List of Medical Device and Implant Standards

• ASTM F2554 – Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems
• ASTM F2565 – Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
• ASTM F2567 – Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
• ASTM F2528 – Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
• ASTM F2529 – Standard Guide for  in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
• ASTM F2537 – Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
• ASTM F2527 – Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
• ASTM F2502 – Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• ASTM F2503 – Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• ASTM F2504 – Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
• ASTM F2514 – Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
• ASTM F2516 – Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
• ASTM F2477 – Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
• ASTM F2450 – Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
• ASTM F2451 – Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage (Withdrawn 2019)
• ASTM F2458 – Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
• ASTM F2459 – Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
• ASTM F2423 – Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
• ASTM F2386 – Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
• ASTM F2392 – Standard Test Method for Burst Strength of Surgical Sealants
• ASTM F2393 – Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
• ASTM F2394 – Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System
• ASTM F2381 – Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
• ASTM F2382 – Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
• ASTM F2384 – Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)
• ASTM F2385 – Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
• ASTM F2345 – Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
• ASTM F2346 – Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
• ASTM F2347 – Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
• ASTM F2311 – Standard Guide for Classification of Therapeutic Skin Substitutes (Withdrawn 2017)
• ASTM F2312 – Standard Terminology Relating to Tissue Engineered Medical Products
• ASTM F2313 – Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
• ASTM F2315 – Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
• ASTM F2257 – Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
• ASTM F2258 – Standard Test Method for Strength Properties of Tissue Adhesives in Tension
• ASTM F2259 – Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy (Withdrawn 2021)
• ASTM F2260 – Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
• ASTM F2267 – Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
• ASTM F2255 – Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading
• ASTM F2256 – Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
• ASTM F2224 – Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• ASTM F2229 – Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
• ASTM F2210 – Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015)
• ASTM F2211 – Standard Classification for Tissue-Engineered Medical Products (TEMPs)
• ASTM F2212 – Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• ASTM F2213 – Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• ASTM F2214 – Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
• ASTM F2180 – Standard Specification for Metallic Implantable Strands and Cables
• ASTM F2181 – Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
• ASTM F2182 – Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
• ASTM F2183 – Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)
• ASTM F2193 – Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• ASTM F2150 – Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
• ASTM F2151 – Standard Practice for Assessment of White Blood Cell Morphology After Contact with Materials (Withdrawn 2007)
• ASTM F2131 – Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line
• ASTM F2132 – Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps (Withdrawn 2017)
• ASTM F2146 – Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
• ASTM F2147 – Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
• ASTM F2148 – Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
• ASTM F2149 – Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
• ASTM F2118 – Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
• ASTM F2119 – Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Withdrawn 2022)
• ASTM F2129 – Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
• ASTM F2091 – Standard Specification for Acetabular Prostheses
• ASTM F2102 – Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
• ASTM F2103 – Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
• ASTM F2079 – Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
• ASTM F2081 – Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
• ASTM F2082/F2082M – Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
• ASTM F2083 – Standard Specification for Knee Replacement Prosthesis
• ASTM F2068 – Standard Specification for Femoral Prostheses—Metallic Implants
• ASTM F2077 – Standard Test Methods for Intervertebral Body Fusion Devices
• ASTM F2051 – Standard Specification for Implantable Saline-Filled Breast Prostheses
• ASTM F2052 – Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• ASTM F2062 – Standard Specification for Square Drive Interconnections on Surgical Instruments
• ASTM F2064 – Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
• ASTM F2065 – Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
• ASTM F2066 – Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
• ASTM F2027 – Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• ASTM F2028 – Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
• ASTM F2033 – Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
• ASTM F2038 – Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
• ASTM F2042 – Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
• ASTM F2025 – Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
• ASTM F2026 – Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• ASTM F2009 – Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
• ASTM F2024 – Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• ASTM F1984 – Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
• ASTM F1992 – Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes (Withdrawn 2016)
• ASTM F2003 – Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
• ASTM F2004 – Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
• ASTM F2005 – Standard Terminology for Nickel-Titanium Shape Memory Alloys
• ASTM F1978 – Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
• ASTM F1983 – Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
• ASTM F1925 – Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
• ASTM F1926/F1926M – Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
• ASTM F1903 – Standard Practice for Testing for Cellular Responses to Particles in vitro
• ASTM F1904 – Standard Practice for Testing the Biological Responses to Particles in vivo
• ASTM F1905 – Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)
• ASTM F1906 – Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011)

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