List of Medical Device and Implant Standards

• ASTM F3273 – Standard Specification for Wrought Molybdenum-47.5 Rhenium Alloy for Surgical Implants (UNS R03700)
• ASTM F3274 – Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
• ASTM F3275 – Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
• ASTM F3276 – 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
• ASTM F3259 – Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
• ASTM F3260 – Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
• ASTM F3223 – Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
• ASTM F3224 – Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
• ASTM F3225 – Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
• ASTM F3212 – Standard Test Method for Coring Testing of Huber Needles
• ASTM F3206 – Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
• ASTM F3207 – Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
• ASTM F3208 – Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
• ASTM F3209 – Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy
• ASTM F3210 – Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
• ASTM F3211 – Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
• ASTM F3160 – Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• ASTM F3161 – Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
• ASTM F3163 – Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
• ASTM F3172 – Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
• ASTM F3127 – Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
• ASTM F3129 – Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
• ASTM F3140 – Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
• ASTM F3141 – Standard Guide for Total Knee Replacement Loading Profiles
• ASTM F3142 – Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs
• ASTM F3143 – Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
• ASTM F3106 – Standard Guide for in vitro Osteoblast Differentiation Assays
• ASTM F3107 – Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
• ASTM F3108 – Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
• ASTM F3109 – Standard Practice for Verification of Multi-Axis Force Measuring Platforms
• ASTM F3087 – Standard Specification for Acrylic Molding Resins for Medical Implant Applications
• ASTM F3088 – Standard Practice for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions
• ASTM F3089 – Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
• ASTM F3090 – Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
• ASTM F3067 – Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
• ASTM F3044 – Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
• ASTM F3046 – Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320)
• ASTM F3047M – Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
• ASTM F3036 – Standard Guide for Testing Absorbable Stents
• ASTM F3037 – Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)
• ASTM F3014 – Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures
• ASTM F3018 – Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
• ASTM F2989 – Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
• ASTM F2995 – Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids
• ASTM F2996 – Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
• ASTM F2997 – Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis
• ASTM F2998 – Guide for Using Fluorescence Microscopy to Quantify the Spread Area of Fixed Cells
• ASTM F2977 – Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
• ASTM F2978 – Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
• ASTM F2979 – Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
• ASTM F2942 – Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
• ASTM F2943 – Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
• ASTM F2944 – Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
• ASTM F2952 – Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
• ASTM F2901 – Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
• ASTM F2902 – Standard Guide for Assessment of Absorbable Polymeric Implants
• ASTM F2903 – Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
• ASTM F2914 – Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
• ASTM F2900 – Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
• ASTM F2883 – Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)
• ASTM F2884 – Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
• ASTM F2885 – Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
• ASTM F2886 – Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
• ASTM F2887 – Standard Specification for Total Elbow Prostheses
• ASTM F2888 – Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
• ASTM F2895 – Standard Practice for Digital Radiography of Cast Metallic Implants
• ASTM F2847 – Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
• ASTM F2848 – Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
• ASTM F2808 – Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
• ASTM F2819 – Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
• ASTM F2820 – Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
• ASTM F2789 – Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• ASTM F2790 – Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
• ASTM F2791 – Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
• ASTM F2759 – Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
• ASTM F2777 – Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
• ASTM F2778 – Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)
• ASTM F2739 – Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
• ASTM F2743 – Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
• ASTM F2754/F2754M – Standard Test Method for Measurement of Camber, Cast, Helix, and Direction of Helix of Coiled Wire
• ASTM F2706 – Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
• ASTM F2721 – Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
• ASTM F2722 – Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
• ASTM F2723 – Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
• ASTM F2724 – Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
• ASTM F2694 – Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
• ASTM F2695 – Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• ASTM F2664 – Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
• ASTM F2665 – Standard Specification for Total Ankle Replacement Prosthesis
• ASTM F2633 – Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
• ASTM F2624 – Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• ASTM F2625 – 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
• ASTM F2579 – Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
• ASTM F2580 – Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
• ASTM F2581 – Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
• ASTM F2582 – Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
• ASTM F2602 – Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
• ASTM F2603 – Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
• ASTM F2605 – Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
• ASTM F2606 – Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems

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