Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
901 to 1000 of 1497 Results
 < 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 13 
 14 
 > 
Results per Page
New Search export reports to excelExport to Excel HelpStandards Search Assistance
Date of
Entry
Sort by Date [Old to new]
Sort by Date [New to old]
Specialty Task
Group Area
Sort by Specialty Task Group Area [A-Z]
Sort by Specialty Task Group Area [Z-A]
Recognition
Number
Sort by Recognition Number [0-9]
Sort by Recognition Number [9-0]
Extent of
Recognition
Sort by Extent of Recognition [A-Z]
Sort by Extent of Recognition [Z-A]
Standards
Developing
Organization

Standard Designation
Number and Date
 

Standard Title
(click for recognition information)
 
01/30/2014 Materials 8-358 Complete ASTM F1855-00 (Reapproved 2019) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
06/07/2018 Materials 8-356 Complete ASTM F67-13 (Reapproved 2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
01/30/2014 Materials 8-344 Complete ISO 7153-1 Second edition 1991-04-01 Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)]
06/07/2018 Materials 8-337 Complete ASTM F621-12 (Reapproved 2017) Standard Specification for Stainless Steel Forgings for Surgical Implants
08/21/2017 Materials 8-333 Complete ASTM F2393-12 (Reapproved 2020) Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
08/21/2017 Materials 8-226 Complete ASTM F603-12 (Reapproved 2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
04/04/2016 Materials 8-200 Complete 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 Complete ASTM F2024-10 (Reapproved 2016) Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
01/14/2019 Materials 8-179 Partial 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 Complete ASTM F1609-08 (Reapproved 2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
01/30/2014 Materials 8-159 Complete 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 Complete 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 Complete 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 Complete ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
04/04/2016 Materials 8-136 Complete ASTM F2458-05 (Reapproved 2015) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
04/04/2016 Materials 8-135 Complete ASTM F2392-04 (Reapproved 2015) Standard Test Method for Burst Strength of Surgical Sealants
04/04/2016 Materials 8-116 Complete ASTM F2258-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
04/04/2016 Materials 8-115 Complete 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 Complete 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 Complete ASTM F1147-05 (Reapproved 2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
09/17/2018 Materials 8-112 Complete 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 Complete ASTM F746-04 (Reapproved 2014) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
12/18/2023 InVitro Diagnostics 7-320 Partial CLSI H62 1st Edition Validation of Assays Performed by Flow Cytometry
12/18/2023 InVitro Diagnostics 7-319 Complete CLSI M23 6th Edition Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters
12/18/2023 InVitro Diagnostics 7-318 Complete CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
05/29/2023 InVitro Diagnostics 7-317 Partial CLSI M100, 33rd Edition Performance Standards for Antimicrobial Susceptibility Testing
05/29/2023 InVitro Diagnostics 7-316 Complete CLSI NBS01 7th Edition Dried Blood Spot Specimen Collection for Newborn Screening
05/29/2023 InVitro Diagnostics 7-315 Complete CLSI EP12 3rd Edition Evaluation of Qualitative, Binary Output Examination Performance
12/19/2022 InVitro Diagnostics 7-314 Partial CLSI M27M44S, 3rd Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts
12/19/2022 InVitro Diagnostics 7-313 Complete CLSI EP27 2nd Edition Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
05/30/2022 InVitro Diagnostics 7-312 Complete CLSI M39 5th Edition Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
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
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 7-309 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
06/07/2021 InVitro Diagnostics 7-307 Complete CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring
06/07/2021 InVitro Diagnostics 7-306 Complete CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures
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 7-304 Complete CLSI M23 5th Edition Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
12/21/2020 InVitro Diagnostics 7-302 Complete CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride Analysis
12/21/2020 InVitro Diagnostics 7-301 Complete CLSI GP42 7th Edition Collection of Capillary Blood Specimens
12/21/2020 InVitro Diagnostics 7-300 Complete CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
12/21/2020 InVitro Diagnostics 7-299 Complete CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring
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
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
07/06/2020 InVitro Diagnostics 7-296 Partial CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
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.
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.
06/07/2021 InVitro Diagnostics 7-292 Partial CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
07/15/2019 InVitro Diagnostics 7-291 Partial CLSI EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
07/15/2019 InVitro Diagnostics 7-290 Partial CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
07/15/2019 InVitro Diagnostics 7-289 Partial CLSI MM17 2nd Edition Verification and Validation of Multiplex Nucleic Acid Assays
07/15/2019 InVitro Diagnostics 7-288 Complete CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
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
01/14/2019 InVitro Diagnostics 7-286 Complete CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
01/14/2019 InVitro Diagnostics 7-285 Complete CLSI M48-A 2nd Edition Laboratory Detection and Identification of Mycobacteria
09/17/2018 InVitro Diagnostics 7-284 Complete CLSI EP37 1st Edition Supplemental Tables for Interference Testing in Clinical Chemistry
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
09/17/2018 InVitro Diagnostics 7-280 Complete CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests
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 7-278 Complete CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
09/17/2018 InVitro Diagnostics 7-277 Complete CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens
09/17/2018 InVitro Diagnostics 7-276 Complete CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
09/17/2018 InVitro Diagnostics 7-275 Complete CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry.
08/21/2017 InVitro Diagnostics 7-273 Complete 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 Partial CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
08/21/2017 InVitro Diagnostics 7-270 Complete 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 Partial CLSI MM23-1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
12/23/2016 InVitro Diagnostics 7-268 Partial 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 Complete CLSI C24 4th Edition (Replaces C24-A3) Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
09/21/2016 InVitro Diagnostics 7-266 Complete 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 Partial CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
06/27/2016 InVitro Diagnostics 7-264 Partial CLSI MM21-1st Edition (Reaffirmed: January 2020) Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
06/07/2021 InVitro Diagnostics 7-262 Partial 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 Complete CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
04/04/2016 InVitro Diagnostics 7-259 Partial 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 Complete CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
08/14/2015 InVitro Diagnostics 7-255 Partial 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 Complete 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 Complete CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
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
01/27/2015 InVitro Diagnostics 7-250 Partial CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
01/30/2014 InVitro Diagnostics 7-244 Complete 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 Partial 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 Complete 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 Complete CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report
01/15/2013 InVitro Diagnostics 7-238 Complete CLSI MM06-A2 (Replaces MM06-A) Quantitative Molecular Methods for Infectious Diseases; 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
06/07/2021 InVitro Diagnostics 7-236 Partial CLSI M43-A October 2011 Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
01/15/2013 InVitro Diagnostics 7-235 Complete CLSI EP25-A (Replaces EP25-P) Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
08/06/2013 InVitro Diagnostics 7-234 Partial 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 Complete CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
01/14/2019 InVitro Diagnostics 7-232 Complete 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 Complete 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 Complete 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 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
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
01/30/2014 InVitro Diagnostics 7-220 Partial 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 Complete 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 Complete CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
 
 < 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 13 
 14 
 > 
 
-
-