|
|
|
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)
|
| 07/15/2019 |
Materials |
8-510 |
Complete |
ASTM |
F997-18 |
Standard Specification for Polycarbonate Resin for Medical Applications |
| 09/17/2018 |
Materials |
8-478 |
Complete |
ASTM |
F1089-18 |
Standard Test Method for Corrosion of Surgical Instruments |
| 05/29/2023 |
Materials |
8-597 |
Complete |
ASTM |
F2003-02(2022) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| 05/29/2023 |
Materials |
8-598 |
Complete |
ASTM |
F3109-22 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
| 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 |
| 05/30/2022 |
Materials |
8-587 |
Complete |
ISO |
5832-3 Fifth Edition 2021-11 |
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| 05/30/2022 |
Materials |
8-584 |
Complete |
ASTM |
F2146-22 |
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) |
| 05/30/2022 |
Materials |
8-585 |
Complete |
ASTM |
F1377-21 |
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538) |
| 05/30/2022 |
Materials |
8-586 |
Complete |
ASTM |
F2989-21 |
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-570 |
Complete |
ASTM |
F1108-21 |
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| 12/20/2021 |
Materials |
8-571 |
Complete |
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 |
8-591 |
Complete |
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) |
| 12/18/2023 |
Materials |
8-605 |
Complete |
ASTM |
F1609-23 |
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
| 01/14/2019 |
Materials |
8-482 |
Complete |
ASTM |
D1505-18 |
Standard Test Method for Density of Plastics by the Density-Gradient Technique |
| 12/20/2021 |
Materials |
8-577 |
Complete |
ISO |
13179-1 Second Edition 2021-09 |
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders |
| 12/20/2021 |
Materials |
8-579 |
Complete |
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)] |
| 01/27/2015 |
Materials |
8-171 |
Complete |
ASTM |
F1609-08 (Reapproved 2014) |
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
| 12/18/2023 |
Materials |
8-606 |
Complete |
ASTM |
F2537-23 |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
| 12/19/2022 |
Materials |
8-595 |
Complete |
ISO |
5832-5 Fourth Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel |
| 12/19/2022 |
Materials |
8-596 |
Complete |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 12/20/2021 |
Materials |
8-575 |
Complete |
ASTM |
F3160-21 |
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
| 12/20/2021 |
Materials |
8-576 |
Complete |
ASTM |
F451-21 |
Standard Specification for Acrylic Bone Cement |
| 04/04/2016 |
Materials |
8-400 |
Complete |
ASTM |
F1854-15 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
| 12/20/2021 |
Materials |
8-572 |
Complete |
ASTM |
F2565-21 |
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-573 |
Complete |
ASTM |
F2695-12(2025) |
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| 07/06/2020 |
Materials |
8-533 |
Complete |
ISO ASTM |
52907: First Edition 2019-11 |
Additive Manufacturing - Feedstock materials - Methods to characterize metal powders |
| 07/06/2020 |
Materials |
8-534 |
Complete |
ISO ASTM |
52911-1: First Edition 2019-07 |
Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals |
| 07/06/2020 |
Materials |
8-535 |
Complete |
ISO ASTM |
52911-2: First Edition 2019-09 |
Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers |
| 07/06/2020 |
Materials |
8-532 |
Complete |
ASTM |
F3335-20 |
Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion |
| 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 |
| 05/29/2023 |
Materials |
8-604 |
Complete |
ASTM |
F2257-22 |
Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673) |
| 05/29/2024 |
Materials |
8-617 |
Complete |
ISO ASTM |
52926-3 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 3: Qualification of operators for PBF-EB |
| 12/19/2022 |
Materials |
8-594 |
Complete |
ISO |
5832-6 Third Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy |
| 07/09/2014 |
Materials |
8-378 |
Complete |
ASTM |
D792-13 |
Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
| 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 |
| 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 |
| 06/07/2021 |
Materials |
8-557 |
Complete |
ASTM |
F3268-18a |
Standard Guide for in vitro Degradation Testing of Absorbable Metals |
| 05/30/2022 |
Materials |
8-590 |
Complete |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
| 12/20/2021 |
Materials |
8-564 |
Complete |
ASTM |
F2005-21 |
Standard Terminology for Nickel-Titanium Shape Memory Alloys |
| 12/20/2021 |
Materials |
8-565 |
Complete |
ASTM |
F2754/F2754M-21 |
Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire |
| 06/07/2021 |
Materials |
8-556 |
Complete |
ASTM |
F640-20 |
Standard Test Methods for Determining Radiopacity for Medical Use |
| 06/07/2021 |
Materials |
8-561 |
Complete |
ISO ASTM |
52950 First edition 2021-01 |
Additive manufacturing - General principles - Overview of data processing |
| 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 |
| 06/07/2021 |
Materials |
8-562 |
Complete |
ISO ASTM |
52904 First edition 2019-08 |
Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications |
| 12/21/2020 |
Materials |
8-549 |
Complete |
ASTM |
F3208-20 |
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
| 12/21/2020 |
Materials |
8-548 |
Complete |
ISO ASTM |
52915 Third edition 2020-03 |
Specification for additive manufacturing file format (AMF) Version 1.2 |
| 09/17/2018 |
Materials |
8-465 |
Complete |
ISO |
5832-2 Fourth edition 2018-03 |
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium |
| 12/20/2021 |
Materials |
8-578 |
Complete |
ASTM |
F2848-21 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| 12/21/2020 |
Materials |
8-551 |
Complete |
ASTM |
F2895-20 |
Standard Practice for Digital Radiography of Cast Metallic Implants |
| 12/22/2025 |
Materials |
8-645 |
Complete |
ASTM |
F1925-24 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 12/22/2025 |
Materials |
8-644 |
Complete |
ASTM |
F2848-25 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| 12/22/2025 |
Materials |
8-646 |
Complete |
ASTM |
F624-25 |
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Medical Applications |
| 05/25/2026 |
Materials |
8-647 |
Complete |
ASTM |
F3260-25 |
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| 12/22/2025 |
Materials |
8-641 |
Complete |
ASTM |
F629-24 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
| 12/21/2020 |
Materials |
8-547 |
Complete |
ASTM |
F629-20 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
| 12/22/2025 |
Materials |
8-642 |
Complete |
ASTM |
F2895-24 |
Standard Practice for Digital Radiography of Cast Metallic Implants |
| 12/23/2019 |
Materials |
8-491 |
Complete |
ASTM |
F1088-18 |
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| 07/06/2020 |
Materials |
8-526 |
Complete |
ASTM |
F2182-19e2 |
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance |
| 06/07/2021 |
Materials |
8-560 |
Complete |
ASTM |
D1415-18 |
Standard Test Method for Rubber Property - International Hardness |
| 12/21/2020 |
Materials |
8-550 |
Complete |
ASTM |
F2181-20 |
Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants |
| 12/21/2020 |
Materials |
8-553 |
Complete |
ISO ASTM |
52903-1 First edition 2020-04 |
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials |
| 08/21/2017 |
Materials |
8-455 |
Complete |
ASTM |
F2902-16 |
Standard Guide for Assessment of Absorbable Polymeric Implants |
| 05/30/2022 |
Materials |
8-589 |
Complete |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 12/22/2025 |
Materials |
8-634 |
Complete |
ASTM |
F2066-23 |
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
| 12/23/2019 |
Materials |
8-484 |
Complete |
ASTM |
F2066-18 |
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
| 05/29/2023 |
Materials |
8-602 |
Complete |
ASTM |
F2503-23 |
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| 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 |
| 12/22/2025 |
Materials |
8-633 |
Complete |
ASTM |
F2902-24 |
Standard Guide for Assessment of Absorbable Polymeric Implants |
| 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) |
| 07/15/2019 |
Materials |
8-514 |
Complete |
ISO |
5834-2 Fifth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms |
| 12/21/2020 |
Materials |
8-554 |
Complete |
ISO ASTM |
TR 52912 First edition 2020-09 |
Additive manufacturing - Design - Functionally graded additive manufacturing |
| 12/21/2020 |
Materials |
8-537 |
Complete |
ASTM |
F620-20 |
Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition |
| 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 |
| 12/21/2020 |
Materials |
8-545 |
Complete |
ASTM |
F2977-20 |
Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical 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 |
| 12/23/2019 |
Materials |
8-521 |
Complete |
ASTM |
F2313-18 |
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
| 06/27/2016 |
Materials |
8-431 |
Complete |
ASTM |
F2971-13 |
Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing |
| 08/06/2013 |
Materials |
8-153 |
Complete |
ASTM |
F2119-07 (Reapproved 2013) |
Standard Test Method for Evaluation of MR Image Artifacts from Passive 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) |
| 12/21/2020 |
Materials |
8-552 |
Complete |
ASTM |
F3434-20 |
Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing |
| 12/22/2025 |
Materials |
8-637 |
Complete |
ASTM |
F2579-24 |
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| 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 |
| 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 |
| 01/30/2014 |
Materials |
8-358 |
Complete |
ASTM |
F1855-00 (Reapproved 2019) |
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
| 12/22/2025 |
Materials |
8-631 |
Complete |
ASTM |
F1854-25 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants Using Digital Images |
| 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 |
| 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 |
8-136 |
Complete |
ASTM |
F2458-05 (Reapproved 2015) |
Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants |
| 12/23/2019 |
Materials |
8-519 |
Complete |
ISO |
13782 Second edition 2019-04 |
Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications |
| 04/04/2016 |
Materials |
8-404 |
Complete |
ASTM |
E647-15 |
Standard Test Method for Measurement of Fatigue Crack Growth Rates |
| 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 |
8-505 |
Complete |
ISO |
6474-2 Second edition 2019-03 |
Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement |
| 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 |
| 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 |
| 04/04/2016 |
Materials |
8-403 |
Complete |
ASTM |
D638-14 |
Standard Test Method for Tensile Properties of Plastics |
| 07/15/2019 |
Materials |
8-517 |
Complete |
ISO |
17327-1 First edition 2018-02 |
Non-active surgical implants - Implant coating - Part 1: General requirements |
| 12/22/2025 |
Materials |
8-640 |
Complete |
ASTM |
F961-25 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 12/22/2025 |
Materials |
8-643 |
Complete |
ASTM |
F2820-24 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-574 |
Complete |
ASTM |
F2820-12(2021)e1 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| 05/29/2024 |
Materials |
8-615 |
Complete |
ISO ASTM |
52926-1 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 1: General qualification of operators |
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