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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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 8-579 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)]
12/23/2019 Materials 8-500 Complete ISO 5832-12 Third edition 2019-02 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
12/20/2021 Materials 8-574 Complete ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
12/20/2021 Materials 8-576 Complete ASTM F451-21 Standard Specification for Acrylic Bone Cement
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
12/21/2020 Materials 8-544 Complete ASTM F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
12/21/2020 Materials 8-549 Complete ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
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)
06/07/2021 Materials 8-562 Complete ISO ASTM 52904 First edition 2019-08 Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications
07/15/2019 Materials 8-517 Complete ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1: General requirements
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 8-548 Complete ISO ASTM 52915 Third edition 2020-03 Specification for additive manufacturing file format (AMF) Version 1.2
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 8-400 Complete ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
09/17/2018 Materials 8-475 Complete ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
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
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
12/21/2020 Materials 8-550 Complete ASTM F2181-20 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
05/30/2022 Materials 8-592 Complete ASTM F3384-21 Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
12/21/2020 Materials 8-551 Complete ASTM F2895-20 Standard Practice for Digital Radiography of Cast Metallic Implants
12/21/2020 Materials 8-553 Complete ISO ASTM 52903-1 First edition 2020-04 Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials
12/20/2021 Materials 8-564 Complete ASTM F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys
06/07/2021 Materials 8-557 Complete ASTM F3268-18a Standard Guide for in vitro Degradation Testing of Absorbable Metals
12/19/2022 Materials 8-595 Complete ISO 5832-5 Fourth Edition 2022-03 Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel
06/07/2021 Materials 8-560 Complete ASTM D1415-18 Standard Test Method for Rubber Property - International Hardness
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
12/23/2024 Materials 8-624 Complete ASTM F2129-24 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
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
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
12/23/2019 Materials 8-491 Complete ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
01/14/2019 Materials 8-487 Complete ISO ASTM 52910-18 Additive manufacturing - Design - Requirements, guidelines and recommendations
08/21/2017 Materials 8-449 Complete 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)
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
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)
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)
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 8-458 Complete ASTM G5-14 Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements
07/06/2020 Materials 8-527 Complete ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments
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
08/21/2017 Materials 8-453 Complete ASTM F1295-16 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
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
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
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)
12/23/2016 Materials 8-442 Complete ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
12/23/2016 Materials 8-444 Complete ISO 17296-2 First edition 2015-01-15 Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock
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 8-484 Complete ASTM F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
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
07/15/2019 Materials 8-510 Complete ASTM F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
01/30/2014 Materials 8-358 Complete ASTM F1855-00 (Reapproved 2019) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
07/15/2019 Materials 8-514 Complete ISO 5834-2 Fifth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
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 8-516 Complete ISO 13779-4 Second edition 2018-12 Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
12/21/2020 Materials 8-554 Complete ISO ASTM TR 52912 First edition 2020-09 Additive manufacturing - Design - Functionally graded additive manufacturing
12/21/2020 Materials 8-545 Complete ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
05/29/2024 Materials 8-613 Complete ASTM F2527-24 Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants
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)
12/21/2020 Materials 8-540 Complete ASTM F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
12/21/2020 Materials 8-541 Complete ASTM F1537-20 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
12/21/2020 Materials 8-542 Complete ASTM F138-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
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 8-533 Complete ISO ASTM 52907: First Edition 2019-11 Additive Manufacturing - Feedstock materials - Methods to characterize metal powders
01/14/2019 Materials 8-488 Complete ASTM F3301-18a Standard for Additive Manufacturing - Post Processing Methods - Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion
07/09/2014 Materials 8-378 Complete ASTM D792-13 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
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)]
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
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
07/15/2019 Materials 8-518 Complete ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants
04/04/2016 Materials 8-409 Partial ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
09/17/2018 Materials 8-473 Partial ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
01/14/2019 Materials 8-179 Partial ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
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
05/29/2024 Materials 8-614 Complete ASTM F3456-22 Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials
05/29/2024 Materials 8-615 Complete ISO ASTM 52926-1 First edition 2023-11 Additive manufacturing of metals - Qualification principles - Part 1: General qualification of operators
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
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
05/29/2023 Materials 8-599 Complete ASTM F1295-22 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
12/21/2020 Materials 8-543 Partial ASTM F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
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
01/14/2019 Nanotechnology 18-11 Complete ISO TR 13121 First edition 2011-05-15 Nanotechnologies - Nanomaterial risk evaluation
06/07/2018 Nanotechnology 18-10 Complete ISO 29701 First edition 2010-09-15 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test.
01/14/2019 Nanotechnology 18-6 Complete ASTM E2865-12 (Reapproved 2022) Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials
12/21/2020 Nanotechnology 18-17 Complete ISO 21363 First edition 2020-06 Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy
07/06/2020 Nanotechnology 18-16 Complete ISO TS 21362 First edition 2018-06 Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation
12/20/2021 Nanotechnology 18-19 Complete ISO 19749 First edition 2021-07 Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
01/14/2019 Nanotechnology 18-8 Complete ASTM E2578-07 (Reapproved 2022) Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions
12/20/2021 Nanotechnology 18-20 Complete ASTM E3275-21 Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis
01/14/2019 Nanotechnology 18-7 Complete ASTM E2834-12 (Reapproved 2022) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA)
01/14/2019 Nanotechnology 18-5 Complete ASTM E2859-11 (Reapproved 2017) Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
12/19/2022 Nanotechnology 18-21 Complete ISO TS 80004-6 Second edition 2021-03 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
12/19/2022 Nanotechnology 18-22 Complete ISO 17200 First edition 2020-09 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
05/29/2023 Nanotechnology 18-23 Complete ASTM E3025-22 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
07/06/2020 Nanotechnology 18-15 Complete ASTM E3025-16 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
06/07/2018 Nanotechnology 18-9 Complete ISO TR 13014 First edition 2012-05-15 Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)].
 
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