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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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08/21/2017 InVitro Diagnostics 7-272 Partial CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
12/23/2016 InVitro Diagnostics 7-268 Partial CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
06/27/2016 InVitro Diagnostics 7-264 Partial CLSI MM21-1st Edition (Reaffirmed: January 2020) Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
05/29/2023 InVitro Diagnostics 7-317 Partial CLSI M100, 33rd Edition Performance Standards for Antimicrobial Susceptibility Testing
12/19/2022 InVitro Diagnostics 7-314 Partial CLSI M27M44S, 3rd Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts
07/15/2019 InVitro Diagnostics 7-291 Partial CLSI EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
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)
12/23/2019 Materials 8-501 Complete ISO 5834-1 Fourth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
12/21/2020 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)
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
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
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 8-481 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 8-521 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 8-522 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 8-534 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
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
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
07/15/2019 Materials 8-509 Complete ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
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 8-520 Complete ASTM F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
07/15/2019 Materials 8-510 Complete ASTM F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
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)
07/15/2019 Materials 8-493 Complete ISO 13779-2 Third edition 2018-12 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
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
12/23/2019 Materials 8-519 Complete ISO 13782 Second edition 2019-04 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
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
07/15/2019 Materials 8-504 Complete ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
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
12/20/2021 Materials 8-575 Complete ASTM F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
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
07/06/2020 Materials 8-533 Complete ISO ASTM 52907: First Edition 2019-11 Additive Manufacturing - Feedstock materials - Methods to characterize metal 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
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
05/29/2023 Materials 8-598 Complete ASTM F3109-22 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
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
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.
06/27/2016 Materials 8-434 Complete ISO ASTM 52900 First Edition 2015-12-15 Additive manufacturing -- General principles - Terminology
12/23/2016 Materials 8-441 Complete ASTM F3109-16 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
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 8-116 Complete ASTM F2258-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
01/27/2015 Materials 8-171 Complete ASTM F1609-08 (Reapproved 2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
04/04/2016 Materials 8-400 Complete ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical 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 8-449 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)
12/23/2016 Materials 8-442 Complete ASTM F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
09/17/2018 Materials 8-474 Complete ASTM F2886-17 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
09/17/2018 Materials 8-465 Complete ISO 5832-2 Fourth edition 2018-03 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
09/17/2018 Materials 8-112 Complete ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
09/17/2018 Materials 8-466 Complete ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
09/17/2018 Materials 8-478 Complete ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments
05/29/2023 Materials 8-602 Complete ASTM F2503-23 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
07/06/2020 Materials 8-528 Complete ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
01/30/2014 Materials 8-358 Complete ASTM F1855-00 (Reapproved 2019) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
07/09/2014 Materials 8-378 Complete ASTM D792-13 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
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
01/14/2019 Materials 8-487 Complete ISO ASTM 52910-18 Additive manufacturing - Design - Requirements, guidelines and recommendations
07/06/2020 Materials 8-527 Complete ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments
04/04/2016 Materials 8-403 Complete ASTM D638-14 Standard Test Method for Tensile Properties of Plastics
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 8-404 Complete ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth Rates
01/30/2014 Materials 8-159 Complete ISO 9584 First edition 1993-10-15 Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants
08/14/2015 Materials 8-389 Complete 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
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)
01/14/2019 Materials 8-482 Complete ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique
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
06/07/2021 Materials 8-556 Complete ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use
12/23/2016 Materials 8-440 Complete ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
12/18/2023 Materials 8-610 Complete ASTM F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
01/14/2019 Materials 8-483 Complete ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
09/17/2018 Materials 8-412 Complete ASTM F2537-06 (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
12/18/2023 Materials 8-607 Complete ASTM F2082/F2082M-23 Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
12/23/2016 Materials 8-437 Complete ASTM F2082/F2082M-16 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
09/17/2018 Materials 8-476 Complete ASTM F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
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
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)]
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)
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)
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
12/20/2021 Materials 8-580 Complete IEC 63145-20-10 Edition 1.0 2019-08 Eyewear display - Part 20-10: Fundamental measurement methods - Optical properties
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
12/20/2021 Materials 8-581 Complete IEC 63145-20-20 Edition 1.0 2019-09 Eyewear display - Part 20-20: Fundamental measurement methods - Image quality
12/20/2021 Materials 8-582 Complete IEC 63145-22-10 Edition 1.0 2020-01 Eyewear display - Part 22-10: Specific measurement methods for AR type - Optical properties
08/21/2017 Materials 8-459 Complete SAE AMS2750 Rev. E 2012-07 Pyrometry
08/21/2017 Materials 8-226 Complete ASTM F603-12 (Reapproved 2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
06/27/2016 Materials 8-431 Complete ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
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
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)
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
07/15/2019 Materials 8-496 Complete 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 Complete ISO 5834-5 Second edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
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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