130)
01/30/2014 Materials 8-157 ISO 9583 First edition 1993-10-15 Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants
08/06/2013 Materials 8-153 ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
04/04/2016 Materials 8-136 ASTM F2458-05 (Reapproved 2015) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
04/04/2016 Materials 8-135 ASTM F2392-04 (Reapproved 2015) Standard Test Method for Burst Strength of Surgical Sealants
01/30/2014 Materials 8-123 ISO 5832-5 Third edition 2005-10-15 Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
04/04/2016 Materials 8-121 ASTM F2005-05 (Reapproved 2015) Standard Terminology for Nickel-Titanium Shape Memory Alloys
04/04/2016 Materials 8-116 ASTM F2258-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
04/04/2016 Materials 8-115 ASTM F2256-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
04/04/2016 Materials 8-114 ASTM F2255-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading
06/07/2018 Materials 8-113 ASTM F1147-05 (Reapproved 2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
09/17/2018 Materials 8-112 ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
04/04/2016 Materials 8-107 ASTM F746-04 (Reapproved 2014) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
04/04/2016 Materials 8-103 ASTM F1801-97 (Reapproved 2014) Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
05/21/2007 Materials 8-68 ISO 13782:1996 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
09/09/2008 Materials 8-61 ISO 5832-6:1997 Implants for surgery -- Metallic materials -- Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
05/30/2022 InVitro Diagnostics 7-312 CLSI M39 5th Edition Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
12/20/2021 InVitro Diagnostics 7-311 CLSI EP39, 1st Edition A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
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
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
06/07/2021 InVitro Diagnostics 7-308 CLSI M100, 31st Edition Performance Standards for Antimicrobial Susceptibility Testing
06/07/2021 InVitro Diagnostics 7-307 CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring
06/07/2021 InVitro Diagnostics 7-306 CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures
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
12/21/2020 InVitro Diagnostics 7-304 CLSI M23 5th Edition Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
05/30/2022 InVitro Diagnostics 7-303 CLSI M60 2nd Edition Performance Standards for Antifungal Susceptibility Testing of Yeast
12/21/2020 InVitro Diagnostics 7-302 CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride Analysis
12/21/2020 InVitro Diagnostics 7-301 CLSI GP42 7th Edition Collection of Capillary Blood Specimens
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 7-299 CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring
07/06/2020 InVitro Diagnostics 7-298 CLSI EP35, 1st Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
07/06/2020 InVitro Diagnostics 7-297 ISO /TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
07/06/2020 InVitro Diagnostics 7-296 CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
12/23/2019 InVitro Diagnostics 7-295 CLSI M52, 1st ed. August 2015 (Reaffirmed: January 2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
12/23/2019 InVitro Diagnostics 7-293 CLSI QMS01, 5th ed. June 2019 (Replaces QMS01-A4) A Quality Management System Model for Laboratory Services.
06/07/2021 InVitro Diagnostics 7-292 CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
07/15/2019 InVitro Diagnostics 7-291 CLSI EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
07/15/2019 InVitro Diagnostics 7-290 CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
07/15/2019 InVitro Diagnostics 7-289 CLSI MM17 2nd Edition Verification and Validation of Multiplex Nucleic Acid Assays
07/15/2019 InVitro Diagnostics 7-288 CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
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
01/14/2019 InVitro Diagnostics 7-286 CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
01/14/2019 InVitro Diagnostics 7-285 CLSI M48-A 2nd Edition Laboratory Detection and Identification of Mycobacteria
09/17/2018 InVitro Diagnostics 7-284 CLSI EP37 1st Edition Supplemental Tables for Interference Testing in Clinical Chemistry
09/17/2018 InVitro Diagnostics 7-283 CLSI POCT04 3rd Edition Essential Tools for Implementation and Management of a Point-of-Care Testing Program
09/17/2018 InVitro Diagnostics 7-280 CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests
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 7-278 CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
09/17/2018 InVitro Diagnostics 7-277 CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens
09/17/2018 InVitro Diagnostics 7-276 CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
09/17/2018 InVitro Diagnostics 7-275 CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry.
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
08/21/2017 InVitro Diagnostics 7-272 CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
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
01/14/2019 InVitro Diagnostics 7-269 CLSI MM23-1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
12/23/2016 InVitro Diagnostics 7-268 CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory 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
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
09/21/2016 InVitro Diagnostics 7-265 CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
06/27/2016 InVitro Diagnostics 7-264 CLSI MM21-1st Edition (Reaffirmed: January 2020) Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
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
04/04/2016 InVitro Diagnostics 7-260 CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
04/04/2016 InVitro Diagnostics 7-259 CLSI GP23-A2 (Replaces GP23-A) Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; 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 7-255 CLSI MM09-A2 (Replaces MM09-A) Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition
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
08/14/2015 InVitro Diagnostics 7-252 CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
08/14/2015 InVitro Diagnostics 7-251 CLSI EP05-A3 (Reaffirmed: September 2019) Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
01/27/2015 InVitro Diagnostics 7-250 CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second 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
08/06/2013 InVitro Diagnostics 7-243 CLSI M51-A (Replaces M51-P) Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; 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 7-239 CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report
01/15/2013 InVitro Diagnostics 7-238 CLSI MM06-A2 (Replaces MM06-A) Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
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
06/07/2021 InVitro Diagnostics 7-236 CLSI M43-A October 2011 Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
01/15/2013 InVitro Diagnostics 7-235 CLSI EP25-A (Replaces EP25-P) Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
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
01/15/2013 InVitro Diagnostics 7-233 CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
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
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
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
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
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
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.
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.
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
10/04/2010 InVitro Diagnostics 7-212 CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
01/30/2014 InVitro Diagnostics 7-210 CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
05/05/2010 InVitro Diagnostics 7-207 CLSI GP16-A3 (Replaces GP16-A2) Urinalysis; Approved Guideline - 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.
08/20/2012 InVitro Diagnostics 7-197 CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
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