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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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12/21/2020 Materials 8-548 Complete ISO ASTM 52915 Third edition 2020-03 Specification for additive manufacturing file format (AMF) Version 1.2
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
07/15/2019 Materials 8-509 Complete ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
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
09/17/2018 Materials 8-473 Partial ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
07/15/2019 Materials 8-504 Complete ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
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
12/20/2021 Materials 8-574 Complete ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
12/21/2020 Materials 8-547 Complete ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
06/07/2021 Materials 8-555 Complete ASTM F1472-20a Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
06/07/2021 Materials 8-557 Complete ASTM F3268-18a Standard Guide for in vitro Degradation Testing of Absorbable Metals
12/21/2020 Materials 8-545 Complete ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
07/15/2019 Materials 8-516 Complete ISO 13779-4 Second edition 2018-12 Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
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
07/15/2019 Materials 8-517 Complete ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1: General requirements
07/06/2020 Materials 8-536 Complete ISO ASTM 52902:First Edition 2019-07 Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
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
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 8-498 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
07/15/2019 Materials 8-510 Complete ASTM F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
01/14/2019 Materials 8-482 Complete ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique
07/06/2020 Materials 8-531 Complete ASTM F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
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
07/09/2014 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)]
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
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
07/15/2019 Materials 8-503 Complete ASTM F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication
07/06/2020 Materials 8-527 Complete ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments
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 8-578 Complete ASTM F2848-21 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
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)]
12/21/2020 Materials 8-554 Complete ISO ASTM TR 52912 First edition 2020-09 Additive manufacturing - Design - Functionally graded additive manufacturing
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
12/21/2020 Materials 8-537 Complete ASTM F620-20 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
07/15/2019 Materials 8-513 Complete ISO 20160 First edition 2006-05-01 Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
12/21/2020 Materials 8-538 Complete ASTM F2759-19 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
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)
12/23/2019 Materials 8-484 Complete ASTM F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
12/21/2020 Materials 8-539 Complete ASTM F139-19 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
12/21/2020 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
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 8-523 Complete ASTM F3275-19 Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
12/23/2019 Materials 8-524 Complete ASTM F3276-19 Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
12/23/2019 Materials 8-519 Complete ISO 13782 Second edition 2019-04 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
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)
12/21/2020 Materials 8-546 Complete ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
12/21/2020 Materials 8-544 Complete ASTM F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
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
12/23/2019 Materials 8-502 Complete ASTM F2038-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
12/23/2019 Materials 8-507 Complete ASTM F688-19 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
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
07/06/2020 Materials 8-529 Complete ASTM F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
12/20/2021 Materials 8-575 Complete ASTM F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
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 8-572 Complete ASTM F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
08/21/2017 Materials 8-455 Complete ASTM F2902-16 Standard Guide for Assessment of Absorbable Polymeric Implants
01/14/2019 Materials 8-487 Complete ISO ASTM 52910-18 Additive manufacturing - Design - Requirements, guidelines and recommendations
05/29/2023 Materials 8-598 Complete ASTM F3109-22 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
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 8-403 Complete ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
04/04/2016 Materials 8-408 Complete ASTM F3122-14 Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes
12/18/2023 Materials 8-606 Complete ASTM F2537-23 Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
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 8-532 Complete ASTM F3335-20 Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
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
12/23/2019 Materials 8-522 Complete ASTM F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
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
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)
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 8-116 Complete ASTM F2258-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
08/21/2017 Materials 8-428 Complete ASTM F1581-08 (Reapproved 2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
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
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
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 8-112 Complete ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
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
07/15/2019 Materials 8-518 Complete ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants
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
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 8-380 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
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
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)
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 8-399 Complete ASTM F90-14 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
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
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
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 8-401 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 8-405 Complete ISO 5832-4 Third edition 2014-09-15 Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
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 8-368 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)
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
 
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