|
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)
|
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 |
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 |
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 |
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 |
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 |
8-116 |
Complete |
ASTM |
F2258-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Tension |
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 |
8-136 |
Complete |
ASTM |
F2458-05 (Reapproved 2015) |
Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants |
08/06/2013 |
Materials |
8-153 |
Complete |
ASTM |
F2119-07 (Reapproved 2013) |
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
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 |
8-158 |
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 |
8-159 |
Complete |
ISO |
9584 First edition 1993-10-15 |
Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants |
01/27/2015 |
Materials |
8-171 |
Complete |
ASTM |
F1609-08 (Reapproved 2014) |
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
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 |
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 |
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 |
8-226 |
Complete |
ASTM |
F603-12 (Reapproved 2020) |
Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application |
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 |
06/07/2018 |
Materials |
8-337 |
Complete |
ASTM |
F621-12 (Reapproved 2017) |
Standard Specification for Stainless Steel Forgings for Surgical Implants |
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 |
8-356 |
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 |
8-358 |
Complete |
ASTM |
F1855-00 (Reapproved 2019) |
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
12/23/2016 |
Materials |
8-368 |
Complete |
ASTM |
F2625-10 (Reapproved 2016) |
Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry |
07/09/2014 |
Materials |
8-377 |
Complete |
ASTM |
F136-13 |
Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
07/09/2014 |
Materials |
8-378 |
Complete |
ASTM |
D792-13 |
Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
07/09/2014 |
Materials |
8-379 |
Complete |
ISO |
11542-2 First edition 1998-11-15 |
Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)] |
09/17/2018 |
Materials |
8-380 |
Complete |
ASTM |
F1160-14 (Reapproved 2017)e1 |
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
01/27/2015 |
Materials |
8-383 |
Complete |
ASTM |
F1926/F1926M-14 |
Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings |
08/14/2015 |
Materials |
8-389 |
Complete |
ISO |
15309 First edition 2013-12-01 |
Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices |
04/04/2016 |
Materials |
8-393 |
Complete |
ASTM |
F1350-15 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) |
04/04/2016 |
Materials |
8-394 |
Complete |
ASTM |
F1472-14 |
Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
04/04/2016 |
Materials |
8-399 |
Complete |
ASTM |
F90-14 |
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
04/04/2016 |
Materials |
8-400 |
Complete |
ASTM |
F1854-15 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
04/04/2016 |
Materials |
8-401 |
Complete |
ASTM |
F2118-14 (Reapproved 2020) |
Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials |
04/04/2016 |
Materials |
8-403 |
Complete |
ASTM |
D638-14 |
Standard Test Method for Tensile Properties of Plastics |
04/04/2016 |
Materials |
8-404 |
Complete |
ASTM |
E647-15 |
Standard Test Method for Measurement of Fatigue Crack Growth Rates |
04/04/2016 |
Materials |
8-405 |
Complete |
ISO |
5832-4 Third edition 2014-09-15 |
Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy |
04/04/2016 |
Materials |
8-406 |
Complete |
ISO |
5832-11 Second edition 2014-09-15 |
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
04/04/2016 |
Materials |
8-408 |
Complete |
ASTM |
F3122-14 |
Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes |
04/04/2016 |
Materials |
8-409 |
Partial |
ASTM |
F2924-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion |
09/17/2018 |
Materials |
8-412 |
Complete |
ASTM |
F2537-06 (Reapproved 2017) |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
04/04/2016 |
Materials |
8-413 |
Complete |
ASTM |
F2819-10 (Reapproved 2015) |
Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices |
04/04/2016 |
Materials |
8-415 |
Complete |
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) |
06/27/2016 |
Materials |
8-426 |
Complete |
ASTM |
F3087-15 |
Standard Specification for Acrylic Molding Resins for Medical Implant Applications |
06/27/2016 |
Materials |
8-427 |
Complete |
ASTM |
F1185-03 (Reapproved 2014) |
Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
08/21/2017 |
Materials |
8-428 |
Complete |
ASTM |
F1581-08 (Reapproved 2020) |
Standard Specification for Composition of Anorganic Bone for Surgical Implants |
06/27/2016 |
Materials |
8-429 |
Complete |
ASTM |
F2224-09 (Reapproved 2020) |
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
06/27/2016 |
Materials |
8-430 |
Complete |
ISO |
13356:2015 Third Edition 2015-09-15 |
Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
06/27/2016 |
Materials |
8-431 |
Complete |
ASTM |
F2971-13 |
Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing |
06/27/2016 |
Materials |
8-432 |
Complete |
ISO ASTM |
52921 First Edition 2013-06-01 |
Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies. |
06/27/2016 |
Materials |
8-434 |
Complete |
ISO ASTM |
52900 First Edition 2015-12-15 |
Additive manufacturing -- General principles - Terminology |
12/23/2016 |
Materials |
8-435 |
Complete |
ISO |
5832-1 Fifth edition 2016-07-15 |
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
12/23/2016 |
Materials |
8-437 |
Complete |
ASTM |
F2082/F2082M-16 |
Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery |
12/23/2016 |
Materials |
8-439 |
Partial |
ASTM |
F3001-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion |
12/23/2016 |
Materials |
8-440 |
Complete |
ASTM |
F3091/F3091M-14 |
Standard Specification for Powder Bed Fusion of Plastic Materials |
12/23/2016 |
Materials |
8-441 |
Complete |
ASTM |
F3109-16 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
12/23/2016 |
Materials |
8-442 |
Complete |
ASTM |
F3127-16 |
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
12/23/2016 |
Materials |
8-444 |
Complete |
ISO |
17296-2 First edition 2015-01-15 |
Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock |
08/21/2017 |
Materials |
8-449 |
Complete |
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) |
08/21/2017 |
Materials |
8-451 |
Complete |
ASTM |
F2214-16 |
Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
08/21/2017 |
Materials |
8-452 |
Complete |
ASTM |
F1635-16 |
Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
08/21/2017 |
Materials |
8-453 |
Complete |
ASTM |
F1295-16 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
08/21/2017 |
Materials |
8-455 |
Complete |
ASTM |
F2902-16 |
Standard Guide for Assessment of Absorbable Polymeric Implants |
08/21/2017 |
Materials |
8-457 |
Complete |
ISO |
13175-3 First edition 2012-10-01 |
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes |
08/21/2017 |
Materials |
8-458 |
Complete |
ASTM |
G5-14 |
Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements |
08/21/2017 |
Materials |
8-459 |
Complete |
SAE |
AMS2750 Rev. E 2012-07 |
Pyrometry |
06/07/2018 |
Materials |
8-463 |
Complete |
ISO ASTM |
52901 First edition 2017-08 |
Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts |
06/07/2018 |
Materials |
8-464 |
Complete |
ISO |
TS 10974 Second edition 2018 |
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
09/17/2018 |
Materials |
8-465 |
Complete |
ISO |
5832-2 Fourth edition 2018-03 |
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium |
09/17/2018 |
Materials |
8-466 |
Complete |
ASTM |
F2213-17 |
Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
09/17/2018 |
Materials |
8-467 |
Complete |
ASTM |
F1978-18 |
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser |
09/17/2018 |
Materials |
8-468 |
Complete |
ASTM |
F2459-18 |
Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis |
09/17/2018 |
Materials |
8-470 |
Complete |
ASTM |
F2102-17 |
Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants |
09/17/2018 |
Materials |
8-472 |
Complete |
ASTM |
F2847-17 |
Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments |
09/17/2018 |
Materials |
8-473 |
Partial |
ASTM |
F2885-17 |
Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications |
09/17/2018 |
Materials |
8-474 |
Complete |
ASTM |
F2886-17 |
Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications |
09/17/2018 |
Materials |
8-475 |
Complete |
ASTM |
F2026-17 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
09/17/2018 |
Materials |
8-476 |
Complete |
ASTM |
F2004-17 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
09/17/2018 |
Materials |
8-478 |
Complete |
ASTM |
F1089-18 |
Standard Test Method for Corrosion of Surgical Instruments |
09/17/2018 |
Materials |
8-479 |
Complete |
ISO |
13781 Second edition 2017-07 |
Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing |
12/23/2019 |
Materials |
8-480 |
Complete |
ASTM |
F2063-18 |
Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants |
12/23/2019 |
Materials |
8-481 |
Complete |
ASTM |
F1314-18 |
Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) |
01/14/2019 |
Materials |
8-482 |
Complete |
ASTM |
D1505-18 |
Standard Test Method for Density of Plastics by the Density-Gradient Technique |
01/14/2019 |
Materials |
8-483 |
Complete |
ASTM |
F601-18 |
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
12/23/2019 |
Materials |
8-484 |
Complete |
ASTM |
F2066-18 |
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
01/14/2019 |
Materials |
8-485 |
Complete |
ASTM |
F3260-18 |
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
01/14/2019 |
Materials |
8-487 |
Complete |
ISO ASTM |
52910-18 |
Additive manufacturing - Design - Requirements, guidelines and recommendations |
01/14/2019 |
Materials |
8-488 |
Complete |
ASTM |
F3301-18a |
Standard for Additive Manufacturing - Post Processing Methods - Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion |
01/14/2019 |
Materials |
8-489 |
Complete |
ASTM |
F3302-18 |
Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion |
12/23/2019 |
Materials |
8-491 |
Complete |
ASTM |
F1088-18 |
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
12/23/2019 |
Materials |
8-492 |
Complete |
ISO |
5832-9 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
07/15/2019 |
Materials |
8-493 |
Complete |
ISO |
13779-2 Third edition 2018-12 |
Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite |
12/23/2019 |
Materials |
8-494 |
Complete |
ISO |
6474-1 Second edition 2019-03 |
Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina |
07/15/2019 |
Materials |
8-495 |
Complete |
ISO |
5834-3 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods |
07/15/2019 |
Materials |
8-496 |
Complete |
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 |
Complete |
ISO |
5834-5 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method |
12/23/2019 |
Materials |
8-498 |
Complete |
ASTM |
F75-18 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
12/23/2019 |
Materials |
8-499 |
Complete |
ASTM |
F1580-18 |
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
12/23/2019 |
Materials |
8-500 |
Complete |
ISO |
5832-12 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy |
12/23/2019 |
Materials |
8-501 |
Complete |
ISO |
5834-1 Fourth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form |