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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2024 Materials 8-616 Complete ISO ASTM 52926-2 First edition 2023-11 Additive manufacturing of metals - Qualification principles - Part 2: Qualification of operators for PBF-LB
06/27/2016 Materials 8-426 Complete ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
06/27/2016 Materials 8-430 Complete 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 8-432 Complete ISO ASTM 52921 First Edition 2013-06-01 Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies.
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
12/23/2019 Materials 8-519 Complete ISO 13782 Second edition 2019-04 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
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
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
05/29/2024 Materials 8-612 Complete ASTM F899-23 Standard Specification for Wrought Stainless Steels for Surgical Instruments
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
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 8-481 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)
12/23/2019 Materials 8-480 Complete ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
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
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
01/14/2019 Materials 8-487 Complete ISO ASTM 52910-18 Additive manufacturing - Design - Requirements, guidelines and recommendations
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
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
12/21/2020 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
12/23/2019 Materials 8-491 Complete ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
07/09/2014 Materials 8-378 Complete ASTM D792-13 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
05/29/2024 Materials 8-611 Complete ISO 9584 Second edition 2023-10 Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic 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
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 8-472 Complete ASTM F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
09/17/2018 Materials 8-474 Complete ASTM F2886-17 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
12/21/2020 Materials 8-544 Complete ASTM F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
06/07/2018 Materials 8-464 Complete ISO TS 10974 Second edition 2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
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)
09/17/2018 Materials 8-465 Complete ISO 5832-2 Fourth edition 2018-03 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
06/07/2018 Materials 8-463 Complete ISO ASTM 52901 First edition 2017-08 Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts
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 8-401 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
04/04/2016 Materials 8-408 Complete ASTM F3122-14 Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes
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
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)
12/23/2016 Materials 8-440 Complete ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
08/21/2017 Materials 8-226 Complete ASTM F603-12 (Reapproved 2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
04/04/2016 Materials 8-403 Complete ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
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)
 
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