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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/26/2025 Neurology 17-22 Complete IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
01/27/2015 Neurology 17-13 Complete IEEE Std 2010-2012 Recommended Practice for Neurofeedback Systems
01/30/2014 Neurology 17-12 Complete ISO 7197 Third edition 2006-06-01 Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
05/29/2024 Neurology 17-19 Partial ISO 80601-2-85 Edition 1.0 2021-03 Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
08/14/2015 Neurology 17-4 Partial ASTM F647-94 (Reapproved 2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
05/26/2025 Neurology 17-21 Partial ASTM F647-22 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
06/07/2018 Neurology 17-1 Partial AAMI NS28:1988/(R) 2015 Intracranial pressure monitoring devices
01/27/2015 Nanotechnology 18-3 Partial ISO TS 14101 First edition 2012-11-01 Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method
07/15/2019 Nanotechnology 18-14 Partial ISO TR 11360 First edition 2010-07-15 Nanotechnologies - Methodology for the classification and categorization of nanomaterials
07/15/2019 Nanotechnology 18-13 Partial ISO TS 18827 First edition 2017-06 Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials
01/14/2019 Nanotechnology 18-2 Partial ASTM E2535-07 (Reapproved 2018) Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
12/18/2023 Nanotechnology 18-24 Partial ASTM E2524-22 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
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
01/14/2019 Nanotechnology 18-11 Complete ISO TR 13121 First edition 2011-05-15 Nanotechnologies - Nanomaterial risk evaluation
05/29/2023 Nanotechnology 18-23 Complete ASTM E3025-22 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
01/14/2019 Nanotechnology 18-5 Complete ASTM E2859-11 (Reapproved 2017) Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
04/04/2016 Nanotechnology 18-1 Complete ASTM E2490-09 (Reapproved 2021) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
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)].
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
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
12/21/2020 Nanotechnology 18-18 Complete ASTM E3247-20 Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering
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
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
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
12/19/2022 Nanotechnology 18-22 Complete ISO 17200 First edition 2020-09 Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
12/19/2022 Nanotechnology 18-21 Complete ISO TS 80004-6 Second edition 2021-03 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
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 18-7 Complete ASTM E2834-12 (Reapproved 2022) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA)
06/07/2018 Materials 8-113 Complete ASTM F1147-05 (Reapproved 2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate and 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
05/30/2022 Materials 8-584 Complete ASTM F2146-22 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
06/07/2018 Materials 8-337 Complete ASTM F621-12 (Reapproved 2017) Standard Specification for Stainless Steel Forgings for Surgical Implants
06/07/2018 Materials 8-356 Complete ASTM F67-13 (Reapproved 2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
05/30/2022 Materials 8-585 Complete ASTM F1377-21 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
05/30/2022 Materials 8-586 Complete ASTM F2989-21 Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
12/20/2021 Materials 8-570 Complete ASTM F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
12/20/2021 Materials 8-571 Complete ASTM F2052-21 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
06/27/2016 Materials 8-434 Complete ISO ASTM 52900 First Edition 2015-12-15 Additive manufacturing -- General principles - Terminology
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
05/30/2022 Materials 8-593 Complete ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 Implants for surgery - Hydroxyapatite - Part 6: Powders
07/15/2019 Materials 8-509 Complete ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
01/14/2019 Materials 8-485 Complete ASTM F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
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
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
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
12/18/2023 Materials 8-605 Complete ASTM F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
04/04/2016 Materials 8-406 Complete ISO 5832-11 Second edition 2014-09-15 Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
09/17/2018 Materials 8-467 Complete ASTM F1978-18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
01/27/2015 Materials 8-383 Complete ASTM F1926/F1926M-14 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
05/29/2023 Materials 8-600 Complete ASTM F1978-22 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
12/20/2021 Materials 8-566 Complete ASTM F1813-21 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
05/29/2023 Materials 8-598 Complete ASTM F3109-22 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
12/20/2021 Materials 8-567 Complete ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
12/20/2021 Materials 8-568 Complete ASTM F1586-21 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
12/20/2021 Materials 8-569 Complete ASTM F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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
06/07/2021 Materials 8-558 Complete ASTM F3333-20 Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
01/14/2019 Materials 8-482 Complete ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique
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.
07/15/2019 Materials 8-504 Complete ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
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)
12/21/2020 Materials 8-546 Complete ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
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
04/04/2016 Materials 8-403 Complete ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
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
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 8-564 Complete ASTM F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys
12/20/2021 Materials 8-565 Complete ASTM F2754/F2754M-21 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
05/30/2022 Materials 8-588 Complete ASTM F560-22 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
05/30/2022 Materials 8-583 Complete ASTM F562-22 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
12/23/2024 Materials 8-623 Complete ASTM F1314-24 Standard Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
09/17/2018 Materials 8-479 Complete ISO 13781 Second edition 2017-07 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing
08/21/2017 Materials 8-459 Complete SAE AMS2750 Rev. E 2012-07 Pyrometry
08/21/2017 Materials 8-333 Complete ASTM F2393-12 (Reapproved 2020) Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
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
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
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
09/17/2018 Materials 8-478 Complete ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments
06/27/2016 Materials 8-427 Complete ASTM F1185-03 (Reapproved 2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants
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
12/21/2020 Materials 8-547 Complete ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
06/07/2021 Materials 8-561 Complete ISO ASTM 52950 First edition 2021-01 Additive manufacturing - General principles - Overview of data processing
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
12/20/2021 Materials 8-572 Complete ASTM F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
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)
06/07/2021 Materials 8-555 Complete ASTM F1472-20a Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
05/29/2023 Materials 8-604 Complete ASTM F2257-22 Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
06/07/2021 Materials 8-556 Complete ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use
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)
12/19/2022 Materials 8-594 Complete ISO 5832-6 Third Edition 2022-03 Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
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
12/20/2021 Materials 8-574 Complete ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
06/27/2016 Materials 8-431 Complete ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
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
 
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