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List of Medical Device and Implant Standards

427 standards

American National Standards Institute Inc.

  • ASTM F1877 – Standard Practice for Characterization of Particles

  • ASTM F1874 – Standard Test Method for Bend Testing of Needles Used in Surgical Sutures (Withdrawn 2020)

  • ASTM F1875 – Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

  • ASTM F1876 – Standard Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications (Withdrawn 2012)

  • ASTM F1854 – Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

  • ASTM F1855 – Standard Specification for Polyoxymethylene (Acetal) for Medical Applications

  • ASTM F1873 – Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007)

  • ASTM F1828 – Standard Specification for Ureteral Stents

  • ASTM F1829 – Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

  • ASTM F1830 – Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps

  • ASTM F1831 – Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices

  • ASTM F1839 – Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

  • ASTM F1840 – Standard Terminology for Surgical Suture Needles

  • ASTM F1841 – Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

  • ASTM F1813 – Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)

  • ASTM F1814 – Standard Guide for Evaluating Modular Hip and Knee Joint Components

  • ASTM F1820 – Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices

  • ASTM F1798 – Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

  • ASTM F1800 – Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

  • ASTM F1801 – Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials

  • ASTM F1781 – Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

  • ASTM F1744 – Standard Guide for Care and Handling of Stainless Steel Surgical Instruments

  • ASTM F1745 – Test Method for External Fixator Connectors (Withdrawn 2000)

  • ASTM F1746 – Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements (Withdrawn 2000)

  • ASTM F1747 – Test Method for External Fixator Joints (Withdrawn 2000)

  • ASTM F1748 – Test Method for External Fixator Subassemblies (Withdrawn 2000)

  • ASTM F1719 – Standard Specification for Image-Interactive Stereotactic and Localization Systems (Withdrawn 2017)

  • ASTM F1713 – Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)

  • ASTM F1714 – Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices

  • ASTM F1715 – Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices (Withdrawn 2006)

  • ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

  • ASTM F1691 – Test Method for Determining Axial Pull-Out Strength of Medical Bone Screws (Withdrawn 2001)

  • ASTM F1672 – Standard Specification for Resurfacing Patellar Prosthesis

  • ASTM F1658 – Test Method for Shear Testing of Calcium Phosphate Coatings (Withdrawn 2000)

  • ASTM F1659 – Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates (Withdrawn 2005)

  • ASTM F1660 – Test Method for Elastic Static Bending of Metallic Bone Staples (Withdrawn 2000)

  • ASTM F1634 – Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices (Withdrawn 2017)

  • ASTM F1635 – Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

  • ASTM F1636 – Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)

  • ASTM F1638 – Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)

  • ASTM F1609 – Standard Specification for Calcium Phosphate Coatings for Implantable Materials

  • ASTM F1610 – Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples (Withdrawn 2000)

  • ASTM F1611 – Standard Specification for Intramedullary Reamers

  • ASTM F1612 – Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion (Withdrawn 2011)

  • ASTM F1613 – Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)

  • ASTM F1622 – Test Method for Measuring the Torsional Properties of Metallic Bone Screws (Withdrawn 2001)

  • ASTM F1582 – Standard Terminology Relating to Spinal Implants

  • ASTM F1586 – Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)

  • ASTM F1581 – Standard Specification for Composition of Anorganic Bone for Surgical Implants

  • ASTM F1579 – Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011)

  • ASTM F1580 – Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants

  • ASTM F1537 – Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

  • ASTM F1538 – Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

  • ASTM F1539 – Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples (Withdrawn 2000)

  • ASTM F1540 – Test Method for Pull-Out Fixation Strength of Metallic Bone Staples (Withdrawn 2000)

  • ASTM F1541 – Standard Specification and Test Methods for External Skeletal Fixation Devices

  • ASTM F1542 – Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips (Withdrawn 2009)

  • ASTM F1518 – Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera (Withdrawn 2009)

  • ASTM F1536 – Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape (Withdrawn 2021)

  • ASTM F1501 – Test Method for Tension Testing of Calcium Phosphate Coatings (Withdrawn 2000)

  • ASTM F1472 – Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

  • ASTM F1439 – Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

  • ASTM F1440 – Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion (Withdrawn 2012)

  • ASTM F1441 – Standard Specification for Soft-Tissue Expander Devices

  • ASTM F1408 – Standard Practice for Subcutaneous Screening Test for Implant Materials

  • ASTM F139 – Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

  • ASTM F136 – Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

  • ASTM F1377 – Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)

  • ASTM F1378 – Standard Specification for Shoulder Prostheses

  • ASTM F1341 – Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications (Withdrawn 2006)

  • ASTM F1350 – Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

  • ASTM F1357 – Standard Specification for Articulating Total Wrist Implants

  • ASTM F1314 – 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)

  • ASTM F1325 – Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods

  • ASTM F1295 – Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

  • ASTM F1266 – Standard Performance Specification for Cerebral Stereotactic Instruments (Withdrawn 2017)

  • ASTM F1251 – Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)

  • ASTM F1264 – Standard Specification and Test Methods for Intramedullary Fixation Devices

  • ASTM F1223 – Standard Test Method for Determination of Total Knee Replacement Constraint

  • ASTM F1185 – Standard Specification for Composition of Hydroxylapatite for Surgical Implants

  • ASTM F1160 – Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

  • ASTM F116 – Standard Specification for Medical Screwdriver Bits

  • ASTM F117 – Test Method for Driving Torque of Medical Bone Screws (Withdrawn 2001)

  • ASTM F1147 – Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

  • ASTM F1088 – Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

  • ASTM F1089 – Standard Test Method for Corrosion of Surgical Instruments

  • ASTM F1091 – Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)

  • ASTM F1108 – Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

  • ASTM F1078 – Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades

  • ASTM F1079 – Standard Specification for Inserted and Noninserted Surgical Scissors

  • ASTM F1044 – Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

  • ASTM F1058 – Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)

  • ASTM F1026 – Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps

  • ASTM F1027 – Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

  • ASTM F1028 – Specification for Tri-Fin Nails (Withdrawn 1996)

  • ASTM E825 – Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature

  • ASTM E667 – Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers (Withdrawn 2022)

  • ASTM E1965 – Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

  • ASTM E1398 – Standard Practice for In Vivo Rat Hepatocyte DNA Repair Assay (Withdrawn 2014)

  • ASTM E1397 – Standard Practice for In Vitro Rat Hepatocyte DNA Repair Assay (Withdrawn 2014)

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