|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 09/17/2018 |
Materials |
8-476 |
ASTM |
F2004-17 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
| 09/17/2018 |
Materials |
8-479 |
ISO |
13781 Second edition 2017-07 |
Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing |
| 12/20/2021 |
Materials |
8-568 |
ASTM |
F1586-21 |
Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) |
| 06/07/2018 |
Materials |
8-337 |
ASTM |
F621-12 (Reapproved 2017) |
Standard Specification for Stainless Steel Forgings for Surgical Implants |
| 06/07/2018 |
Materials |
8-356 |
ASTM |
F67-13 (Reapproved 2017) |
Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) |
| 08/21/2017 |
Materials |
8-455 |
ASTM |
F2902-16 |
Standard Guide for Assessment of Absorbable Polymeric Implants |
| 04/04/2016 |
Materials |
8-415 |
ASTM |
F2778-09 (Reapproved 2020) |
Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR) |
| 08/21/2017 |
Materials |
8-453 |
ASTM |
F1295-16 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
| 04/04/2016 |
Materials |
8-136 |
ASTM |
F2458-05 (Reapproved 2015) |
Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants |
| 09/17/2018 |
Materials |
8-471 |
ASTM |
F1925-17 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 05/30/2022 |
Materials |
8-592 |
ASTM |
F3384-21 |
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
| 05/30/2022 |
Materials |
8-589 |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 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 |
8-115 |
ASTM |
F2256-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading |
| 04/04/2016 |
Materials |
8-404 |
ASTM |
E647-15 |
Standard Test Method for Measurement of Fatigue Crack Growth Rates |
| 04/04/2016 |
Materials |
8-406 |
ISO |
5832-11 Second edition 2014-09-15 |
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
| 09/17/2018 |
Materials |
8-412 |
ASTM |
F2537-06 (Reapproved 2017) |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
| 08/06/2013 |
Materials |
8-336 |
ASTM |
F562-13 |
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
| 05/30/2022 |
Materials |
8-584 |
ASTM |
F2146-22 |
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) |
| 01/30/2014 |
Materials |
8-347 |
ASTM |
F2146-13 |
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) |
| 12/23/2016 |
Materials |
8-444 |
ISO |
17296-2 First edition 2015-01-15 |
Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock |
| 01/30/2014 |
Materials |
8-354 |
ASTM |
F1377-13 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
| 05/30/2022 |
Materials |
8-586 |
ASTM |
F2989-21 |
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-570 |
ASTM |
F1108-21 |
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| 12/20/2021 |
Materials |
8-571 |
ASTM |
F2052-21 |
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| 05/30/2022 |
Materials |
8-585 |
ASTM |
F1377-21 |
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538) |
| 12/20/2021 |
Materials |
8-566 |
ASTM |
F1813-21 |
Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120) |
| 12/20/2021 |
Materials |
8-564 |
ASTM |
F2005-21 |
Standard Terminology for Nickel-Titanium Shape Memory Alloys |
| 12/20/2021 |
Materials |
8-565 |
ASTM |
F2754/F2754M-21 |
Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire |
| 05/30/2022 |
Materials |
8-590 |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
| 05/30/2022 |
Materials |
8-591 |
ASTM |
F2229-21 |
Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108) |
| 12/20/2021 |
Materials |
8-563 |
ASTM |
F1801-20 |
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
| 05/30/2022 |
Materials |
8-593 |
ISO |
13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 |
Implants for surgery - Hydroxyapatite - Part 6: Powders |
| 12/23/2016 |
Materials |
8-442 |
ASTM |
F3127-16 |
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
| 09/17/2018 |
Materials |
8-478 |
ASTM |
F1089-18 |
Standard Test Method for Corrosion of Surgical Instruments |
| 06/27/2016 |
Materials |
8-431 |
ASTM |
F2971-13 |
Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing |
| 08/06/2013 |
Materials |
8-153 |
ASTM |
F2119-07 (Reapproved 2013) |
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
| 12/20/2021 |
Materials |
8-572 |
ASTM |
F2565-21 |
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| 05/30/2022 |
Materials |
8-588 |
ASTM |
F560-22 |
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
| 08/21/2017 |
Materials |
8-447 |
ISO |
5832-3 Fourth edition 2016-10-15 |
Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| 01/30/2014 |
Materials |
8-362 |
ASTM |
F2989-13 |
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
| 05/30/2022 |
Materials |
8-587 |
ISO |
5832-3 Fifth Edition 2021-11 |
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| 04/04/2016 |
Materials |
8-413 |
ASTM |
F2819-10 (Reapproved 2015) |
Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices |
| 12/20/2021 |
Materials |
8-578 |
ASTM |
F2848-21 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| 12/20/2021 |
Materials |
8-579 |
ISO |
13779-3 Second Edition 2018-12 |
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] |
| 09/09/2008 |
Materials |
8-61 |
ISO |
5832-6:1997 |
Implants for surgery -- Metallic materials -- Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy |
| 12/19/2022 |
Materials |
8-595 |
ISO |
5832-5 Fourth Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel |
| 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 |
| 06/07/2021 |
Materials |
8-556 |
ASTM |
F640-20 |
Standard Test Methods for Determining Radiopacity for Medical Use |
| 06/07/2021 |
Materials |
8-561 |
ASTM ISO |
52950 First edition 2021-01 |
Additive manufacturing - General principles - Overview of data processing |
| 07/09/2014 |
Materials |
8-377 |
ASTM |
F136-13 |
Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
| 04/04/2016 |
Materials |
8-393 |
ASTM |
F1350-15 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) |
| 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 |
| 08/21/2017 |
Materials |
8-449 |
ASTM |
F1058-16 |
Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008) |
| 09/17/2018 |
Materials |
8-473 |
ASTM |
F2885-17 |
Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications |
| 07/15/2019 |
Materials |
8-496 |
ISO |
5834-4 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method |
| 07/15/2019 |
Materials |
8-497 |
ISO |
5834-5 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method |
| 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 |
| 12/21/2020 |
Materials |
8-543 |
ASTM |
F755-19 |
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| 04/04/2016 |
Materials |
8-409 |
ASTM |
F2924-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion |
| 07/06/2020 |
Materials |
8-525 |
ISO |
TS 17137 Second edition 2019-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
| 12/23/2016 |
Materials |
8-439 |
ASTM |
F3001-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion |
| 06/07/2021 |
Materials |
8-562 |
ASTM ISO |
52904 First edition 2019-08 |
Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications |
| 04/04/2016 |
Materials |
8-394 |
ASTM |
F1472-14 |
Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| 06/07/2021 |
Materials |
8-559 |
ASTM |
D412-16e1 |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 07/15/2019 |
Materials |
8-517 |
ISO |
17327-1 First edition 2018-02 |
Non-active surgical implants - Implant coating - Part 1: General requirements |
| 01/30/2014 |
Materials |
8-348 |
ASTM |
F138-13 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 12/21/2020 |
Materials |
8-544 |
ASTM |
F961-20 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 12/23/2019 |
Materials |
8-491 |
ASTM |
F1088-18 |
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| 07/06/2020 |
Materials |
8-526 |
ASTM |
F2182-19e2 |
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance |
| 12/21/2020 |
Materials |
8-539 |
ASTM |
F139-19 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) |
| 12/20/2021 |
Materials |
8-575 |
ASTM |
F3160-21 |
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
| 07/15/2019 |
Materials |
8-516 |
ISO |
13779-4 Second edition 2018-12 |
Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength |
| 06/07/2021 |
Materials |
8-558 |
ASTM |
F3333-20 |
Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 12/21/2020 |
Materials |
8-551 |
ASTM |
F2895-20 |
Standard Practice for Digital Radiography of Cast Metallic Implants |
| 12/21/2020 |
Materials |
8-553 |
ASTM ISO |
52903-1 First edition 2020-04 |
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials |
| 01/14/2019 |
Materials |
8-485 |
ASTM |
F3260-18 |
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| 06/07/2021 |
Materials |
8-555 |
ASTM |
F1472-20a |
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| 07/15/2019 |
Materials |
8-495 |
ISO |
5834-3 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods |
| 06/07/2021 |
Materials |
8-560 |
ASTM |
D1415-18 |
Standard Test Method for Rubber Property - International Hardness |
| 12/19/2022 |
Materials |
8-596 |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 12/21/2020 |
Materials |
8-542 |
ASTM |
F138-19 |
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 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 |
| 12/21/2020 |
InVitro Diagnostics |
7-299 |
CLSI |
POCT14 2nd Edition |
Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
| 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. |
| 01/27/2015 |
InVitro Diagnostics |
7-250 |
CLSI |
M40-A2 (Reaffirmed: September 2019) |
Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition. |
| 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 |
| 07/15/2019 |
InVitro Diagnostics |
7-291 |
CLSI |
EP27-A |
How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st 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 |
| 06/27/2016 |
InVitro Diagnostics |
7-264 |
CLSI |
MM21-1st Edition (Reaffirmed: January 2020) |
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications |
| 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 |
| 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 |
| 12/19/2022 |
InVitro Diagnostics |
7-314 |
CLSI |
M27M44S, 3rd Edition |
Performance Standards for Antifungal Susceptibility Testing of Yeasts |
| 08/21/2017 |
InVitro Diagnostics |
7-272 |
CLSI |
C57 1st Edition (Reaffirmed: January 2020) |
Mass Spectrometry for Androgen and Estrogen Measurements in Serum |
| 09/21/2016 |
InVitro Diagnostics |
7-265 |
CLSI |
C62-A |
Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. |
| 01/30/2014 |
InVitro Diagnostics |
7-210 |
CLSI |
H26-A2 |
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition |
| 07/06/2020 |
InVitro Diagnostics |
7-296 |
CLSI |
EP09c 3rd Edition |
Measurement Procedure Comparison and Bias Estimation Using Patient Samples |
| 06/07/2021 |
InVitro Diagnostics |
7-236 |
CLSI |
M43-A October 2011 |
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline |
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