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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
03/16/2012 General Plastic Surgery/
General Hospital		 6-177 Complete ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
12/20/2021 Orthopedic 11-387 Complete ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
08/14/2015 General Plastic Surgery/
General Hospital		 6-200 Complete ASTM E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
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
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)
12/23/2019 Materials 8-520 Complete ASTM F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
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)
08/21/2017 General Plastic Surgery/
General Hospital		 6-124 Complete ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
06/07/2021 Materials 8-558 Complete ASTM F3333-20 Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
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 8-605 Complete ASTM F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
01/30/2014 General Plastic Surgery/
General Hospital		 6-117 Complete ASTM F2172-02 (Reapproved 2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
12/23/2019 Materials 8-491 Complete ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
12/19/2022 General Plastic Surgery/
General Hospital		 6-484 Complete ASTM F3502-22a Standard Specification for Barrier Face Coverings
08/14/2015 Orthopedic 11-294 Complete ASTM F1357-14 (Reapproved 2019) Standard Specification for Articulating Total Wrist Implants
05/29/2023 Orthopedic 11-399 Complete ASTM F1357-23 Standard Specification for Articulating Total Wrist Implants
12/23/2019 Materials 8-508 Complete ASTM F2579-18 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
06/07/2018 General Plastic Surgery/
General Hospital		 6-407 Complete ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products
04/04/2016 Materials 8-409 Partial ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
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
06/27/2016 Materials 8-426 Complete ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
12/20/2021 Materials 8-576 Complete ASTM F451-21 Standard Specification for Acrylic Bone Cement
04/04/2016 Orthopedic 11-301 Complete ASTM F2091-15 Standard Specification for Acetabular Prostheses
12/21/2020 Materials 8-544 Complete ASTM F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
09/17/2018 Orthopedic 11-327 Complete ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws
09/17/2018 Orthopedic 11-325 Complete ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
12/23/2016 Orthopedic 11-316 Complete ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
09/17/2018 Orthopedic 11-322 Complete ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
09/17/2018 Orthopedic 11-333 Complete ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
08/21/2017 Materials 8-458 Complete ASTM G5-14 Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
08/21/2017 Materials 8-195 Complete ASTM F2024-10 (Reapproved 2016) Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
07/26/2016 Biocompatibility 2-213 Complete ASTM F1904-14 Standard Practice for Testing the Biological Responses to Particles In Vivo
12/21/2020 Biocompatibility 2-278 Complete ASTM F719-20 e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
09/17/2018 Biocompatibility 2-256 Complete ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
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
07/15/2019 Biocompatibility 2-263 Complete ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
12/20/2021 Materials 8-567 Complete ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
12/21/2020 Biocompatibility 2-280 Complete ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
12/23/2016 Biocompatibility 2-93 Complete ASTM F763-04 (Reapproved 2016) Standard Practice for Short-Term Screening of Implant Materials
12/19/2022 Biocompatibility 2-297 Complete ASTM F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
12/23/2016 Biocompatibility 2-244 Partial ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
07/15/2019 Materials 8-504 Complete ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
09/09/2008 Software/
Informatics		 13-21 Complete CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems
06/27/2016 Materials 8-431 Complete ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
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
12/21/2020 Materials 8-547 Complete ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
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.
09/17/2018 Orthopedic 11-197 Complete ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
 
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