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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
01/14/2019 Materials 8-485 ASTM F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
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 8-483 ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
01/14/2019 Materials 8-482 ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique
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)
12/23/2019 Materials 8-480 ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
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
09/17/2018 Materials 8-478 ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments
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 8-475 ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers 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 8-473 ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
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 8-471 ASTM F1925-17 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
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 8-469 ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
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 8-467 ASTM F1978-18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
09/17/2018 Materials 8-466 ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
09/17/2018 Materials 8-465 ISO 5832-2 Fourth edition 2018-03 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
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
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 8-460 ASTM F2848-17 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
08/21/2017 Materials 8-459 SAE /AMS2750 Rev. E 2012-07 Pyrometry
08/21/2017 Materials 8-458 ASTM G5-14 Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
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 8-456 ISO 13179-1 First edition 2014-06-01 Implants for surgery--Plasma-sprayed unalloyed titanium coatings on metallic surgical implants -- Part 1: General requirements
08/21/2017 Materials 8-455 ASTM F2902-16 Standard Guide for Assessment of Absorbable Polymeric 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 8-452 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 8-451 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 8-450 ASTM F451-16 Standard Specification for Acrylic Bone Cement
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 8-447 ISO 5832-3 Fourth edition 2016-10-15 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
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
12/23/2016 Materials 8-443 ASTM F3160-16 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
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 8-441 ASTM F3109-16 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
12/23/2016 Materials 8-440 ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
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 8-437 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 8-435 ISO 5832-1 Fifth edition 2016-07-15 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
06/27/2016 Materials 8-434 ASTM ISO 52900 First Edition 2015-12-15 Additive manufacturing -- General principles - Terminology
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 8-431 ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
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 8-429 ASTM F2224-09 (Reapproved 2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate 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 8-427 ASTM F1185-03 (Reapproved 2014) Standard Specification for Composition of Hydroxylapatite for 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 8-425 ASTM F2820-12 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
06/27/2016 Materials 8-424 ASTM F2695-12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
06/27/2016 Materials 8-423 ASTM F2565-13 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
06/27/2016 Materials 8-422 ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
06/27/2016 Materials 8-421 ASTM F629-15 Standard Practice for Radiography of Cast Metallic Surgical Implants
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)
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
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 8-409 ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
04/04/2016 Materials 8-408 ASTM F3122-14 Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes
04/04/2016 Materials 8-406 ISO 5832-11 Second edition 2014-09-15 Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
04/04/2016 Materials 8-405 ISO 5832-4 Third edition 2014-09-15 Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
04/04/2016 Materials 8-404 ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth Rates
04/04/2016 Materials 8-403 ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
04/04/2016 Materials 8-401 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 8-400 ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
04/04/2016 Materials 8-399 ASTM F90-14 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
04/04/2016 Materials 8-398 ASTM F1108-14 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
04/04/2016 Materials 8-394 ASTM F1472-14 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
04/04/2016 Materials 8-393 ASTM F1350-15 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
08/14/2015 Materials 8-391 ASTM F2313-10 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70% Glycolide
08/14/2015 Materials 8-389 ISO 15309 First edition 2013-12-01 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
01/27/2015 Materials 8-385 ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
01/27/2015 Materials 8-383 ASTM F1926/F1926M-14 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
09/17/2018 Materials 8-380 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
07/09/2014 Materials 8-379 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)]
07/09/2014 Materials 8-378 ASTM D792-13 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
07/09/2014 Materials 8-377 ASTM F136-13 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
07/09/2014 Materials 8-374 ASTM F2633-13 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
12/23/2016 Materials 8-368 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
01/30/2014 Materials 8-362 ASTM F2989-13 Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
01/30/2014 Materials 8-358 ASTM F1855-00 (Reapproved 2019) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
06/07/2018 Materials 8-356 ASTM F67-13 (Reapproved 2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
01/30/2014 Materials 8-355 ASTM F1586/F1586M-13 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
01/30/2014 Materials 8-354 ASTM F1377-13 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
01/30/2014 Materials 8-353 ASTM F86-13 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
01/30/2014 Materials 8-348 ASTM F138-13 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
01/30/2014 Materials 8-347 ASTM F2146-13 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
01/30/2014 Materials 8-346 ASTM F1813-13 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
01/30/2014 Materials 8-344 ISO 7153-1 Second edition 1991-04-01 Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)]
08/06/2013 Materials 8-343 ASTM F899-12b Standard Specification for Wrought Stainless Steels for Surgical Instruments
08/06/2013 Materials 8-342 ASTM F1537-11 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
08/06/2013 Materials 8-339 ASTM F1091-12 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
08/06/2013 Materials 8-338 ASTM F139-12 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
06/07/2018 Materials 8-337 ASTM F621-12 (Reapproved 2017) Standard Specification for Stainless Steel Forgings for Surgical Implants
08/06/2013 Materials 8-336 ASTM F562-13 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
08/21/2017 Materials 8-333 ASTM F2393-12 (Reapproved 2020) Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
08/21/2017 Materials 8-226 ASTM F603-12 (Reapproved 2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
01/30/2014 Materials 8-218 ASTM F799-11 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
06/27/2016 Materials 8-217 ASTM F620-11 (Reapproved 2015) Standard Specification Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
 
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