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U.S. Department of Health and Human Services

Recognized Consensus Standards
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04/04/2016 Materials 8-409 ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
09/17/2018 Materials 8-412 ASTM F2537-06 (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
04/04/2016 Materials 8-413 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 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 8-421 ASTM F629-15 Standard Practice for Radiography of Cast Metallic Surgical Implants
06/27/2016 Materials 8-426 ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
06/27/2016 Materials 8-427 ASTM F1185-03 (Reapproved 2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants
08/21/2017 Materials 8-428 ASTM F1581-08 (Reapproved 2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
06/27/2016 Materials 8-429 ASTM F2224-09 (Reapproved 2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
06/27/2016 Materials 8-430 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 ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
06/27/2016 Materials 8-432 ASTM ISO 52921 First Edition 2013-06-01 Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies.
06/27/2016 Materials 8-434 ASTM ISO 52900 First Edition 2015-12-15 Additive manufacturing -- General principles - Terminology
12/23/2016 Materials 8-435 ISO 5832-1 Fifth edition 2016-07-15 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
12/23/2016 Materials 8-437 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 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 ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
12/23/2016 Materials 8-441 ASTM F3109-16 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
12/23/2016 Materials 8-442 ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
12/23/2016 Materials 8-444 ISO 17296-2 First edition 2015-01-15 Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock
08/21/2017 Materials 8-447 ISO 5832-3 Fourth edition 2016-10-15 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
08/21/2017 Materials 8-449 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 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 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 ASTM F1295-16 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
08/21/2017 Materials 8-455 ASTM F2902-16 Standard Guide for Assessment of Absorbable Polymeric Implants
08/21/2017 Materials 8-457 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 ASTM G5-14 Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
08/21/2017 Materials 8-459 SAE /AMS2750 Rev. E 2012-07 Pyrometry
06/07/2018 Materials 8-463 ASTM ISO 52901 First edition 2017-08 Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts
06/07/2018 Materials 8-464 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 ISO 5832-2 Fourth edition 2018-03 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
09/17/2018 Materials 8-466 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 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 ASTM F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
09/17/2018 Materials 8-469 ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
09/17/2018 Materials 8-470 ASTM F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
09/17/2018 Materials 8-471 ASTM F1925-17 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
09/17/2018 Materials 8-472 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 ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
09/17/2018 Materials 8-474 ASTM F2886-17 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
09/17/2018 Materials 8-475 ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
09/17/2018 Materials 8-476 ASTM F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
09/17/2018 Materials 8-478 ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments
09/17/2018 Materials 8-479 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 ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
12/23/2019 Materials 8-481 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 ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique
01/14/2019 Materials 8-483 ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
12/23/2019 Materials 8-484 ASTM F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
01/14/2019 Materials 8-485 ASTM F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
01/14/2019 Materials 8-487 ASTM ISO 52910-18 Additive manufacturing - Design - Requirements, guidelines and recommendations
01/14/2019 Materials 8-488 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 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 ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
12/23/2019 Materials 8-492 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 ISO 13779-2 Third edition 2018-12 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
12/23/2019 Materials 8-494 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 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 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 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 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 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 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 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 ASTM F2038-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
07/15/2019 Materials 8-503 ASTM F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication
07/15/2019 Materials 8-504 ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
12/23/2019 Materials 8-505 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 8-506 ASTM F2516-18 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
12/23/2019 Materials 8-507 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 8-508 ASTM F2579-18 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
07/15/2019 Materials 8-509 ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
07/15/2019 Materials 8-510 ASTM F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
07/15/2019 Materials 8-513 ISO 20160 First edition 2006-05-01 Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
07/15/2019 Materials 8-514 ISO 5834-2 Fifth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
07/15/2019 Materials 8-516 ISO 13779-4 Second edition 2018-12 Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
07/15/2019 Materials 8-517 ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1: General requirements
07/15/2019 Materials 8-518 ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants
12/23/2019 Materials 8-519 ISO 13782 Second edition 2019-04 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
12/23/2019 Materials 8-520 ASTM F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
12/23/2019 Materials 8-521 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
12/23/2019 Materials 8-522 ASTM F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
12/23/2019 Materials 8-523 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 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
07/06/2020 Materials 8-525 ISO TS 17137 Second edition 2019-09 Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
07/06/2020 Materials 8-526 ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance
07/06/2020 Materials 8-527 ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments
07/06/2020 Materials 8-528 ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
07/06/2020 Materials 8-529 ASTM F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
07/06/2020 Materials 8-531 ASTM F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
07/06/2020 Materials 8-532 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 8-533 ASTM ISO 52907: First Edition 2019-11 Additive Manufacturing - Feedstock materials - Methods to characterize metal powders
07/06/2020 Materials 8-534 ASTM ISO 52911-1: First Edition 2019-07 Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals
07/06/2020 Materials 8-535 ASTM ISO 52911-2: First Edition 2019-09 Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers
07/06/2020 Materials 8-536 ASTM ISO 52902:First Edition 2019-07 Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
12/21/2020 Materials 8-537 ASTM F620-20 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
12/21/2020 Materials 8-538 ASTM F2759-19 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
12/21/2020 Materials 8-539 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 8-540 ASTM F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
 
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