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ASTM Medical Device Standards ASTM is one of the leading standards developers for medical devices. With 24 categories, addressing everything from surgical implements to automated analysis, ASTM medical device standards cover a truly wide range. With how much research and training goes into the medical industry, standardization plays a key role in productively actualizing that effort. Organized below for your convenience by usage, industry, and theme are over 300 standards.

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  • Cells and Tissue Engineered Constructs for TEMPs
  • Ceramic Materials
  • Classification and Terminology for TEMPs
  • Computer Assisted Orthopaedic Surgical Systems
  • Editorial and Terminology
  • GI Applications
  • Human Clinical Trials
  • Implantable Hearing Devices (IHDs
  • Material Test Methods
  • Metallurgical Materials
  • Neurosurgical Standards
  • Osteosynthesis
  • Plastic and Reconstructive Surgery
  • Polymeric Materials
  • Spinal Devices
  • Urological Materials and Devices

  • Medical/Surgical Instruments

    Medical/Surgical Instruments

    ASTM F1980-16

    Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

    ASTM E1061-01(2014)

    Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers

    ASTM F1026-86(2014)

    Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps

    ASTM F1079-87(2014)

    Standard Specification for Inserted and Noninserted Surgical Scissors

    ASTM F3014-14

    Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures

    ASTM E1112-00(2011)

    Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

    ASTM F921-10(2011)

    Standard Terminology Relating to Hemostatic Forceps

    ASTM F1078-10(2011)

    Standard Terminology for Surgical ScissorsInserted and Non-Inserted Blades

    ASTM F1874-98(2011)

    Standard Test Method for Bend Testing of Needles Used in Surgical Sutures

    ASTM F2062-00(2011)

    Standard Specification for Square Drive Interconnections on Surgical Instruments

    ASTM E1299-96(2016)

    Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature

    ASTM E667-98(2009)

    Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers

    ASTM E825-98(2016)

    Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature

    ASTM E1104-98(2016)

    Standard Specification for Clinical Thermometer Probe Covers and Sheaths

    ASTM E1965-98(2016)

    Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

    ASTM F1840-10(2016)

    Standard Terminology for Surgical Suture Needles

    ASTM F1325-91(2016)

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

    ASTM F1613-95(2016)

    Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)

    ASTM F1638-95(2016)e1

    Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)

    ASTM F1744-96(2016)

    Standard Guide for Care and Handling of Stainless Steel Surgical Instruments

    ASTM F2132-01(2008)e1

    Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps


    Adventitious Agents Safety

    Adventitious Agents Safety

    ASTM F2383-11

    Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)


    Arthroplasty

    Arthroplasty

    ASTM F3161-16

    Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions

    ASTM F1781-15

    Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

    ASTM F1814-15

    Standard Guide for Evaluating Modular Hip and Knee Joint Components

    ASTM F2068-15

    Standard Specification for Femoral Prostheses—Metallic Implants

    ASTM F2091-15

    Standard Specification for Acetabular Prostheses

    ASTM F2385-15

    Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs

    ASTM F2722-15

    Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops

    ASTM F3047M-15

    Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations

    ASTM F3141-15

    Standard Guide for Total Knee Replacement Loading Profiles

    ASTM F1223-14

    Standard Test Method for Determination of Total Knee Replacement Constraint

    ASTM F1357-14

    Standard Specification for Articulating Total Wrist Implants

    ASTM F1672-14

    Standard Specification for Resurfacing Patellar Prosthesis

    ASTM F2028-14

    Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

    ASTM F2582-14

    Standard Test Method for Impingement of Acetabular Prostheses

    ASTM F2943-14

    Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants

    ASTM F2979-14

    Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses

    ASTM F2665-09(2014)

    Standard Specification for Total Ankle Replacement Prosthesis

    ASTM F2724-08(2014)

    Standard Test Method for Evaluating Mobile Bearing Knee Dislocation

    ASTM F1820-13

    Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices

    ASTM F2580-13

    Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis

    ASTM F2978-13

    Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging

    ASTM F2996-13

    Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems

    ASTM F1714-96(2013)

    Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices

    ASTM F2345-03(2013)

    Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

    ASTM F2723-13a

    Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation

    ASTM F1378-12

    Standard Specification for Shoulder Prostheses

    ASTM F1800-12

    Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

    ASTM F2033-12

    Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

    ASTM F2083-12

    Standard Specification for Knee Replacement Prosthesis

    ASTM F2025-06(2012)

    Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment

    ASTM F2009-00(2011)

    Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

    ASTM F2777-16

    Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

    ASTM F1829-16

    Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear


    Assessment for TEMPs

    Assessment for TEMPs

    ASTM F2721-09(2014)

    Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects

    ASTM F2529-13

    Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) Active Standard

    ASTM F2884-12

    Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion

    ASTM F2903-11

    Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair

    ASTM F2451-05(2010)

    Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage


    Biocompatibility Test Methods

    Biocompatibility Test Methods

    ASTM F619-14

    Standard Practice for Extraction of Medical Plastics

    ASTM F1904-14

    Standard Practice for Testing the Biological Responses to Particles in vivo

    ASTM F1983-14

    Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

    ASTM E1262-88(2013)

    Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay

    ASTM F720-13

    Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

    ASTM F749-13

    Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

    ASTM F756-13

    Standard Practice for Assessment of Hemolytic Properties of Materials

    ASTM F1408-97(2013)

    Standard Practice for Subcutaneous Screening Test for Implant Materials

    ASTM F1439-03(2013)

    Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

    ASTM F1984-99(2013)

    Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

    ASTM F2148-13

    Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

    ASTM F2888-13

    Standard Test Method for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials

    ASTM F2901-13

    Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

    ASTM F719-81(2012)

    Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

    ASTM F750-87(2012)

    Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse

    ASTM F813-07(2012)

    Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

    ASTM F1027-86(2012)

    Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

    ASTM F895-11(2016)

    Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

    ASTM F748-16

    Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

    ASTM F763-04(2016)

    Standard Practice for Short-Term Screening of Implant Materials

    ASTM F981-04(2016)

    Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone

    ASTM F1877-16

    Standard Practice for Characterization of Particles

    ASTM F1903-10

    Standard Practice for Testing for Biological Responses to Particles In Vitro

    ASTM F2147-01(2016)

    Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

    ASTM F2382-04(2010)

    Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)

    ASTM 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


    Biomaterials and Biomolecules for TEMPs

    Biomaterials and Biomolecules for TEMPs

    ASTM F2347-15

    Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

    ASTM F2791-15

    Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions

    ASTM F2064-14

    Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

    ASTM F2952-14

    Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold

    ASTM F3089-14

    Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions

    ASTM F2150-13

    Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products

    ASTM 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)

    ASTM 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

    ASTM F2603-06(2012)

    Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds

    ASTM F2259-10(2012)e1

    Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

    ASTM F2260-03(2012)e1

    Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

    ASTM 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

    ASTM F2212-11

    Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

    ASTM 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

    ASTM F2900-11

    Standard Guide for Characterization of Hydrogels used in Regenerative Medicine

    ASTM F2450-10

    Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products

    ASTM F2027-16

    Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

    ASTM F2605-16

    Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)


    Cardiovascular Standards

    Cardiovascular Standards

    ASTM F3172-15

    Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices

    ASTM F3067-14

    Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents

    ASTM F2514-08(2014)

    Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

    ASTM F2606-08(2014)

    Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

    ASTM F2942-13

    Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

    ASTM F3036-13

    Standard Guide for Testing Absorbable Stents

    ASTM F1830-97(2013)

    Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps

    ASTM F1841-97(2013)

    Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

    ASTM F2079-09(2013)

    Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

    ASTM F2081-06(2013)

    Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

    ASTM F2394-07(2013)

    Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

    ASTM F2477-07(2013)

    Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

    ASTM F2914-12

    Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

    ASTM F2743-11

    Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems


    Cell Signaling

    Cell Signaling

    ASTM F2998-14

    Guide for Using Fluorescence Microscopy to Quantify the Spread Area of Fixed Cells


    Cells and Tissue Engineered Constructs for TEMPs

    Cells and Tissue Engineered Constructs for TEMPs

    ASTM F3088-14

    Standard Test Method for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions

    ASTM F3106-14

    Standard Guide for in vitro Osteoblast Differentiation Assays

    ASTM F2997-13

    Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis

    ASTM 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

    ASTM F2315-11

    Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

    ASTM F2664-11

    Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods

    ASTM F2739-16

    Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds

    ASTM F2149-16

    Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions


    Ceramic Materials

    Ceramic Materials

    ASTM F1926/F1926M-14

    Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings

    ASTM F1185-03(2014)

    Standard Specification for Composition of Hydroxylapatite for Surgical Implants

    ASTM F1609-08(2014)

    Standard Specification for Calcium Phosphate Coatings for Implantable Materials

    ASTM F2224-09(2014)

    Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

    ASTM F603-12(2016)

    Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

    ASTM F1581-08(2016)

    Standard Specification for Composition of Anorganic Bone for Surgical Implants

    ASTM F2393-12(2016)

    Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications

    ASTM F1088-04a(2010)

    Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

    ASTM F2024-10(2016)

    Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

    ASTM F1538-03(2009)

    Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation


    Classification and Terminology for TEMPs

    Classification and Terminology for TEMPs

    ASTM F3163-16

    Standard Guide for Classification of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds

    ASTM F2211-13

    Standard Classification for Tissue Engineered Medical Products (TEMPs)

    ASTM F2312-11

    Standard Terminology Relating to Tissue Engineered Medical Products

    ASTM F2311-08

    Standard Guide for Classification of Therapeutic Skin Substitutes


    Computer Assisted Orthopaedic Surgical Systems

    Computer Assisted Orthopaedic Surgical Systems

    ASTM F3107-14

    Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

    ASTM F2554-10

    Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems


    Editorial and Terminology

    Editorial and Terminology

    ASTM F2809-10

    Standard Terminology Relating to Medical and Surgical Materials and Devices


    GI Applications

    GI Applications

    ASTM F2528-06(2014)

    Standard Test Methods for Enteral Feeding Devices with a Retention Balloon


    Human Clinical Trials

    Human Clinical Trials

    ASTM F3037-15

    Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)


    Implantable Hearing Devices (IHDs

    Implantable Hearing Devices (IHDs

    ASTM F2504-05(2014)

    Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices


    Material Test Methods

    Material Test Methods

    ASTM F1854-15

    Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

    ASTM F2052-15

    Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

    ASTM F1536-95(2015)e1

    Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape

    ASTM F2003-02(2015)

    Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air

    ASTM F2255-05(2015)

    Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading

    ASTM F2256-05(2015)

    Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading

    ASTM F2258-05(2015)

    Standard Test Method for Strength Properties of Tissue Adhesives in Tension

    ASTM F2392-04(2015)

    Standard Test Method for Burst Strength of Surgical Sealants

    ASTM F2458-05(2015)

    Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants

    ASTM F2778-09(2015)

    Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)

    ASTM F2819-10(2015)e1

    Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices

    ASTM F746-04(2014)

    Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

    ASTM F1160-14

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

    ASTM F1801-97(2014)

    Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials

    ASTM F1875-98(2014)

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

    ASTM F2118-14

    Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

    ASTM F2516-14

    Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

    ASTM F3044-14

    Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants

    ASTM F561-13

    Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

    ASTM F897-02(2013)

    Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws

    ASTM F2102-13

    Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants

    ASTM F2119-07(2013)

    Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

    ASTM F2503-13

    Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

    ASTM F2754/F2754M-09(2013)

    Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire

    ASTM F2977-13

    Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants

    ASTM F2995-16

    Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids

    ASTM F640-12

    Standard Test Methods for Determining Radiopacity for Medical Use

    ASTM F1978-12

    Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

    ASTM F2459-12

    Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

    ASTM F2182-11a

    Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging

    ASTM F1044-05(2011)e1

    Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

    ASTM F732-00(2011)

    Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

    ASTM F1147-05(2011)

    Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

    ASTM F1635-16

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

    ASTM F2213-06(2011)

    Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

    ASTM F2537-06(2011)

    Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion

    ASTM F2004-16

    Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

    ASTM 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

    ASTM F2625-10(2016)

    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 F2847-10

    Standard Practice for Reporting and Assessment of Residues on Single Use Implants

    ASTM F1634-95(2016)

    Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices

    ASTM F2214-16

    Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)


    Metallurgical Materials

    Metallurgical Materials

    ASTM F629-15

    Standard Practice for Radiography of Cast Metallic Surgical Implants

    ASTM F1350-15

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

    ASTM F2005-05(2015)

    Standard Terminology for Nickel-Titanium Shape Memory Alloys

    ASTM F2895-15

    Standard Practice for Digital Radiography of Cast Metallic Implants

    ASTM F620-11(2015)

    Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition

    ASTM F90-14

    Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

    ASTM F688-14

    Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

    ASTM F961-14

    Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)

    ASTM F1108-14

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

    ASTM F1472-14

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

    ASTM F2181-14

    Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants

    ASTM F2257-14

    Standard Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)

    ASTM F67-13

    Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

    ASTM F86-13

    Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

    ASTM F136-13

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

    ASTM F562-13

    Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

    ASTM F601-13

    Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

    ASTM F1377-13

    Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

    ASTM F1713-08(2013)

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

    ASTM F1813-13

    Standard Specification for Wrought Titanium12 Molybdenum6 Zirconium2 Iron Alloy for Surgical Implant (UNS R58120)

    ASTM F2146-13

    Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)

    ASTM F2633-13

    Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants

    ASTM F2989-13

    Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications

    ASTM F3046-13

    Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320)

    ASTM 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)

    ASTM F560-13e1

    Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

    ASTM F1586-13e1

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

    ASTM F2066-13e1

    Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

    ASTM F138-13a

    Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

    ASTM F899-12b

    Standard Specification for Wrought Stainless Steels for Surgical Instruments

    ASTM F75-12

    Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

    ASTM F139-12

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

    ASTM F621-12

    Standard Specification for Stainless Steel Forgings for Surgical Implants

    ASTM F1091-12

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

    ASTM F1580-12

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

    ASTM F2063-12

    Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

    ASTM F2229-12

    Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)

    ASTM F2581-12

    Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)

    ASTM F799-11

    Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

    ASTM F1295-16

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

    ASTM F1537-11

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

    ASTM F2885-11

    Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications

    ASTM F1089-10

    Standard Test Method for Corrosion of Surgical Instruments

    ASTM F2384-10(2016)

    Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)

    ASTM F2527-16

    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 F2886-10

    Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

    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)


    Neurosurgical Standards

    Neurosurgical Standards

    ASTM F452-76(2014)

    Standard Specification for Preformed Cranioplasty Plates

    ASTM F647-94(2014)

    Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

    ASTM F700-93(2014)

    Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments

    ASTM F1831-97(2014)

    Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices

    ASTM F701-81(2008)

    Standard Practice for Care and Handling of Neurosurgical Implants and Instruments

    ASTM F982-86(2008)

    Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion

    ASTM F1266-89(2008)

    Standard Performance Specification for Cerebral Stereotactic Instruments

    ASTM F1719-96(2008)

    Standard Specification for Image-Interactive Stereotactic and Localization Systems


    Osteosynthesis

    Osteosynthesis

    ASTM F366-10(2015)

    Standard Specification for Fixation Pins and Wires

    ASTM F564-10(2015)

    Standard Specification and Test Methods for Metallic Bone Staples

    ASTM F1541-02(2015)

    Standard Specification and Test Methods for External Skeletal Fixation Devices

    ASTM F2180-02(2015)

    Standard Specification for Metallic Implantable Strands and Cables

    ASTM F382-14

    Standard Specification and Test Method for Metallic Bone Plates

    ASTM F1264-16e1

    Standard Specification and Test Methods for Intramedullary Fixation Devices

    ASTM F565-04(2013)

    Standard Practice for Care and Handling of Orthopedic Implants and Instruments

    ASTM F983-86(2013)

    Standard Practice for Permanent Marking of Orthopaedic Implant Components

    ASTM F1611-00(2013)

    Standard Specification for Intramedullary Reamers

    ASTM F543-13e1

    Standard Specification and Test Methods for Metallic Medical Bone Screws

    ASTM F116-12(2016)

    Standard Specification for Medical Screwdriver Bits

    ASTM F384-12

    Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

    ASTM F1839-08(2016)

    Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

    ASTM F2502-11

    Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants


    Plastic and Reconstructive Surgery

    Plastic and Reconstructive Surgery

    ASTM F881-94(2014)

    Standard Specification for Silicone Elastomer Facial Implants

    ASTM F1441-03(2014)

    Standard Specification for Soft-Tissue Expander Devices

    ASTM F2051-00(2014)

    Standard Specification for Implantable Saline Filled Breast Prosthesis


    Polymeric Materials

    Polymeric Materials

    ASTM F2848-16

    Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns

    ASTM F624-09(2015)e1

    Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

    ASTM F602-09(2015)

    Standard Criteria for Implantable Thermoset Epoxy Plastics

    ASTM F639-09(2015)

    Standard Specification for Polyethylene Plastics for Medical Applications

    ASTM F665-09(2015)

    Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application

    ASTM F754-08(2015)

    Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

    ASTM F3087-15

    Standard Specification for Acrylic Molding Resins for Medical Implant Applications

    ASTM F641-09(2014)

    Standard Specification for Implantable Epoxy Electronic Encapsulants

    ASTM F648-14

    Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

    ASTM F2026-16

    Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

    ASTM F2565-13

    Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

    ASTM F2695-12

    Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications

    ASTM F2820-12

    Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications

    ASTM F2902-16

    Standard Guide for Assessment of Absorbable Polymeric Implants

    ASTM F755-99(2011)

    Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

    ASTM F1855-00(2011)

    Standard Specification for Polyoxymethylene (Acetal) for Medical Applications

    ASTM F2038-00(2011)

    Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

    ASTM F2042-00(2011)

    Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

    ASTM F2759-11

    Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices

    ASTM F702-10

    Standard Specification for Polysulfone Resin for Medical Applications

    ASTM F997-10

    Standard Specification for Polycarbonate Resin for Medical Applications

    ASTM 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

    ASTM F2579-10

    Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

    ASTM F1925-09

    Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

    ASTM F451-16

    Standard Specification for Acrylic Bone Cement


    Spinal Devices

    Spinal Devices

    ASTM F1717-15

    Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

    ASTM F2789-10(2015)

    Standard Guide for Mechanical and Functional Characterization of Nucleus Devices

    ASTM F2077-14

    Test Methods For Intervertebral Body Fusion Devices

    ASTM F2193-14

    Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

    ASTM F2706-08(2014)

    Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

    ASTM F2790-10(2014)

    Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses

    ASTM F1798-13

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

    ASTM F2694-16

    Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

    ASTM F2624-12(2016)

    Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs

    ASTM F1582-98(2016)

    Standard Terminology Relating to Spinal Implants

    ASTM F2267-04(2011)

    Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

    ASTM F2346-05(2011)

    Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

    ASTM F2423-11(2016)

    Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses


    Urological Materials and Devices

    Urological Materials and Devices

    ASTM F1828-97(2014)

    Standard Specification for Ureteral Stents

    ASTM F623-99(2013)

    Standard Performance Specification for Foley Catheter