|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
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 |