Medical Device Standards and Implant Standards

    ASTM's medical device and implant standards are instrumental in specifying and evaluating the design and performance requirements of a number of biomedical materials, tools, and equipments. These apparatuses are used in surgical procedures that involve the placement of such devices to specified parts and structures of the body (both humans and animals) for the purpose of enhancement or as an aid in a disability. These medical device and implant standards allow material and product manufacturers, medical laboratories, and other concerned institutions to inspect and assess such instruments to ensure proper quality and workmanship.

    List of medical device standards and implant standards developed by ASTM:


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    Adventitious Agents Safety

    DesignationTitle
    F2383 - 11 Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)

    Arthroplasty

    DesignationTitle
    F1223 - 08(2012) Standard Test Method for Determination of Total Knee Replacement Constraint
    F1357 - 09 Standard Specification for Articulating Total Wrist Implants
    F1378 - 12 Standard Specification for Shoulder Prostheses
    F1672 - 95(2011) Standard Specification for Resurfacing Patellar Prosthesis
    F1714 - 96(2013) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
    F1781 - 03(2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
    F1800 - 12 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
    F1814 - 97a(2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components
    F1820 - 13 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
    F1829 - 98(2009) Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear
    F2009 - 00(2011) Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
    F2025 - 06(2012) Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
    F2028 - 08(2012)e1 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
    F2033 - 12 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
    F2068 - 09 Standard Specification for Femoral Prostheses—Metallic Implants
    F2083 - 12 Standard Specification for Knee Replacement Prosthesis
    F2091 - 01(2012) Standard Specification for Acetabular Prostheses
    F2345 - 03(2013) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
    F2385 - 04(2010) Standard Test Method for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
    F2580 - 13 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
    F2582 - 08 Standard Test Method for Impingement of Acetabular Prostheses
    F2665 - 09 Standard Specification for Total Ankle Replacement Prosthesis
    F2722 - 08 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
    F2723 - 13a Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
    F2724 - 08(2014) Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
    F2777 - 10 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
    F2887 - 12 Standard Specification for Total Elbow Prostheses
    F2943 - 13 Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
    F2996 - 13 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems

    Assessment for TEMPs

    DesignationTitle
    F2451 - 05(2010) Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
    F2529 - 13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
    F2721 - 09 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
    F2884 - 12 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
    F2903 - 11 Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair

    Biocompatibility Test Methods

    DesignationTitle
    E1262 - 88(2013) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
    E1263 - 97(2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
    E1280 - 97(2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity
    F619 - 03(2008) Standard Practice for Extraction of Medical Plastics
    F719 - 81(2012) Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
    F720 - 13 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
    F748 - 06(2010) Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
    F749 - 13 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
    F750 - 87(2012) Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
    F756 - 13 Standard Practice for Assessment of Hemolytic Properties of Materials
    F763 - 04(2010) Standard Practice for Short-Term Screening of Implant Materials
    F813 - 07(2012) Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
    F895 - 11 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
    F981 - 04(2010) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
    F1027 - 86(2012) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
    F1408 - 97(2013) Standard Practice for Subcutaneous Screening Test for Implant Materials
    F1439 - 03(2013) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
    F1877 - 05(2010) Standard Practice for Characterization of Particles
    F1903 - 10 Standard Practice for Testing For Biological Responses to Particles In Vitro
    F1904 - 98(2008) Standard Practice for Testing the Biological Responses to Particles in vivo
    F1983 - 99(2008) Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
    F1984 - 99(2013) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
    F2065 - 00(2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
    F2147 - 01(2010) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
    F2148 - 13 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
    F2382 - 04(2010) Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
    F2567 - 06(2010) Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials
    F2808 - 10 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
    F2888 - 13 Standard Test Method for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
    F2901 - 13 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

    Biomaterials and Biomolecules for TEMPs

    DesignationTitle
    F2027 - 08 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
    F2064 - 00(2006)e1 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
    F2103 - 11 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
    F2131 - 02(2012) 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
    F2150 - 13 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
    F2212 - 11 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
    F2259 - 10(2012)e1 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
    F2260 - 03(2012)e1 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
    F2347 - 11 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
    F2450 - 10 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products
    F2602 - 13 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)
    F2603 - 06(2012) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
    F2605 - 08e1 Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
    F2791 - 09 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
    F2883 - 11 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications
    F2900 - 11 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine

    Cardiovascular Standards

    DesignationTitle
    F1830 - 97(2013) Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps
    F1841 - 97(2013) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
    F2079 - 09(2013) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
    F2081 - 06(2013) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
    F2394 - 07(2013) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
    F2477 - 07(2013) Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
    F2514 - 08(2014) Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
    F2606 - 08(2014) Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems
    F2743 - 11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
    F2914 - 12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
    F2942 - 13 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
    F3036 - 13 Standard Guide for Testing Absorbable Stents

    Cells and Tissue Engineered Constructs for TEMPs

    DesignationTitle
    F2149 - 01(2007) Standard Test Method for Automated Analyses of Cells-the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
    F2210 - 02(2010) Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
    F2315 - 11 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
    F2664 - 11 Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
    F2739 - 08 Standard Guide for Quantitating Cell Viability Within Biomaterial Scaffolds
    F2944 - 12 Standard Test Method for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
    F2997 - 13 Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis

    Ceramic Materials

    DesignationTitle
    F603 - 12 Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
    F1088 - 04a(2010) Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    F1185 - 03(2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants
    F1538 - 03(2009) Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
    F1581 - 08(2012) Standard Specification for Composition of Anorganic Bone for Surgical Implants
    F1609 - 08(2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
    F1926 / F1926M - 10 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
    F2024 - 10 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
    F2224 - 09(2014) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
    F2393 - 12 Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications

    Classification and Terminology for TEMPs

    DesignationTitle
    F2211 - 13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
    F2311 - 08 Standard Guide for Classification of Therapeutic Skin Substitutes
    F2312 - 11 Standard Terminology Relating to Tissue Engineered Medical Products

    Computer Assisted Orthopaedic Surgical Systems

    DesignationTitle
    F2554 - 10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

    Editorial and Terminology

    DesignationTitle
    F2809 - 10 Standard Terminology Relating to Medical and Surgical Materials and Devices

    GI Applications

    DesignationTitle
    F1992 - 99(2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes
    F2528 - 06 Standard Test Methods for Enteral Feeding Devices with a Retention Balloon

    Implantable Hearing Devices (IHDs)

    DesignationTitle
    F2504 - 05(2014) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices

    Material Test Methods

    DesignationTitle
    F561 - 13 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
    F640 - 12 Standard Test Methods for Determining Radiopacity for Medical Use
    F732 - 00(2011) Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
    F746 - 04(2009)e1 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
    F897 - 02(2013) Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
    F1044 - 05(2011)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
    F1089 - 10 Standard Test Method for Corrosion of Surgical Instruments
    F1147 - 05(2011) Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
    F1160 - 05(2011)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
    F1536 - 95(2010) Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape
    F1634 - 95(2008) Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
    F1635 - 11 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
    F1801 - 97(2009)e1 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
    F1854 - 09 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
    F1875 - 98(2009) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
    F1978 - 12 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
    F2003 - 02(2008) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
    F2004 - 05(2010) Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
    F2052 - 06e1 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    F2082 - 06 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
    F2102 - 13 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
    F2118 - 10 Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
    F2119 - 07(2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
    F2129 - 08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
    F2182 - 11a Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
    F2183 - 02(2008) Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
    F2213 - 06(2011) Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    F2214 - 02(2008) Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
    F2255 - 05(2010) Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading
    F2256 - 05(2010) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
    F2258 - 05(2010) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
    F2381 - 10 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
    F2392 - 04(2010) Standard Test Method for Burst Strength of Surgical Sealants
    F2458 - 05(2010) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
    F2459 - 12 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
    F2503 - 13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    F2516 - 07e2 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
    F2537 - 06(2011) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
    F2625 - 10 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
    F2754 / F2754M - 09(2013) Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
    F2778 - 09 Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)
    F2819 - 10 Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
    F2847 - 10 Standard Practice for Reporting and Assessment of Residues on Single Use Implants
    F2977 - 13 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
    F2995 - 13 Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids

    Medical/Surgical Instruments

    DesignationTitle
    E667 - 98(2009) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
    E825 - 98(2009) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
    E1061 - 01(2007) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
    E1104 - 98(2009) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
    E1112 - 00(2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
    E1299 - 96(2010) Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature
    E1965 - 98(2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
    F921 - 10(2011) Standard Terminology Relating to Hemostatic Forceps
    F1026 - 86(2008)e1 Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps
    F1078 - 10(2011) Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
    F1079 - 87(2008)e1 Standard Specification for Inserted and Noninserted Surgical Scissors
    F1325 - 91(2008)e1 Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods
    F1613 - 95(2008)e1 Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
    F1638 - 95(2008)e1 Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)
    F1744 - 96(2008)e1 Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
    F1840 - 10e1 Standard Terminology for Surgical Suture Needles
    F1874 - 98(2011) Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
    F2062 - 00(2011) Standard Specification for Square Drive Interconnections on Surgical Instruments
    F2132 - 01(2008)e1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps

    Metallurgical Materials

    DesignationTitle
    F67 - 13 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
    F75 - 12 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
    F86 - 13 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
    F90 - 09 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
    F136 - 13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
    F138 - 13a Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
    F139 - 12 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
    F560 - 13e1 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
    F562 - 13 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
    F601 - 13 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
    F620 - 11 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
    F621 - 12 Standard Specification for Stainless Steel Forgings for Surgical Implants
    F629 - 11 Standard Practice for Radiography of Cast Metallic Surgical Implants
    F688 - 10 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
    F799 - 11 Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
    F899 - 12b Standard Specification for Wrought Stainless Steels for Surgical Instruments
    F961 - 08 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
    F1058 - 08 Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)
    F1091 - 12 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
    F1108 - 04(2009) Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
    F1295 - 11 Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
    F1314 - 13ae1 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)
    F1350 - 08 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
    F1377 - 13 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
    F1472 - 08e1 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
    F1537 - 11 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
    F1580 - 12 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
    F1586 - 13e1 Standard Specification for Wrought Nitrogen Strengthened 21Chromium-10Nickel-3Manganese-2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
    F1713 - 08(2013) Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)
    F1813 - 13 Standard Specification for Wrought Titanium–12 Molybdenum–6 Zirconium–2 Iron Alloy for Surgical Implant (UNS R58120)
    F2005 - 05(2010) Standard Terminology for Nickel-Titanium Shape Memory Alloys
    F2063 - 12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
    F2066 - 13e1 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
    F2146 - 13 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
    F2181 - 09 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
    F2229 - 12 Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
    F2257 - 09 Standard Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
    F2384 - 10 Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)
    F2527 - 10 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)
    F2581 - 12 Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
    F2633 - 13 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
    F2885 - 11 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
    F2886 - 10 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
    F2895 - 10 Standard Practice for Digital Radiography of Cast Metallic Implants
    F2989 - 13 Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
    F3046 - 13 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320)

    Neurosurgical Standards

    DesignationTitle
    F452 - 76(2008) Standard Specification for Preformed Cranioplasty Plates
    F647 - 94(2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
    F700 - 93(2008) Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
    F701 - 81(2008) Standard Practice for Care and Handling of Neurosurgical Implants and Instruments
    F982 - 86(2008) Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion
    F1266 - 89(2008) Standard Performance Specification for Cerebral Stereotactic Instruments
    F1719 - 96(2008) Standard Specification for Image-Interactive Stereotactic and Localization Systems
    F1831 - 97(2006) Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices

    Osteosynthesis

    DesignationTitle
    F116 - 12 Standard Specification for Medical Screwdriver Bits
    F366 - 10 Standard Specification for Fixation Pins and Wires
    F382 - 99(2008)e1 Standard Specification and Test Method for Metallic Bone Plates
    F384 - 12 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
    F543 - 13e1 Standard Specification and Test Methods for Metallic Medical Bone Screws
    F564 - 10 Standard Specification and Test Methods for Metallic Bone Staples
    F565 - 04(2013) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
    F983 - 86(2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components
    F1264 - 03(2012) Standard Specification and Test Methods for Intramedullary Fixation Devices
    F1541 - 02(2011)e1 Standard Specification and Test Methods for External Skeletal Fixation Devices
    F1611 - 00(2013) Standard Specification for Intramedullary Reamers
    F1839 - 08(2012) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
    F2180 - 02(2011)e1 Standard Specification for Metallic Implantable Strands and Cables
    F2502 - 11 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

    Plastic and Reconstructive Surgery

    DesignationTitle
    F703 - 07 Standard Specification for Implantable Breast Prostheses
    F881 - 94(2006) Standard Specification for Silicone Elastomer Facial Implants
    F1441 - 03(2009) Standard Specification for Soft-Tissue Expander Devices
    F2051 - 00(2006) Standard Specification for Implantable Saline Filled Breast Prosthesis

    Polymeric Materials

    DesignationTitle
    F451 - 08 Standard Specification for Acrylic Bone Cement
    F602 - 09 Standard Criteria for Implantable Thermoset Epoxy Plastics
    F624 - 09 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
    F639 - 09 Standard Specification for Polyethylene Plastics for Medical Applications
    F641 - 09 Standard Specification for Implantable Epoxy Electronic Encapsulants
    F648 - 13 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
    F665 - 09 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
    F702 - 10 Standard Specification for Polysulfone Resin for Medical Applications
    F754 - 08 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
    F755 - 99(2011) Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
    F997 - 10 Standard Specification for Polycarbonate Resin for Medical Applications
    F1855 - 00(2011) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
    F1925 - 09 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
    F2026 - 12 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
    F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
    F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
    F2313 - 10 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
    F2565 - 13 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
    F2579 - 10 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    F2695 - 12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
    F2759 - 11 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
    F2820 - 12 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
    F2848 - 10 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
    F2902 - 12 Standard Guide for Assessment of Absorbable Polymeric Implants

    Spinal Devices

    DesignationTitle
    F1582 - 98(2011) Standard Terminology Relating to Spinal Implants
    F1717 - 14 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
    F1798 - 13 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
    F2077 - 11 Test Methods For Intervertebral Body Fusion Devices
    F2193 - 02(2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
    F2267 - 04(2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
    F2346 - 05(2011) Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
    F2423 - 11 Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
    F2624 - 12 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
    F2694 - 07(2013) Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
    F2706 - 08 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
    F2789 - 10 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
    F2790 - 10 Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses

    Urological Materials and Devices

    DesignationTitle
    F623 - 99(2013) Standard Performance Specification for Foley Catheter
    F1828 - 97(2006) Standard Specification for Ureteral Stents

    Other standards developed by ASTM committees:


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