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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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01/14/2019 Orthopedic 11-344 Complete ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
12/21/2020 Biocompatibility 2-283 Complete ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
07/06/2020 Orthopedic 11-368 Complete ASTM F3334-19 Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
12/21/2020 Orthopedic 11-372 Complete ASTM F2996-20 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
12/18/2023 Materials 8-610 Complete ASTM F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
01/14/2019 Materials 8-483 Complete ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
08/14/2015 Orthopedic 11-183 Complete ASTM F1875-98 (Reapproved 2022) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
07/06/2020 Orthopedic 11-369 Complete ASTM F3292-19 Standard Practice for Inspection of Spinal Implants Undergoing Testing
12/22/2025 Orthopedic 11-435 Complete ASTM F3292-25 Standard Practice for Inspection of Spinal Implants Undergoing Testing
05/25/2026 Materials 8-649 Complete ASTM F2503-26 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
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
07/06/2020 Materials 8-528 Complete ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
07/15/2019 Orthopedic 11-350 Complete ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
12/23/2024 Orthopedic 11-415 Complete ASTM F2554-22 Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems
12/23/2016 General I (QS/
RM)		 5-113 Complete ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
05/30/2022 Sterility 14-576 Complete ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
12/22/2025 Orthopedic 11-424 Complete ASTM F983-24 Standard Practice for Permanent Marking of Orthopaedic Implant Components
09/17/2018 Orthopedic 11-197 Complete ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
07/15/2019 Biocompatibility 2-267 Complete ASTM F2888-19 Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials.
12/21/2020 Materials 8-547 Complete ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
12/22/2025 Materials 8-641 Complete ASTM F629-24 Standard Practice for Radiography of Cast Metallic 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
06/27/2016 Materials 8-431 Complete ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
07/15/2019 Materials 8-504 Complete ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
12/22/2025 Biocompatibility 2-310 Complete ASTM F748-25 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
12/23/2016 Biocompatibility 2-244 Partial ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
12/19/2022 Biocompatibility 2-297 Complete ASTM F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
12/21/2020 Biocompatibility 2-280 Complete ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
12/20/2021 Materials 8-567 Complete ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
07/15/2019 Biocompatibility 2-263 Complete ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
12/22/2025 Biocompatibility 2-308 Complete ASTM F1984-25 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
01/14/2019 Biocompatibility 2-141 Complete ASTM F1984-99 (Reapproved 2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
09/17/2018 Biocompatibility 2-256 Complete ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
12/22/2025 Biocompatibility 2-312 Complete ASTM F720-24 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
12/21/2020 Biocompatibility 2-278 Complete ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
07/26/2016 Biocompatibility 2-213 Complete ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
12/23/2024 Materials 8-627 Complete ASTM F3604-23 Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion.
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
08/21/2017 Materials 8-458 Complete ASTM G5-14 Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
12/23/2024 Orthopedic 11-414 Complete ASTM F382-24 Standard Specification and Test Method for Metallic Bone Plates
09/17/2018 Orthopedic 11-333 Complete ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
12/22/2025 Orthopedic 11-438 Complete ASTM F2502-24 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
12/22/2025 Orthopedic 11-428 Complete ASTM F1541-24 Standard Specification and Test Methods for External Skeletal Fixation Devices
09/17/2018 Orthopedic 11-322 Complete ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
12/23/2016 Orthopedic 11-316 Complete ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
12/22/2025 Orthopedic 11-427 Complete ASTM F1264-24 Standard Specification and Test Methods for Intramedullary Fixation Devices
12/22/2025 Orthopedic 11-430 Complete ASTM F564-24 Standard Specification and Test Methods for Metallic Bone Staples
09/17/2018 Orthopedic 11-325 Complete ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
12/23/2024 Orthopedic 11-413 Complete ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws
 
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